Double Cone Rotary Vacuum Dryer: The Complete Buying Guide In 2025

Drying is an integral process in industries and improves product quality by reducing the moisture content that can lead to contamination and microbial growth. Hence, an industrial dryer is one of the most essential machines in production to control the drying rate and enhance the efficiency of manufacturing.

Double cone rotary vacuum dryer is one of many pharmaceutical dryers and is best for low-temperature and gentle drying, preserving the structural integrity of delicate substances. So, are you ready to install a double cone rotary vacuum dryer in your manufacturing unit; then do not look at other sites. This knowledgeable and interesting guide is written with the sole aim of educating you on advantages, working, uses, troubleshooting, and so much more regarding this machine. Let’s have an insight.

Add a header to begin generating the table of contents

1.What is meant by a double cone rotary vacuum dryer?

Allpack Double Cone Rotary Vacuum Dryer

A double cone rotary vacuum dryer is a renowned dryer that combines mixing and drying in one industrial equipment. It concentrates materials at low temperatures using a vacuum state. It is a cylindrical cone-shaped structure that achieves unvarying mixing and drying by the tumbling rotation of the drying chamber.

It has a slow rotational motion that results in the impact of materials against the walls of the drying chamber and causes consistent mixing of feed. In vacuum conditions, the materials are consistently heated through walls, which accelerates drying and decreases the length of the drying cycle. It capably performs drying by extracting various solvents and water from wet feed.

2.How is a double cone rotary vacuum dryer popular in industries?

A double cone rotary vacuum dryer is an extraordinary drying machine that offers various advantages to production facilities. It is typically popular in wide-ranging industries because of its safe, effective, and inexpensive drying. Have a look at the noteworthy pros of a double cone rotary vacuum dryer:

Effective Drying and Mixing

Effective Drying and Mixing- Picture Courtesy: Altana AG

The design of a double cone rotary vacuum dryer is cylinder-shaped, which aids in the full and consistent revolution of the feed. This even and uniform mixing results in continuous agitation and tumbling of feed, drastically maximizing the surface area of the product for evaporation. This not only prevents agglomeration but also allows an effective and improved drying rate.

Increased Solvent Recovery

Increased Solvent Recovery

A double cone rotary vacuum dryer is increasingly popular in manufacturing units because it has excellent solvent recovery. The low-temperature drying in this machine lowers the boiling point of liquids and these solvent vapors are collected and recovered with the help of a condenser- installed with a drying machine. This recovery of solvents is very advantageous for industries, where precious and expensive solvents are used again and again in manufacturing.

Reduced Contamination Risk

Reduced Contamination Risk- Picture Courtesy: P-Met

This machine has a fully enclosed structure with a gap between a cylindrical body and a vacuum pipe sealed from durable and strong Teflon materials, resulting in airtight securing of the drying chamber. Furthermore, drying in this machine happens in the presence of a vacuum that prevents the entrance of gases and other contaminants inside the drying chamber. This reduces the risk of contamination and maintains sterile and hygienic conditions for product manufacturing.

High Energy Efficiency

High Energy Efficiency

Low energy consumption is the biggest benefit of a double cone rotary vacuum dryer. Less amount of energy is required to heat and dry materials, reducing operational expenditures needed to maintain the facility. Energy-efficient drying is achieved with vacuum processing and tumbling motion in this dryer. Moreover, it cut down thermal degradation, making it a safe drying machine for different feed groups.

Low Maintenance

Low Maintenance

A double cone rotary vacuum dryer has a straightforward construction with fewer rotating components that are easily assembled and disassembled, which allows ease in maintaining, cleaning, and operating the machine. Moreover, decreased maintenance requirements and convenient cleaning increase the lifespan of the machine, making it a hit among manufacturers- looking for ways to save finances.

3.Where does a double cone rotary vacuum dryer find its use?

A double cone rotary vacuum dryer is fabricated to attain outclass efficiency in drying operations. It has exceedingly reduced end moisture values, thus most industrial units prefer integrating this machine into their facilities. Let’s learn about the distinct uses of a double cone rotary vacuum dryer:

Pharmaceutical Industry

Pharmaceutical Pills

In the pharmaceutical industry, wet granulations and wet mixing are involved, therefore, wet masses are routinely dried in this industry by a double cone rotary vacuum dryer. This machine is very useful in rapidly drying the moisture content of active drug ingredients, excipients, and other pharmaceutical materials without causing any damage to their therapeutic properties. This device is typically used for its controlled drying operation to attain stability in drug formulations.

Chemical Industry

Chemicals- Picture Courtesy: RIAC

A double cone rotary vacuum dryer is an ideal device for processing delicate, thermos-sensitive, and, reactive chemicals. This machine is integral in extracting moisture from fine chemical powders, catalysts, and, other sensitive chemicals. It does not cause undesired chemical deterioration and prevents the reactivity of various chemicals while drying.

Food Industry

Food

In a double cone rotary vacuum dryer, different food products, for instance, flavors, snacks, coffee, tea, herbs, spices, and dairy powders are successfully dried. This machine is excellent for mixing and drying because it preserves crucial properties, such as aroma, freshness, flavor, texture, and, the appearance of food ingredients. In this way, more safe and gentle drying of food products is attained.

Dye and Pigment Industry

Dye and Pigments

An application of a double cone rotary vacuum dryer is very beneficial because it offers superior and meticulous drying rates. Pigments and dyes used in paints and other coloring products are extremely heat-sensitive, so a double cone rotary vacuum dryer is effective in removing their solvent content and assists in upholding their color intensity, vibrancy, saturation, and hue. This drying device also aids in attaining optimized products with uniform characteristics.

Biotechnology Industry

Biotechnology Industry- Picture Courtesy: Surf Search

This drying machine is ideal for dehydrating different types of heat-sensitive and bioactive substances, for example, proteins, enzymes, antibiotics, amino acids, and vitamins. Low-temperature drying in a double cone rotary vacuum dryer is best for preserving the structure and functions of biological molecules. Controlled drying conditions under vacuum conditions do not denature and degrade vaccines and other biologics.

Agriculture Industry

Agriculture Industry

In the agriculture industry, various types of seeds and plants are dried with the help of a double cone rotary vacuum dryer to retain their traits and efficacy. It excels in drying feed and other agricultural compounds and produces top-notch and stable end-products for quality control procedures.

Ceramic Industry

Ceramic

In this industry, vast and diverse types of products are manufactured-ranging from conventional pottery to high-tech ceramic goods. A double cone rotary vacuum dryer is a superior machine that offers gentle dehydration of delicate ceramic structures. Low-temperature drying and precise moisture extraction are suitable for preserving the integrity of ceramics without warping them.

4.What are the working stages of a double cone rotary vacuum dryer?

A double cone rotary vacuum dryer is recommended in industrial settings because of its efficient solvent vaporization and increase in expiration dates of various materials. Learning about the working stages of this machine is important for engineers and developers, as it helps in operating and maintaining the machine. Let’s understand the working stages of a double cone rotary vacuum dryer:

Loading of Feed

Loading of Feed- Picture Courtesy: MegaFood

At the start, raw feed (wet mass, slurry, or paste) is introduced inside the drying chamber of a double cone rotary vacuum dryer through the top inlet. The quantity of feed placed inside the device is based on the processing needs and working capacity of a dryer. Usually, about 30-50% of the drying chamber is loaded to give space to feed for rapid movement during rotation.

Sealing and Vacuum Formation

Sealing and Vacuum Formation- Picture Courtesy: Italvacuum

As soon as the feed is deposited in the drying chamber, it is airtightly sealed to prevent the access of air inside the device. After sealing, the vacuum pump present in a double cone rotary vacuum dryer decreases the inside pressure by extracting air inside the device. Vacuum formation is essential for reducing the boiling point of the solvents, consequently, removal of solvents and drying occur at decreased temperatures.

Material Heating and Evaporation

Material Heating and Evaporation

This device is composed of three jacketed layers that provide insulation to prevent heat losses. The heat source, such as steam, conductive oil, or hot water is applied to the middle layer. Due to rotation, materials continuously and uniformly come in contact with heated walls.

The inner moisture comes to the surface due to heat transference and moisture saturation leads to evaporation under low temperatures. These solvent vapors are extracted out of the chamber through a vacuum pump and are recovered by collection in the condenser.

Cooling and Drying

Cooling and Drying- Picture Courtesy: Daxner

After complete drying, the jacketed shell of drying is cooled by use of chilled water. This lowers the product temperature before unloading so that heat-sensitive materials are not damaged. Finally, the vacuum is gradually released from the drying chamber and the inner pressure is returned to normal.

Afterward, the material is offloaded from the machine by a lower outlet. The tilting of cone-like configuration assists in feed removal and complete discharge, reducing feed retention.

5.What is the structural configuration of a double cone rotary vacuum dryer?

A double cone is a cylindrical device and its top and bottom parts are conical. It has a speed reducer, motor, and manhole. The basic components of a double cone rotary vacuum dryer are mentioned below:

Parts of a Double Cone Rotary Vacuum Dryer

Motor	The motor is integral in a double cone rotary vacuum dryer and is responsible for powering the machine, which helps in the rotation and tumbling of feed. It is located on one side of the device and is attached to a rotary vessel through a gearbox.
Inlet	The feed to be dried is loaded inside the drying chamber through the inlet port. This opening is specially engineered to conveniently introduce the materials in the device. It is situated on the top end of the machine.
Drying Chamber	It is a central part of the machine and drying procedures occur in this part. With the rotation of this vessel on the central axis, materials tumbled and heated with contact with the external jacket system.
Stand/Frame	The entire device is supported by a strong and durable frame or stand. It balances the drying vessel and allows its rotation. This structure reduces the vibration of the machine during the drying operation.
Guard Rail	It is a safety feature present around the rotating cylindrical structure to avert unintentional contact during the drying process. It is necessary for operator safety.
Outlet	The dried feed is offloaded from the machine by a port located at the bottom of the drying barrel. This discharge port has a conical structure that easily discharges feed by gravity.
Control Panel	The drying procedure is regulated and managed by the control panel. With the help of this computerized panel, operators can easily input the operational inputs, such as rotational speed, pressure, drying time, etc.
Condenser	The vaporized moisture is collected and condensed in the condenser. It converts vapor back into liquid for recovery. It is integrated with vacuum lines and is present at the periphery of the vacuum pump to aid in cooling and collection.
Rotary Joint or Connector	This part is integral in the distribution of heating liquid to a jacketed layer of the machine. It is found between an immobile heating source and a drying chamber.
Heat source	The function of the heating source is to deliver heat for drying. It supplies steam, hot water, and oils to a rotary joint that in turn moves them to the jacket for circulation and drying of material.
Condensate Pipe	It is a connection between the condenser and the drying chamber. It disposes of the vapors to the condensate trap and is integral in the recycling of solvents.
Filter	This type of filter is equipped with a vacuum to protect the vacuum pump or condenser from fine particles, dust, debris, and residues. The particulates cause blockage of a vacuum pump and decrease its throughout.
Seal Seat	It offers sealing to crucial components, like outlet, inlet, and vacuum pipes to uphold the vacuum inside the chamber by decreasing air leaks.
Vacuum Valve	This valve is important in regulating the vacuum level in the drying vessel. It is located along vacuum pipes and manages the removal of air and moisture.

6.What materials are specially dried in a double cone rotary vacuum dryer?

Let's go into details of the type of materials, well suited for drying in a double cone rotary vacuum dryer.

Readily Oxidizable and Hazardous Materials

Flammable Materials

Do your materials oxidize readily, or are they hazardous? This dryer produces an inert environment, making it ideal for:

Sensitive chemicals: materials that may be flammable or degrade in the presence of oxygen.

Pharmaceuticals: sensitive drugs or chemicals that react to open air.

Materials That Need Solvent Recovery

Managing Toxic Gasses

Want to recover solvents or manage toxic gases safely? Then this dryer is best for you.

Recovery of solvents used in pharmaceutical manufacturing, thereby, decreasing your cost and making you comply with the environmental requirements.

Managing poisonous vapors and safe drying of volatile compounds.

Crystalline Materials

Crystalline Compounds

If your material needs to stay in its crystalline form, then this dryer will not hurt it, as it works very tenderly. Therefore, it is best for:

Crystalline drugs: drugs that need to retain their structure during drying.

Fine chemicals: easily impacted by changed structure or chemical composition.

Low Residual Volatile Content Materials

Specialty Polymers

The vacuum process in a double cone rotary vacuum dryer enables you to reach very low residual content quickly, which is perfectly suited for cemicals of the highest purity, where minor moisture can be critical and specialty polymers.

Toxic or Irritant Materials

Toxic Materials

Dealing with toxic or highly irritant substances? The closed system of this dryer ensures the handling and processing of the following toxic matetrials, such as pesticides that are toxic materials and must be carefully dealt with as well as chemical intermediates- dangerous substances that require a controlled environment.

7.What is the rotational speed of a double cone rotary vacuum dryer?

Rotational Speed of a Double Cone Rotary Vacuum Dryer- Picture Courtesy: CRIOX® System

The double cone rotary vacuum dryer has a rapid drying rate and one expects it to have fast rotational speed. On the other hand, it rotates slowly with a speed of 3-20 revolutions per minute. It has a slower speed because of several reasons, such as:

First, the measured rotational speed of a double cone rotary vacuum dryer allows gentle tumbling and even encounters with heated walls. This prevents the loss of structural integrity and high frictional force during drying. Moreover, feed does not adhere to edges and dead zones in the drying chamber with the help of consistent rotation. This results in uniform drying processes.

Also, higher speed leads to over-agitation of materials and their clumping, so slow rotational speed in this drying machine prevents irregular distribution of feed.

8.What are the typical maintenance procedures for a double cone rotary vacuum dryer?

Here are the step-by-step procedures in the maintenance procedures for a double cone rotary vacuum dryer that can be carried out systematically:

Double cone rotary vacuum dryer- Picture Courtesy: Griffin Machinery

Vacuum System Check

Check the vacuum pipes for blockages or obstructions in the vacuum pipeline.

Check if vacuum pump seals are intact and free of leaks.

Check if the air rubber seals on the rotating bearing have to be replaced.

Electrical System Checks

Check electrical contacts- The entire connection must be secure with no sign of wear and tear.

Check the grounding wire- This should be in good condition as well to avoid any risk of electric fires or shocks.

Heating System Maintenance

Check the heating medium if the thermal oil or hot water circulating in the right manner.

Check the heating elements, if the temperature falls in the range as required while working with an efficiency level.

Check for leaks and address any signs of overheating or leakage promptly.

Lubrication of Mechanical Components

Lubricate bearings and chains- Apply or replace lubricating oil or grease regularly to prevent wear and tear.

Replace worn-out lubricants and fresh lubricants should be applied at intervals, especially on moving parts.

Cleaning and Disinfection

Clean drying chamber- Remove any residue from the drying chamber after every use.

Disinfect the chambers and follow proper sanitation protocols, especially in industries like pharmaceuticals.

Filter and Exhaust System Maintenance

Clean air filters- regularly clean the filters to avoid any blockages.

Check the exhaust system and ensure there is no abnormal pressure or obstruction in the airflow.

Overload Prevention

Monitor material load- Instruct operators to maintain a recommended 30-50% chamber capacity.

Examine material bulk density- Ensure the material does not exceed 0.6 g/cm³ as higher could reduce efficiency and impact dryer life.

Adjust Vacuum System

Monitor vacuum pressure- Keep the vacuum level in an appropriate range during drying. Avoid too low and too high.

Check for leaks or blockages-Resolve any pipeline issues that may lead to fluctuations in vacuum levels.

Noise Reduction

Tighten loose parts- Fix any loose bolts or components to reduce noise. Inspect bearings and chains-Lubricate or replace parts causing excessive noise.

Wall Material Buildup Prevention

Clean the drying chamber walls- Regularly remove any material buildup on the inner chamber walls.

Optimize feed rate and temperature- Adjust the drying speed and temperature to prevent materials from sticking.

Calibration

Calibration of sensors- Ensure accurate readings from vacuum and temperature sensors

Check Gauges- Pressure gauges must display the pressure within satisfactory limits.

9.How to troubleshoot frequent problems encountered in a double cone rotary vacuum dryer?

A double cone rotary vacuum dryer is a state-of-the-art machine, designed for decreasing downtimes and maximizing efficiency. Still, it faces occasional technical issues that negatively impact its productivity. However, these issues are easily managed by proper knowledge and training. Hence, for your information, we are penning some frequent problems and their solutions for a double cone rotary vacuum dryer:

Product Contamination

Product Contamination- Picture Courtesy: Unitak

Cause

Troubleshooting

Due to insufficient and improper cleaning from earlier batches, the end-products are cross-contaminated in the dryer.

Sometimes, there are loose connections or leakage in the vacuum chamber due to which contaminants enter the drying vessel.

To avoid contamination, it is ideal to integrate a Clean-in-Place (CIP) system to thoroughly clean the machine between batches.

Also, examine and secure every sealing of the machine to avert the entry of contaminants.

Slow Drying Time

Slow Drying Time- Picture Courtesy: MicroFood

Cause

Troubleshooting

The slow drying time is because of several causes, for instance, decreased vacuum pressure or leakage. Improper heat distribution is due to improper temperature programming.

The feed substances have a higher amount of moisture.

To increase drying efficiency, it is best to:

Inspect the leaks in the vacuum mechanism and verify the correct working order of the vacuum pump.

Review the temperature inputs and alter them as per the requirement of feed.

Also, pre-dry the feed to extract surplus moisture before loading it into the drying machine.

Clogging in Vapor Pipe

Clogging in Vapor Pipe- Picture Courtesy: Mr. Rooter Plumbing

Cause

Troubleshooting

Sometimes, there is a reduced flow of vapors through the vapor pipe because of clogging of vapor lines. The possible causes of this issue are:

The buildup of particulates or product residues inside the vapor pipe or condenser.

Insufficient vapor transfer is also owing to improper vacuum settings.

To resolve this problem, you must:

Properly and completely clean the vapor pipe for extracting any undesired product buildup. Secondly, properly assess the vacuum valve for accurate functionality and ensure every setting of the vacuum level is properly input.

Material Leak from the Drying Chamber

Material Leak from the Drying Chamber- Picture courtesy; Capovani Brothers Inc.

Cause

Troubleshooting

Have you ever seen feed dripping from the drying chamber? It can be due to damaged, rusty, old, and defective seals, usually present on inlet and outlet ports or vacuum valves. The defective construction, for instance, cracking or breakage in the drying vessel also causes leakage.

It is recommended to follow these tips to rectify this problem:

You must examine and switch old and defective seals, bearings, gaskets, and O-rings at loading or discharge ports.

Routinely evaluate the drying chamber for defects and replace or repair depending upon the requirement.

Overheating of Feed

Overheating of Feed- Picture Courtesy: Oxara

Cause

Troubleshooting

This issue is due to:

Wrong temperature input or defective heating elements.

Drying temperatures exceed because of poor vacuum levels.

You must resolve this problem by:

Recalibrating temperature control mechanism and verifying that the heating element is at the correct temperature.

Checking the vacuum system to verify its seamless working efficiency.

Inspecting heat transfer via jacket and ascertaining that rotary joint is performing as expected.

Conclusion

A double cone rotary vacuum dryer is a one-stop and turnkey solution for effectively, swiftly, hygienically, and, safely drying thermo-sensitive, hygroscopic, delicate, toxic, and volatile substances. Its constant rotation and low-pressure conditions are pivotal in smooth and seamless drying. It is a well-prioritized device in not only healthcare sectors but also in developmental and manufacturing areas because of its sustainability and profitability. So, after reading a huge array of advantages are you now tempted to add a double cone rotary vacuum dryer to your productions? If yes, you are invited to look at the catalog of Allpack’s affordable, high-tech, and efficient drying machine. We are a world leader in designing reliable and FDA-compliant machines.

Don't forget to share this post!

CONTACT US

Tell us your raw material and project budget to get quotations within 24 hours.

WhatsApp Us: +86 181 7101 8586

The Buyer's Guide

Want to get Best Price Double Cone Rotary Vacuum Dryer from China?

Tell us your material or budget, we'll reply you ASAP within 24 hours

Double Cone Rotary Vacuum Dryer: The Complete Buying Guide In 2025 Read More »

ISO VS GMP

Pharmaceutical Standard

ISO VS GMP

Are you involved in the manufacturing sector? Do you want to produce quality goods? Do your industrial regulations include compliance with quality assurance standards? Are you confused about the differences between ISO and GMP? Do you have questions regarding the scope and objectives of ISO and GMP?

The answers to the above-mentioned questions and more will be detailed in this enlightening blog: “ISO VS GMP”. ISO and GMP are similar in various aspects, such as maintaining records, training of operators, calibration of equipment, and product quality tests. Here we will focus on the differences between ISO and GMP so that you can understand the requirements of these regulations and implement them in your business. Let’s start reading.

Add a header to begin generating the table of contents

1.What is Meant by ISO?

ISO

ISO stands for International Organization for Standardization and is an international body formed from national standard agencies. Its purpose is to create and publish a variety of proprietary, industrial, and commercial protocols.

ISO was created in 1947 in London, United Kingdom. It provides a regulatory framework for running an organization and audits its activity. It is a globally accepted standardized quality management protocol valid for every type of production. It has been reported on ISO website that approximately 1.2 million organizations in 170 world countries have been ISO certified.

It focuses on different facets of seamlessly establishing and managing businesses and is committed to continuously improving quality across every procedure and level of organization. It deals with the requirements of managing and fulfilling customer demands.

2.What is Meant by GMP?

GMP- Picture Courtesy: Angstrom Technology

GMP stands for Good Manufacturing Practices. Sometimes, it is also called cGMP or current Good Manufacturing Practice. GMP regulations uphold a special place in fulfilling the quality assurance protocols and developing quality-compliant products.

It encompasses every facet of the manufacturing process to protect against any catastrophic hazards that degrade the product quality, safety, and potency. It guarantees that products are optimized for their expected use and adhere to marketing or clinical trial regulations.

In 1941, after substandard and contaminated sulfathiazole tablets adversely affected about 300 people, the Food and Drug Administration (FDA) revised manufacturing protocols significantly, leading to the establishment of GMP. These regulations were first finalized in the 1960s and the FDA published its GMP standards in 1963 to prevent contamination of pharmaceuticals and drug formulation errors and ascertain product reliability.

3.What are the Differences between ISO and GMP?

Both ISO and GMP certifications are crucial to quality assessment approaches and by adhering to these regulations, manufacturers and developers can attain fineness in product formulation and provision of services in far and wide productions. They are vastly different from each other, serve immensely diverse objects, and are applicable in dissimilar settings. Let’s look into detail of key differences between ISO and GMP one by one:

Differences between ISO and GMP

Purpose

Purpose

Purpose- Picture Courtesy: Meet Recruitment

The main purpose of ISO regulations is to increase operation performance quality, effectiveness, and, consumer trust in diverse industries. Its primary job is to make a structural framework and process-centric methodology to establish quality assurance.

GMP is specially devised to ensure every regulated industry- producing health-related and beauty-related products- conforms to quality standards in manufacturing, processing, packing, handling, and storage. It is product-oriented and deals with the shortcomings of products that adversely affect the well-being of humans.

Focus

Focus

Focus- Picture Courtesy: Alcimed

ISO and GMP differ significantly in their focus. ISO is related to the organization's general management and is strongly focused on customer opinions- both external and internal. It includes standards for satisfying customer demands, fulfilling their expectations, and gaining customer trust. It is more committed to enhancing the management of the business. It usually mandates organizations to devise quality policies and goals.

It is usually focused on running the business in the right way, although one of its goals is to manufacture the right quality product, it has other objectives, such as establishing responsibilities of top management for quality assurance.

ISO advises companies to inspect, revise, and boost their quality system for leading perfection in other non-production areas.

Alternatively, GMP is dedicated to guaranteeing the safety, security, durability, quality, traceability, recognition, and sterility of consumable goods. It is responsible for protecting the health and safety of consumers, especially patients from adverse reactions and other possible harms. By GMP guidelines, organizations are obligated to document their every manufacturing step.

GMP is more deeply concerned with product quality and gives more emphasis to standardized manufacturing practices.

Industrial Uses

Industrial Uses- Picture Courtesy: Moravek

ISO and GMP are widely diverse in their industrial applications. ISO is valid for every organization, whether production, healthcare, laboratories, construction, trade, or others, and is not unique to any facility or production line.

On the contrary, GMP protocols are exclusively implemented in industries- regulated by drug and food regulatory agencies, for instance, the medicinal, biotechnology, nutraceutical, veterinary, medical instruments, food, beverage, and, beauty industries.

Regulatory Requirement (Voluntary or Mandatory)

Regulatory Requirement- Picture Courtesy: Single Use Support

Acquiring the ISO certification is completely voluntary and organizations usually get a competitive edge over their competitors and customer trustworthiness by adhering to this certification.

It is noteworthy that there are no legal ramifications of not obtaining ISO certification. Still, for successfully operating an organization this certification is a must. The firms are free to adopt ISO regulations to show their clients that they are committed to quality.

However, laws and guidelines are an absolute must for pharmaceutical and food companies. The governing bodies, especially FDA and EMA dictate and review compliance with the GMP standards. GMP standards are enforced by law and are a must for production approval licenses. Companies must adhere to GMP to legitimately produce, market, and sell their consumable goods.

Certification vs Auditing

Certification vs Auditing- Picture Courtesy: PharmOut

Organizations interested in implementing ISO certification must undergo auditing through third-party bodies that are qualified to inspect and audit different patron businesses. ISO-accredited certification agencies measure performance compliance with ISO regulations. Moreover, these organizations are audited every year and are awarded ISO certification for three years between renewals.

FDA or EMA conducts annual inspections and reviews to ascertain GMP conformity. Moreover, they can reject or withdraw manufacturing permissions if guidelines are not implemented properly. The supervising bodies, found in almost every country across the globe, examine GMP adherence by regularly visiting facilities.

There are some harsh punishments and monetary penalties if GMP standards are not followed in the book.

Inspection Procedures

Inspection Procedures

FDA inspectors are allowed to review compliance with the newest or current regulations that are approved as required industrial procedures even though they are not specially mentioned in written guidelines. Conversely, ISO inspectors can only assess ISO compliance to the very last version of the ISO standard.

Scope

Scope

Scope- Picture Courtesy: CordenPharma

There are different variants of ISO and its scope is a lot broader than GMP. ISO 9001 usually accentuates quality management and quality assurance. ISO 14001 defines criteria for environmental management systems, while ISO 45001 deals with occupational health and safety management. Conversely, GMP envelops every facet of manufacturing, such as starting material, training, hygiene, facilities, equipment, and documentation.

Requisites

Requisites

ISO needs a management assessment review, quality strategy, quality guidelines, or quality auditing. It also defines a supplier assessment protocol or a procurement process. Opposingly, GMP mandates that buildings, warehouses, facilities, and equipment must adhere to strict regulations for size, cleaning and maintenance ease, sterility maintenance, ventilation, calibration, heating, cooling, electricity, plumbing, water treatment, sewage, and routine hygiene.

Quality Control

Quality Control

ISO does not overtly mandate the formation of a quality control unit, consigned with the power to accept or reject products. Instead, ISO urges businesses and companies to specify the roles and duties in quality management systems. It demands the appointment of management personnel who have the power to implement the standard.

Conversely, GMP specifies the need for the creation of quality control units with complete and absolute clout to accept or reject the product. It also defines the particular structure and responsibility of the quality control unit.

Documentation

Documentation

ISO usually necessitates a documented record of quality management systems, operational practices, and risk management strategies. Since GMP is more concerned with the implementation of quality requirements, it needs more thorough and stringent documentation, centering on batch records, SOPs, and product testing protocols.

4.How are ISO and GMP similar?

ISO and GMP concur on important points related to quality management. They both are designed to ascertain that products and processes fulfill required quality regulations. Some significant similarities between ISO and GMP are discussed below:

Simmilarities between ISO and GMP

Emphasis on Quality

Emphasis on Quality- Picture Courtesy: World Pharma Today

ISO 9001 and GMP are focused on quality. Both entail constant assessment to boost quality outcomes. They ensure the manufacturing of superior-quality goods. Consistent quality and operative fineness are their top priority. Both approaches are developed to prevent the errors in first place.

Record Keeping

Record Keeping

ISO and GMP heavily prioritize detailed and thorough documentation. They dictate the importance of comprehensive record-keeping for auditing, inspection, and, quality management. Correct records in ISO standards are essential for maintaining process consistency and continuous improvement. Whereas, in GMP, documentation plays an integral role in product traceability and is indispensable in quality control and accountability.

Continuous Improvement

Continuous Improvement

Both standards prescribe the need for incessant improvement in manufacturing and servicing Plan-Do-Check-Act (PDCA) cycle is vital to process improvement in ISO standards. It advises organizations to routinely evaluate and boost their processing quality.

On the other hand, continual improvement in the fulfillment of GMP quality requirements occurs through regular assessment, and CAPA (corrective and preventive actions).

Both ISO and GMP monitor unceasing quality enhancement by product testing, supplier auditing, process evaluation, product assessment, self-inspection, and addressing customer complaints.

Training

Training- Picture Courtesy: BiOZEEN

ISO and GMP dictate that employees and operators in facilities must be properly trained and equipped with the necessary skills to perform their duties capably. ISO regulations obligate that the workforce must be rightly qualified for the jobs they perform, which minimizes errors and boosts product quality. Similarly, GMP mandates operators must be trained so that they can learn about hygienic practices, contamination hazards, and their processing duties.

Auditing

Auditing- Picture Courtesy: TPA Group

It is mentioned in both ISO and GMP guidelines that organizations must carry out external and internal inspections to certify compliance with regulations. ISO inspections are performed by accredited organizations, whereas GMP inspections are conducted by regulatory agencies to evaluate safety and quality compliance.

5.What are the Benefits of Implementing ISO and GMP?

Implementing both ISO and GMP comes with numerous benefits, including enhanced quality assurance, regulatory conformity, customer satisfaction, and operational performance. Let’s detail the different advantages of adopting ISO and GMP in businesses:

Improved Quality and Safety

Improved Quality and Safety- Picture Courtesy: Sirocco Consulting

Implementing one or both of these industrial standards will lead to improved manufacturing quality. By complying with these standards, organizations are consistently boosting their operational, packing, and distribution excellence. Moreover, safe, pure, and potent pharmaceutical, medical, and, cosmetic products will be delivered to end-consumers by adhering to the strict specifications of ISO and GMP- related to manufacturing, handling, and, storage.

More Market Access

More Market Access

Adherence to these globally recognized standards means that companies follow best manufacturing practices and reduce manufacturing errors and deviations. This leads to a boost in customer trust and brand popularity. So, brands gain access to far and wide market areas and fulfill global trade requirements.

High Employee Competence

High Employee Competence

ISO and GMP stress the necessity of continuous employee training to promote quality awareness and hygienic practices in organizations. This creates a skilled batch of knowledgeable and committed workforce who always strive to uphold industrial standards, leading to increased workforce engagement and productivity.

Better Supply Chain Management

Better Supply Chain Management

Rigorous supplier assessment protocols by ISO ensure better quality and consistency of the supply chain. GMP mandates stringent quality controls on raw feed, procurement of equipment, and other parts. With both these standards, a strong and trustworthy supply chain is created, promoting optimized product quality, lowering disruptions of the supply chain, and decreasing the rate of ambiguous materials entering production facilities.

Waste Reduction

Waste Reduction

The basis of ISO 14001 lies in minimizing the environmental impact of processes by increasing resource use, decreasing waste, and augmenting energy consumption. Moreover, GMP controls also cut down resource and product wastage by reducing production anomalies, contamination, and, item recall. This implementation of both ISO and GMP results in green, eco-friendly, and cost-effective operations.

Safer Operational Environment

Safer Operational Environment

ISO standard is also related to minimal operational accidents and incidents, in turn improving the safety of the workplace. GMP stresses the importance of sterile, aseptic, and safe procedures to avert contamination and thus protect workers from health adversities. They both assist in establishing safe and compliant operational settings, safeguarding employees as well as the composition of products.

6.How can ISO Complement GMP?

Although ISO and GMP have somewhat diverse focus, employing them together is an intelligent approach. They both complement each other successfully in regulated industries, for instance, pharmaceutical, food, and healthcare.

Risk-Based Strategy

Risk-Based Strategy- Picture Courtesy: Stratex hub

GMP incorporates risk management strategies, for instance, detecting device failure and product flaws. In ISO, a structured approach is utilized to implement risk-based thinking across the whole organization. The latter urges firms and businesses to proactively detect hazards and opportunities in the operating processes, which complements the GMP approach of averting quality errors and deviations.

Customer Focus

Customer Focus- Picture Courtesy: Medium

ISO strongly emphasizes learning and fulfilling customer requirements. Incorporating customer-centric principles into GMP regulations urges companies to take into account regulatory compliance and the needs of end-consumers.

Thus, by associating manufacturing processes with consumers' needs, GMP can concentrate on product quality, strength, and safety that directly fulfill or surpass customer expectations. It can result in the creation of customer-compliant goods that reverberate well with consumers, boosting their trust and loyalty.

Organization Efficiency

Organization Efficiency

The focus on GMP lies on the practical aspect of product engineering, whereas, ISO considers a methodical approach to improve the efficiency of organizations and non-production procedures, for instance, buying, sales, and customer support.

Therefore, by incorporating ISO process improvement with GMP standards a stronger regulatory framework is created, which boosts product quality, manufacturing efficiency, and risk management approaches, and cuts redundancies.

Conclusion

In conclusion, the ISO and GMP are two distinct standards with diverse scope, purpose, focus, regulatory requirements, and, auditing processes. ISO is more process-centric while GMP is more product-centric. However, the end goal of both these regulations is to ensure better and enhanced product quality. The anticipated advantages of effectively integrating these regulations are huge in terms of return on investment. By implementing these standards in harmony, you can achieve superior-quality products, decrease product shortages, reduce validation and documentation, and rapidly deliver more products to market. For more details and queries regarding differences between ISO and GMP, you are encouraged to contact Allpack customer care.

Don't forget to share this post!

CONTACT US

Tell us your raw material and project budget to get quotations within 24 hours.

WhatsApp Us: +86 181 7101 8586

The Buyer's Guide

Want to get Best Price Viscosity Tester from China?

Tell us your material or budget, we'll reply you ASAP within 24 hours

ISO VS GMP Read More »

Ribbon Dryer: The Complete Buying Guide In 2025

Pharmaceutical Dryer

Ribbon Dryer: The Complete Buying Guide In 2025

How do you dry heat-sensitive materials? Modern sciences and technology have come with advanced techniques and methods to complete such challenging tasks safely. Today, ribbon dryers serve as the most optimal drying equipment to subject materials to various drying temperatures. If you’re planning to bring this unit to your working facility; then don’t go anywhere. This informative and knowledgeable post is just designed for you.

Here you can find out about the significance, uses, working, structure, and related technical problems with easy troubleshooting, and much more. Stay with us and read the blog.

Add a header to begin generating the table of contents

1.What is theribbon dryer?

Ribbon Dryer- Picture Courtesy: Wanda

A ribbon dryer is a highly renowned industrial equipment, employed for specialized applications of mixing and drying. Due to its effortless combination of blending and drying in one machine, it is considered an ideal tool for processing thermosensitive or oxygen-sensitive materials, such as granules, crystalline materials, low-viscosity pastes, and powders.

The ribbon dryer has a jacketed cylindrical shell with specialized helical agitators for even heat distribution and constant and gentle stirring of materials. The mixing action initiated by agitators continuously results in the moving of fresh layers of materials toward the heated walls of the shell.

2.How a ribbon dryer is significant for your business?

A ribbon dryer is a multi-functional machine, regarded as a mixing and drying powerhouse in the manufacturing sectors. It comes with a limitless list of unique benefits for your business. Let’s dig into the significance of a ribbon dryer:

Increased Efficiency and Productivity

Increased Efficiency and Productivity- Picture Courtesy: Andreotti Farmaceutica

A ribbon dryer is preferred in different manufacturing units because of its absolute best efficiency and productivity. This device is not only capable of drying large batches of materials but also has the shortest drying cycle. Moreover, by attaining blending and drying in a single device, the ribbon dryer streamlines the manufacturing process, which saves both resources and time.

Durable and Hygienic Design

Durable and Hygienic Design- Picture Courtesy: Scott Equipment Company

This machine is manufactured with durable, long-lasting, and, superior-quality stainless steel and is available in all types of sizes- from laboratory to industrial scale. The drives, motors, and bearings are fitted outside the drying vessel and hence are not exposed to high temperatures as the feed is being dried. This increases the convenience of lubricating, maintaining, and drying machines.

Gentle Drying

Gentle Drying- Picture Courtesy: Ecco Verde

The agitators in the ribbon dryer gently distribute the materials inside the drying vessel and thus the feed is not subjected to damaging frictional forces or other deteriorating conditions. Therefore, industries and productions use this drying machine for processing materials that cannot tolerate excessive heat or mechanical stress. It is necessary for handling fragile powders, active drug components, and fabrics.

Uniform Blending and Drying

Uniform Blending and Drying- Picture Courtesy: IVC Journal

The ribbon dryer is designed with sturdy helical ribbons that force feed to and fro for mixing. The ribbons present at the outer edge move feed towards the center of the drying chamber from the outer edges, while the inner ribbons displace the feed from the center towards the outer edge, resulting in better homogeneity and drying.

Increased Energy Efficiency

Increased Energy Efficiency- Picture Courtesy: Chemical Processing

A ribbon dryer is utilized for direct as well as indirect heating, leading to efficient use of energy depending upon the feed and drying needs. Indirect heating is ideal for efficiently drying the material, lowering heat loss, and conserving energy utility. This feature is integral in productions where energy expenses consume a huge chunk of utility bills.

Decreased Product Wastage

Decreased Product Wastage- Picture Courtesy: PacMoore

Since the ribbon dryer upholds a controlled drying environment in the drying chamber, therefore; there is less likelihood of overheating or degrading the product. This causes minimal wastage of starting material in turn leading to higher throughput. This benefit is especially pivotal in settings where raw feed or active ingredients are expensive.

3.Where is a ribbon dryer mostly employed?

There has been a significant revolution in drying technology, especially where a ribbon dryer is concerned. Due to fast, consistent, and, gently drying approaches, this machine occupies a special place in wide-ranging industries. We are discussing different industrial sectors where a ribbon dryer has found its use for your information:

Pharmaceutical Industry

Capsules and Powder- Picture Courtesy: Biopelle

The pharmaceutical industry often processes delicate and fragile materials, requiring extremely gentle processing devices, one of which is a ribbon dryer. It gradually dries various sensitive pharmaceutical ingredients and other compounds without causing a loss of their structural integrity. It is typically used after wet granulation or in other mixing processes to produce high-quality granules and powders.

Food Industry

Food Industry- Picture Courtesy: The Lantern

In the food industry, different types of food materials like pastes, soups, and doughs are consistently mixed and require efficient drying. Hence, a ribbon dryer is ideal for blending and drying applications in the food industry. It is involved in the drying of spices, herbs, flavoring agents, juice mixes, coffee, and tea mixtures.

Chemical Industry

Paint Pigments- Picture Courtesy: Hockmeyer

The function of a ribbon dryer in the chemical industry is to uniformly reduce the moisture content of different chemicals, for instance, resins, polymers, pigments, and dyes for optimized processing or packaging. It also has a role in the successful and thorough drying of various chemicals, such as catalysts and metals involved in different chemical reactions.

Cosmetic Industry

Cosmetics

A wide range of delicate powders and pastes are frequently processed in the cosmetic industry to manufacture high-quality beauty clays, face masks, talcum powders, foundations, blushes, and other shades. So, a ribbon blender is an appropriate device to smoothly mix and dry sensitive powders and granules without damaging their properties and forms.

Agriculture Industry

Agriculture Fertilizer

Different types of organic and inorganic fertilizers, feeds, additives, and other agricultural compounds are rich in moisture and must be properly dried for effective granulation and storage. Therefore, a ribbon dryer is one of the highly utilized drying machines involved in moisture control in the agriculture industry.

Textile Industry

Textile Industry

A ribbon dryer has also found its way into the textile industry for meticulous and uniform drying of various powdered dyes, treatments, and fabric additives. This machine is typically preferred in the precise processing of fabrics because it removes every moisture particle from the textile powders, leaving them fully dried and undamaged.

4.What are the available types of ribbon dryers?

A ribbon dryer is categorized into various groups depending on its structure and orientation. Let’s go into details of the classification of a ribbon dryer:

According to Orientation

Two kinds are available in the market based on the orientation of a ribbon dryer:

Horizontal or U-Shaped Trough Ribbon Dryer

Horizontal Ribbon Dryer

This ribbon dryer is horizontally oriented with a horizontally located shaft. It has a cylindrical or U-shaped trough design and is appropriate for materials that are distributed across a wide plane for consistent drying. In a horizontal ribbon dryer, a spiral flow of feed is formed because of the rotation of ribbon blades. The feed is transferred in lateral and radial directions, resulting in countercurrent mixing action.

It is appropriate for free-flowing powders and semi-dry pastes. It offers a large surface area for heat distribution, enhancing drying rates.

Vertical Ribbon Dryer

Vertical Ribbon Dryer- Picture Courtesy: PerMix

This machine is vertically configured with a shaft fixed vertically within a tall conical screw-shaped chamber. This makes the arrangement of the vertical ribbon dryer more compact, reducing its floor print. Materials are fluidized in a vertical upward direction, resembling a vortex, and with gravity, these materials are dropped down. So, a vertical ribbon dryer is ideal for heavier viscous materials that require longer retention time.

It has less surface area for drying and the heat transference happens by the contact with walls of the drying chamber, thus having slower drying.

According to the Number of Shafts

There are the following subclasses of a ribbon dryer based on the number of shafts:

Single-shaft Ribbon Dryer

Single-shaft Ribbon Dryer- Picture Courtesy: SIEHE Group

In this type of ribbon dryer, only one rotating shaft equipped with ribbon helical blades is present. The ribbon-like structures rotate along the length of a drying chamber and move the material only in one direction, providing a moderate level of agitation and drying.

It is generally utilized for small and simpler drying tasks because it does not offer the intense stirring required for breaking hard lumps and agglomerates. It has straightforward construction and is a cost-cutting choice for small and medium-scale productions.

Double-Shaft or Double Ribbon Agitator Dryer

Double-shaft Ribbon Dryer- Picture Courtesy: SIEHE Group

The core component in this kind of ribbon dryer consists of two parallel ribbon blades, rotating in opposing directions, thereby resulting in strong and intense intermingling and drying action.

These double shafts are well-known for their improved mixing throughput, causing a complicated pattern of lifting, folding, and, agitating. This leads to better exposure of feed to drying vessels and improves consistency in drying rates.

It can easily process thick, sticky, and viscous materials as compared to its single-shaft counterpart. It is generally involved in bulk volume processing and faster drying rates.

Triple-shaft Ribbon Dryer

Triple-shaft Ribbon Dryer- Picture Courtesy: Phoenix Equipment

The central part of the triple-shaft ribbon dryer has three parallel shafts (one inner, one in the center, and one at the outer edge), offering more intricate and intense blending and drying action. These shafts have their rotational directions, contributing to increased contact between the heating source and starting material.

There is no dead zone in the triple-shaft ribbon dryer, thus it is highly suitable for difficult-to-handle, extremely dense, and viscous slurries and pastes. However, it is a costly device that consumes more energy for its operations.

Hybrid Paddle Ribbon Dryer

Hybrid Paddle Ribbon Dryer- Picture Courtesy: Marion Solution

It is composed of the combined action of the agitator and agitating paddles simultaneously. It creates the reversal mixing and drying effects there materials form an even movement and subtle drying.

Here, you must know how to utilize the correct selection when it comes to addressing the agitator and knowing the drying time. Hence it assures the optimized and correct discharging of materials.

5.What is the structural framework of the ribbon dryer?

A ribbon dryer is comprised of a jacketed shell and uniquely engineered ribbon agitators; used for dispersing feed and vaporization moisture. Several important components work in conjunction to optimize drying time and heat distribution. Some of the fundamental parts of a ribbon dryer are detailed below:

Parts of a Ribbon Dryer

Feed Port	The feed for drying is loaded from the feed port found at the upper portion of the drying chamber. This port is manually controlled or attached to the automatic conveyor for consistent feed dispensing.
Shaft	It is a rotating, horizontal, or vertical rod fixed in the middle of the drying chamber. It is manufactured using strong and temperature-resistant to increase its lifespan. This part rotates with the help of power provided by the motor and gearbox.
Drying Chamber	It is also called a shell or barrel and is created using durable and corrosion-resistant materials, for instance, stainless steel, carbon steel, etc. to be impervious to increased temperatures, pressure, and, chemicals. In most of the cases, it is horizontal and cylindrical. In this chamber, rotating shafts and helical ribbons are mounted to dry feeds.
Helical Ribbon	Helical or ribbon-like blades are attached to the shaft, which usually resembles a double helix. Their function is to disperse the feed along the entire space of the drying chamber. They offer continuous mixing and force materials in opposing directions- towards the edges and middle for thorough mixing.
Discharge Port	It is usually located at the bottom part of the drying vessel for easy discharge of dried materials. It is offered with a mechanical or automatic valve or gate to regulate the release of feed.
Motor/Drive	Drive assembly consists of a motor and gearbox and is essential in providing mechanical power to the shaft for its rotation. The motor is present at the end of the drying barrel. The drive assembly is responsible for controlling the speed and torque of the shaft.
Packing Gland Seal	It is a mechanical seal, mounted on the ribbon dryer to ensure there would be no leakage of liquids from the machine. It is present at the conjunction of shaft and covering. It is designed to act as a barrier to prevent the escape of feed when the shaft is rotating.
Cover/Lid	The cover or lid is a safety feature that airtightly seals the drying chamber to keep the inner feed in isolation from external agents. It is known for upholding consistent drying conditions inside the chamber.
Vent Port	It is also termed an exhaust system and its job is to unload vapors from the drying chamber. This vent port is equipped with different types of airflow controls, dampers, and other filters to regulate airflow.

6.What is the difference between a ribbon dryer and a tray dryer?

A ribbon dryer and a tray dryer are both pharmaceutical dryers but the difference lies in their design, drying mechanism, and drying rates. Here are a few fundamental differences between these two machines:

Ribbon Dryer	Tray Dryer
It is comprised of a horizontal or vertical drying vessel with rotating shafts and helical ribbons.	It is featured with numerous trays stacked on top of each other in a drying vessel.
The drying is based on the conductive and connective principle in a ribbon dryer.	Its drying mechanism is based on the convective principle.
It is appropriate for powders, granules, pastes, and viscous feed.	It is ideal for drying herbs, fruits, and, pharmaceutical products.
It performs both mixing and drying functions.	It only dries the feed.
It has high drying potential because of the mixing actions of ribbon blades that consistently agitate materials, leading to rapid drying rates.	The drying takes more time because air circulates in the dryer while the material is static.

7.What are the cleaning and maintenance principles of a ribbon dryer?

Cleaning and Maintenance of a Ribbon Dryer- Picture Courtesy: IronPlanet

The cleaning and maintenance of a ribbon dryer is strongly correlated with outclass performance, product quality, and durability of the machine. So, let’s learn about key points of cleaning and maintenance of a ribbon dryer:

Clean-in-Place System	Many industries have set up CIP systems to efficiently clean the ribbon dryer without going for lengthy and exhausting disassembly. It circulates various types of cleaning agents, for instance, detergents, disinfectants, bleach, or water to completely clean the ribbon dryer.
Regular and Deep Cleaning	It is advised to clean the machine after every processing batch or after the processing cycle to get rid of material accumulation or cross-contamination. Moreover, deep cleaning of a ribbon dryer should be performed every week to remove adhesives, oils, or powders. You must remove each part and thoroughly rinse them with water jets, or chemical agents. It is essential to clean and scrub important components, for example, ribbon blades, shafts, chamber walls, and discharge ports.
Inspection	Frequently check important parts for damage, rusting, corrosion, and wear and tear. Inspect ambiguous vibrations, noises, or feed leaks from the machine. Proper heat transfer must be ensured by inspecting the functioning of the heating and ventilation system. Predictive maintenance is performed using various thermocouples and IoT sensors to proactively repair components.
Lubrication	Bearing, shafts, and seals should be routinely lubricated with the right kind of lubricant, for instance, grease or oil to avert overheating and frequent wear and tear.
Alignment	If ribbons or shafts are not properly aligned, it could result in poor drying or a high rate of component damage. Therefore, inspect and fix the issues in alignment of rotating components.
Calibration	It is important to calibrate temperature, pressure, airflow, and moisture sensors on a routine basis to ensure accurate management of drying efficiency and performance.

8.What are the common problems and solutions of a ribbon dryer?

The problems in a ribbon dryer are commonly associated with mechanical working, processing, and material inconsistencies. But with proper maintenance, supervision, and operator training, these problems are easily rectified. So, let’s discuss common problems and solutions for a ribbon dryer:

Nonuniformities in Drying

Nonuniformities in Drying- Picture Courtesy: GIMAT Srl

After drying, it is discovered that some parts of the feed are over-dried while in others, a significant amount of moisture is present. This results in inconsistencies in drying.

Causes

There are a large number of reasons for this problem, such as poor mixing because of old, damaged, or misaligned ribbon blades. There is inaccurate heating or inadequate airflow inside the drying vessel. The materials are loaded wrongly in the dryer or the shaft has incorrect rotational speed.

Solutions

The solutions to this problem are routine examination and maintenance of the ribbon blades to identify and repair their wear and tear. Also, correct leveling and alignment of the blades. Secondly, check the working of the heater and ventilation system to ascertain the correct heat distribution in the drying chamber. You should fix the airflow in the chamber to boost heat absorbance. Alter the rotational speed and feed rate to attain equivalence between material load and drying.

High Energy Use

High Energy Use- Picture Courtesy: MC2 srl

Sometimes, the ribbon dryer uses more energy than calculated, resulting in more operational expenses.

Causes

The reasons for this issue are: loading of ribbon dryer well above the working capacity. There is inadequate insulation or a leak in a ribbon dryer, promoting heat wastage. Also, you are operating the device at an excessive temperature than required.

Solutions

To solve this issue, you must not overload the ribbon dryer and ensure its loading capacity is under the working limit. Properly and regularly examine the machine to identify the leaks in the machine cover, gaskets, and seals. Fix these perforations to increase thermal throughput. Recalculate the drying temperature and maintain this temperature when drying.

Clogging of Material

Clogging of Material- Picture Courtesy: WAMGROUP

The material accumulates inside the dryer, particularly around edges, walls, blades, or at the periphery of the discharge port. This results in poor drying and uneven mixing.

Causes

It is due to sticky and extremely viscous residues that incline to stick on surfaces. The design of the ribbon blade also leads to inadequate mixing or agitation.

Solution

To address this issue, the ribbon blades must be compatible with the type of material being dried. Secondly, use specialized coating agents or non-stick components to prevent the sticking of viscous substances. It is suggested to increase the speed of the shaft to improve material fluidity. Also, maintain a regular cleaning schedule to decrease material accumulation.

Leakage from the Seals

Leakage from the Seals- Picture Courtesy: ROSS Mixers

In certain cases, different kinds of substances, such as air, vapor, or feed leak from seals or covers, minimizing drying throughput.

Causes

This issue is because of degraded packing seals and poorly secured covering of a ribbon dryer.

Solutions

It is advised to frequently examine and replace the worn-out packing gland seal to decrease the frequency of leakage. Moreover, properly secure the cover and lid to maintain airtight sealing.

Slow Discharge

Slow Discharge- Picture Courtesy: CMT Process Solutions

The products are improperly unloaded from the outlet, leading to slow processing capacity or machine halting.

Causes

There are various reasons for this issue like material accumulation near the discharge port. Furthermore, inefficient ribbon blade configuration also contributes to poor product fluidity.

Solutions

To solve this problem, one must routinely clean the entire machine, especially around the discharge vent. Alter the ribbon blade design to enhance material fluidity from the discharge port.

9.What is the prospect of a ribbon dryer?

Future Prospects of Ribbon Dryer

The future progressions are closely associated with technological evolutions, changing industrial requirements, and, environmental deliberations. As industries are in the process of continuous revolution, so demand for efficient ribbon dryers is on the steady rise.

It is stipulated that with stricter environmental regulations, industries are committed to driving down their energy consumption, hence, in the future, ribbon dryers will have improved heat distribution designs like optimized insulation, and enhanced blade arrangement to cut down energy use and increase drying rate.

Furthermore, efforts have been made to increase automation of the ribbon dryer with the integration of IoT (Internet of Things), and smart sensors to transform the efficiency of drying procedures and improve real-time supervision, predictive maintenance, and timely setting of operational parameters. The ribbon dryer of the future will have intelligent control systems to provide ease to operators in adjusting drying parameters.

This automation will contribute to better regulation of temperature, airflow, and drying speed, leading to improvement in product quality while lowering interruption and maintenance expenses.

Conclusion

In conclusion, a ribbon dryer is the perfect choice of drying device for various manufacturing sectors to optimize drying performance, time, and energy efficiency. It has multi-functional potential and versatility justifying the drying requirements and moisture control demands in different industries. It is involved in better heat transfer, leading to a short drying cycle and minimizing energy bills. The ribbon dryer boosts the consistencies in drying rates, thus resulting in more return profits for businesses. If you want a customized machine well-matched to the capabilities of your production, then you are encouraged to contact Allpack for the best guidance and support.

Don't forget to share this post!

CONTACT US

Tell us your raw material and project budget to get quotations within 24 hours.

WhatsApp Us: +86 181 7101 8586

The Buyer's Guide

Want to get Best Price Ribbon Dryer from China?

Tell us your material or budget, we'll reply you ASAP within 24 hours

Ribbon Dryer: The Complete Buying Guide In 2025 Read More »

Vacuum Dryer: The Complete Buying Guide In 2025

Pharmaceutical Dryer

Vacuum Dryer: The Complete Buying Guide In 2025

Have you ever wondered how to sustain product quality when drying? You must be well aware of the demerits of conventional drying methods. Now, many of the old drying methods are obsolete. Because it can bring drying with compromised product quality.

A vacuum dryer is the solution to preserve the potency of your materials by subtly evaporating unwanted moisture. This blog is all about the vacuum dryer and extensive knowledge that you must know.

Whether you are a researcher, pharmacist, biotechnologist, technologist, or businessperson. This is the right place for you. Why? Here you can find A to Z information hooked to this equipment. Without wasting your time, let's jump into the main subject.

Add a header to begin generating the table of contents

1.What is a vacuum dryer?

Vacuum Dryer

The vacuum dryer the suitable unit used for various batch processes to minimize the pressure of air. By reducing pressure directly lowers down the boiling point of the water.

Ultimately, the presence of moisture in the particles goes out and makes your content evenly dried. The machine is highly recommended for ingredients those are very sensitive to heat.

However, machine follows the subtle principles to maintain the potency of the products. Such as, inducing the heat which dried the content at a lower temperature. The vacuum itself is responsible for removal of air and moisture content. That’s why it is mainly responsible for the drying of heat sensitive materials.

2.What are the benefits of a vacuum dryer?

A vacuum dryer is considered as a quiet reliable unit for the drying process and has been utilized for a longer period of time. All due to their various benefits it is offering to their customers. That’s the reason, pharma, foods, biotechnology and various fields require it for attaining safe drying procedure. have a look at below discussed important advantages offered by a vacuum dryer.

Less Energy Expenditure More Drying

Energy Conservation- Picture Courtesy: Inspired Ingredients

Do you know that energy conservation is the biggest advantage of vacuum drying? This is true, you need less amount of energy which directly shortens your economic expenditures required for the drying process.

The vacuum dryer tends to make the drying process very fast therefore cutting down the time required for the drying of moisture present in the product.

Safe for your Ingredients

Preservation of ingredients

This is the second most important benefit of using a vacuum dryer where your ingredients are meant to be safe when it comes to dealing with this unit. This is pretty normal that some materials may be capable of experiencing high temperatures, but some do not.

This is nothing to worry about as a vacuum dryer is a reliable machine that helps in maintaining the integrity of the content without harming their qualities. That’s why pharma, foods, nutraceuticals, and many other facilities prefer vacuum dryer for drying procedures.

Secure for your Workers

Vacuum Dryer

If you see other kinds of dryers, they are constructed in a way that gives off fumes from vented parts. The generation of those particles in your environment makes the workers sick and also affects the working facilities. The vacuum dryer in this way is safer as it is capable of capturing the moisture in the collector with the help of a condenser and removed by using a vacuum pump.

High Productivity

Greater Production- Picture Courtesy: EnWave Corporation

As compared to traditional or direct modes of drying the contents, the vacuum dryer offers you greater production capacity. This is because the drying efficiency of the machine is so fast. It lowers the boiling point and induces the vacuum which offers a faster drying. You can enjoy maximum production capacity due to its rapid drying time.

Excellent Automation

Vacuum Dryer with Excellent Automation- Picture Courtesy: Amixon GmbH

The vacuum dryer is mainly designed with automatic keys which are features with auto-sensor, temperature regulator, induction of vacuum, drying time, etc.

With so many properties, you do not need to stand all the time to monitor the process. Similarly, as machine senses the temperatures, reduces the insight pressure, and develops a vacuum, with automatic time which is already fed in before starting the procedure.

So, with these features, you can only introduce the materials to be dried and start the machine, further operation will be performed by the machine automatically.

No More Chemical Reaction

Product’s Integrity- Picture Courtesy: Busch Australia

When you’re using a vacuum dryer, you will have greater control over the parameters inside the vacuum chamber. For example, you have controlled variables such as temperature and pressure. This means it can help in the prevention of chemical reactions happening inside. For example, there’s no chance of oxidation with certain medicines when encountered with a vacuum dryer.

Due to the vacuum, you can provide a gentle way of drying hence well-controlled process can be achieved without interrupting the content or substances with powdered texture.

3.What are the applications of vacuum dryer?

A vacuum dryer is widely utilized in the broad industrial sector as it offers you various distinguishing benefits. Let’s see the industrial applications of vacuum dryers.

Food Industry

Food industry- Picture Courtesy: Avid Armor

In the food industry, there are several goods prepared that are dried by vacuum dryer to preserve their potency freshness, effectiveness, and aroma. When you are subjecting them to a conventional dryer, there might be a greater possibility of damaging all the above properties of your food. Thus, vacuum dryer makes consumers appeal and efficacy of foods.

There are various nutritional ingredients such as spices, dried foods, snacks, coffee, powdered milk, tea, and various dried products such as pulses, grains, etc are dried by this unit which lowers the presence of water level by reducing the pressure and boiling point of water. Thus, more safe drying is achieved.

Pharmaceutical Industry

Pharmaceutical Industry- Scenesafe

When drugs have moisture content, it has more chance to be oxidized. In the pharmaceutical industry, no one can ignore the significance of vacuum dryers. Because it helps in the drying of drugs and medicines without affecting their therapeutic activities.

As medicines are mainly required for the treatment of various ailments therefore to prepare them under control conditions is mandatory and it must be promising in terms of treatment.

This is mainly used in the manufacturing of medicines to have them with stable shelf life, possessing greater integrity and high potency. For example, preparation of antibiotics, powder suspension, dry powders for topical preparations, etc.

Biotechnology

Biotechnology- Picture Courtesy: Boniik

This is a sensitive and complex field where advanced ways are applied to biological systems to bring new fruitful products. Various elements such as proteins, enzymes, microbiological assays, yeast, amino acids, and macroscopic as well as microscopic studies are carried out.

For this purpose, this sector is always installed with a vacuum dryer to achieve safe and desirable outcomes.

Research and Development

Research and development- Picture Courtesy: Vetoquinol Australia

In research and development, a vacuum dryer has been hooked to broad applications. It dries the assay powders and sensitive elements of research studies-controlled environment. Hence it supports the research assays by preserving the quality of the goods. For example, drying of raw materials, isolation of powders, antibiotics, various animal and herb samples, macroscopic and microscopic samples, etc to preserve them safely for a certain period of time.

Chemical Industry

Chemical Industry- picture Courtesy: EY

You can dry various chemicals whether it is heat-sensitive, non-heat-sensitive, reactive, or non-reactive by using a vacuum dryer. This machine ensures that chemicals are dried without interfering with their properties or affecting the characteristics of items. It ensures that unwanted chemical degradation or reaction is less likely to occur, and your product is kept preventive and can be released from the machine with the same intact properties.

Agriculture Industry

Agriculture Industry- Picture Courtesy: Crop Science Society of America

A vacuum dryer is used in the agricultural industry when drying the crops after washing and making them cleaned and entirely dried. This is required to increase the shelf life of agricultural products by maintaining their nutritional value and essential properties.

You can employ them in the preservation of seeds and may use them during breeding periods to get effective germination and extensive crop growth. Moreover, for the herb’s extraction in the agricultural field, a vacuum dryer is required to improve the extraction and good quality extraction.

4.What is the construction of a vacuum dryer?

Parts of Vacuum Dryer

The parts and description are mentioned in the given table.

Parts	Description
Door Gasket	A silicon or rubber-made door gasket is an important part of a vacuum dryer. The purpose of this specialized door is to attain an airtight sealing. When it is closed firmly, the possibility of achieving a vacuum is way faster. The outside air won’t be able to enter the unit so you can achieve the required drying rapidly.
Vacuum Gauge	The purpose of a vacuum gauge is to display the particular pressure gauge. You can easily determine the real-time measurements present inside the vacuum chamber.
Control Panel	You can control various characteristics such as vacuum pressure, drying time, temperature regulation, run time, troubleshooting, and other programmable settings are optimized by using a control panel.
Switches	Switches significantly enable you to operate the machine. They are simple and highly protective in terms of operation. You can turn the ON and OFF the machine with the help of switch regulations.
Valve	The regulation of airflow inside and outside the system is carried out by the help of valves. The proper working of valves ensures that the system is working effectively and the unit is safe without risks of contamination.
Observation Window	The glass window is mainly made up of transparent materials ensuring you monitor what’s going on inside. Here you don’t need to open and close the window again and again hence the vacuum condition becomes stable.
Shelf	You can place materials to be dried on the shelves. These are mainly perforated in design with stainless steel corrosion-free materials that ensure a safe and uniform airflow inside the chamber. Therefore, the number of items arranged on the trays or shelves receives maximum time and treatment to get sufficient air drying.
Handle	This is a pretty common part of the machine that allows you to open and close the gasket door conveniently. The handles are designed with a firm twisting mechanism that ensures an airtight closing of the door.

5.What is the working of a vacuum dryer?

Working Principle of Vacuum Dryer

Process Steps of Vacuum Dryer

Step 1

As the chamber of the vacuum dryer is categorized with multiple shelves, therefore, you can simply place the sample to be dried over them. The basic working principle of the vacuum chamber is based on the induction of a vacuum. So, once you close the door tightly. The following process starts by simply starting the key on the control panel.

Step 2

The made up of vacuum dryer is associated with a vacuum pump which helps in the lowering of pressure inside. Also, the machine is integrated with a condenser which mainly supports your content from moisture as it evaporates effectively.

The typical range for vacuum pressure lies between 30 to 60 Kpa. This is mainly achieved by the utilization of vacuum pumps.

Moreover, the steam inside the chamber is evenly distributed via conduction. In this state, the water molecules evaporate quickly. The optimum temperature used is around 25-30°C.

Upon generation of vacuum, the process of vaporization becomes faster with simultaneous heat conduction which helps in the evaporation of water or moisture content. They’re mainly removed from the vacuum pump to avoid being transformed back thus you can get sufficient drying.

Step 3

After vacuum drying, your materials are cooled down. After achieving certain stabilization, you can carefully collect the materials from the shelves.

6.What is the classification of a vacuum dryer?

There are certain types of vacuum dryer. Let’s see them below:

Benchtop Vacuum Dryer

Benchtop vacuum dryer- Picture Courtesy: NBchao.com

This is commonly known as a lab vacuum dryer or static vacuum dryer. In this machine, uniform heat conductivity is generated and supplied over various shelves.

The process of drying for thick or viscous materials is a bit slow; it is because vacuum drying is not accompanied by agitation.

There are various examples of benchtop or lab vacuum dryer. For example, tray lab vacuum dryer, shelf vacuum dryer, and microwave vacuum dryer.

Tumbling Vacuum Dryer

AIPAK Tumbling Vacuum Dryer

It is another primary kind of vacuum dryer. Since it employs the rotating or agitating drum or vessel, it is also called a rotary vacuum dryer. The materials rotate in the vessel in the vacuum condition. The products are continuously exposed to high temperatures due to the rotation of the vessel, leading to faster drying times.

Variances in moisture retention are minimized due to constant rotational motion, which improves uniform material drying. Furthermore, it can treat bulk volumes of products and thus is more suited to mass-scale manufacturing. But it is less ideal for processing fragile products, as it degrades them. Its subcategories are:

Double Cone Rotary Vacuum Dryer

Allpack Double Cone Rotary Vacuum Dryer

A double-cone rotary vacuum dryer is an ideal solution for pulp, viscous, and thermolabile content which is mainly dried under low temperatures. The machine is capable of dealing with high-capacity content and materials prone get oxidized rapidly. This controlled unit, it can handle products without harming the integrity of raw materials.

Vacuum Pan Dryer

Vacuum Pan Dryer- Picture Courtesy: Heinkel

It is the form of a vacuum dryer in which heat-sensitive, pasty, and viscous products are heated more quickly with the aid of axial and radial agitators. It consists of a circular pan that offers a flat surface for even distribution of materials. This pan can be turned or rotated to speed up the drying process.

Vacuum pan dryer has the shortest drying cycle and produces even mixing without any lumps or balls due to its constant agitating movement.

Spherical Vacuum Dryer

Spherical vacuum dryer- Picture Courtesy: gmmpfaudler

The machine is designed with a hollow heated vessel with a jacketed wall. The presence of a rotating agitator ensures materials' uniform drying throughout the process. The spherical disc helps in the quick opening and closing of the system of charge and discharging of content.

Conical Vacuum Dryer

Conical Vacuum Dryer- Picture Courtesy: Hosokawa micron

The conical vacuum dryer mainly utilizes convection mixing for the drying. The constant rotation of the mixer ensures convective forces inside the conical vessel. For the drying procedure heat energy is required which is transferred into the vessel via a jacketed vessel that is induced by either hot air, water, or other media.

The presence of a vacuum ensures the elimination of vapors at a very low temperature that’s why it is known as an ideal solution for thermolabile products.

Horizontal Vacuum Dryer

Vacuum Belt Dryer- Picture Courtesy: Bucher Unipektin

This vacuum dryer is equipped with a conveyor belt that aids in homogenous drying. This belt conveys samples through various heating zones and a cooling zone in the vacuum chamber. The heat is administered from above or below the belt. The materials are placed on the parallel running belts. It has a design like an industrial boiler or a silo.

The vacuum belts have a direct connection with the heating and cooling plates, so, they directly transfer heat for drying products. Its drying temperature is about 35℃-90℃ and vacuum pressure is approximately 10mbar to around 80mbar.

Vertical Vacuum Dryer

Vertical Vacuum Dryer- Picture Courtesy: HEINKEL Group

It is identical in construction to a rotary vacuum dryer, except it has a vertical configuration with a conical bottom structure. This part is advantageous because of its minimal footprint, complete product discharge with lesser holdup, and easy cleanability. It also has an agitator that thoroughly mixes and dries while preventing lumping and caking.

It can accommodate about 25-13,000 liters of product while its drying temperature is about -10 to 150°C.

7.Can a vacuum dryer be suitable for dusty or hygroscopic materials?

Hygroscopic Materials

Yes, why not? A vacuum dryer is considered to be the safest unit for the drying of content those are hygroscopic or dusty in nature. Conversely, using hot air dry can affect the integrity of thermolabile and hygroscopic materials.

Therefore, a vacuum dryer is suitable as it mainly works under low pressure and reduced temperature which is a good option for heat-sensitive and hygroscopic goods. A vacuum dryer is demonstrated to show a greater rehydration rate than a conventional way of drying.

Therefore, this is the only option for manufacturing and other fields to use for the drying of hygroscopic materials, glutinous, or lumpy materials.

8.Is a vacuum dryer the same as a freeze dryer?

Vacuum Dryer- Picture Courtesy: Green Thumb Depot

Vacuum dryers and freeze dryers are different from each other. Generally, vacuum dryers and freeze dryers are applied in de-moisturizing processes within industries, but they operate on fundamentally different principles. Knowing the difference between them will guide you on which of the two is best for your case.
Here is a short comparison of vacuum dryers versus freeze dryers on key aspects:

Drying Mechanism

Mechanism

Vacuum Dryer	Freeze Dryer
It operates on the principle of a low-pressure environment that creates a reduced boiling point for water.	It uses the lyophilization process. Material is frozen, then pressure is decreased enough that the ice sublimates directly into vapor without going through the liquid phase.

Temperature and Pressure

Freeze Dryer (Temperature-40 to -80) - Picture Courtesy: Barnalab

Vacuum Dryer	Freeze Dryer
It is mainly operated at mild temperature range i.e. 40°C - 100°C.	It works at very low temperatures, sometimes between -40 and -80 degrees Celsius, and very high vacuum conditions.

Drying Time

Shorter Drying Time in Vacuum Dryer-Picture Courtesy: Waldner

Vacuum Dryer	Freeze Dryer
Vacuum dryer has a relatively fast drying cycle, in the order of minutes or hours depending on the material and the level of moisture.	Freeze dryer requires hours to days, and every step includes freezing, sublimation, and the final drying, which require careful handling.

Energy Consumption

Freeze Dryer- Energy Intensive – Picture Courtesy: Senieer

Vacuum Dryer	Freeze Dryer
It is regarded as more energy-efficient energy because it operates at intermediate temperatures and needs only a vacuum pump to maintain reduced pressure.	Freeze drying requires much energy as it involves working under low temperatures and maintaining refrigeration and a vacuum.

Cost and Machinery

High-tech and Expensive Requirement for Freeze Dryer -Picture Courtesy: Industrial-Integration

Vacuum Dryer	Freeze Dryer
The process uses less and inexpensive equipment, making vacuum drying inexpensive.	Freeze drying requires sophisticated, high-cost equipment due to refrigeration systems, vacuum pumps, and special chambers.

9.Does the Vacuum Dryer Follow a Batch or Continuous Process?

Today, vacuum dryer are available in a broad category that follows both processes such as batch and continuous process.

Vacuum dryer- Picture Courtesy: Tefic. biotech

Nevertheless, lab vacuum dryers or many benchtop vacuum dryers are designed in a way that follows a batch process. This means you can load samples for treatment and receive them once cooled and dried. For example, double-cone rotary vacuum dryers, conical, vertical vacuum dryers, etc.

Design flow chat of continuous vacuum dryer- Picture Courtesy: nara.co.japan

However, newly developed innovation ensures a continuous process by supplying and discharging the sample with the help of supply valves making it possible to achieve a constant and continuous vacuum drying process.

10.What are the technical problems associated with vacuum dryer? How to solve them?

Vacuum dryers are extensively employed in numerous industries for effective drying of various materials and products. But have you ever come across some technical issues with their performance? Let’s dive into some common snags associated with vacuums and how you can deal with them.

Having Trouble with Insufficient Drying Efficiency

Vacuum Pump Maintenance

Issue

Troubleshooting

If there isn’t enough vacuum or less efficient heat transfer, have you observed the drying process dragging on? These two considerations can slow down the performance and the productive moisture removal.

To keep things running smoothly, make sure that:

The heating components are in working order.

The vacuum pump has to be sized appropriately and serviced frequently.

Periodic calibration of the system for both temperature and pressure.

Coping with Equipment Contamination

Contamination Control- Picture Courtesy: Griffin Machinery

Issue

Troubleshooting

Lubricants, residues, or even dust from the vacuum chamber can sneak in and deteriorate the quality standard of your product.

To keep your vacuum dryer in excellent order, keep these points in consideration:

The materials used are repellent to contamination.

Keep an eye on vacuum chamber leakage.

Look over for residue and contamination regularly.

Let’s have a satisfactory cleaning maintenance routine in place.

Lack of Exhaust Control

Valve for Exhaust Control- Picture Courtesy: Amixon GmbH

Issue	Troubleshooting
Have you ever noticed that introducing dry air or nitrogen during the drying process might impact fine powder? If the exhaust flow is inadequate, it can lead to powder washing away and particle loss.	Using a regulator or valve to accurately control the exhaust stream can really help manage problems that arise with the introduction of nitrogen or dry air. It’s crucial to pay attention to balancing water vapor elimination without losing powder.

Noticed Vacuum Level Fluctuations

Vacuum Stability- Picture Courtesy: MJ Dryer

Issue	Troubleshooting
Have you ever encountered rapid variations in a vacuum? It may lead to the powder material escaping into the atmosphere.	Keep in mind that the vacuum level needs to be adjusted gradually. Rapid changes can affect the stability of particles and create dust.

Facing Temperature Control Issues

Temperature control system inspection- Picture Courtesy: BINDER GmbH

Issue

Troubleshooting

This is pretty common that utmost alterations in drying temperature generate excessive heating, In fact, affects the quality of the product.

Ensure these key aspects:

Frequent calibration of sensors.

Uniform heat distribution—temperature profiling.

Spotting Vacuum Leakages

Leak Proof Vacuum System- Picture Courtesy: Lodha Pharma

Issue

Troubleshooting

If you’re experiencing low-pressure conditions owing to a leak in your vacuum system? Let’s find some quick solution.

Pay attention to:

Manage systematic inspection of seals, gaskets, and connections for any wear and damage.

A vacuum leak detector helps you to detect repair leaks on time.

Struggling with High Energy Consumption

Energy-Efficient Vacuum System- Picture Courtesy: DCM Delta

Issue

Troubleshooting

If you are experiencing incompetent operation and unsatisfactory insulation, this can contribute to enormous energy usage and operational costs.

The possible strategies include:

Optimize the parameters of the drying process for heat loss reduction and to improve insulation.

Moreover, utilize energy-saving components.

Mechanical Failures

Schedule maintenance- Picture Courtesy: MJ Dyers

Issue

Troubleshooting

You may experience a mechanical breakdown decline in efficiency attributed to wear and tear in moving parts of vacuum pumps and dryers. This is particularly concerning for essential components such as seals.

You must consider regular maintenance to identify early wear in parts. This proactive approach helps in sudden mechanical failure and smooth operation. For example:

Incorporate lubrication.

Part replacement.

Regular inspection.

Conclusion

A vacuum dryer is a one-stop solution for drying thermolabile and hygroscopic content in the safest manner. That’s the reason it is used for not only medicinal purposes but also in various fields of manufacturing sectors discussed above. This is a profitable unit in a various way such as energy conservation, saving your time, saving product loss, and much more. Willing to purchase a vacuum dryer? Why not contact our team? Why us? We are the experts in offering a series of reliable and economical machines that firmly adhere to FDA regulations. Send a Quote to begin the journey of success with us.

Don't forget to share this post!

CONTACT US

Tell us your raw material and project budget to get quotations within 24 hours.

WhatsApp Us: +86 181 7101 8586

The Buyer's Guide

Want to get Best Price Vacuum Dryer from China?

Tell us your material or budget, we'll reply you ASAP within 24 hours

Vacuum Dryer: The Complete Buying Guide In 2025 Read More »

Performance Qualification VS Operational Qualification

Pharmaceutical Standard

Performance Qualification VS Operational Qualification

In the pharmaceutical and clinical industries, even a slight mistake can lead to serious problems. Therefore, in the pharmaceutical, medical device and clinical industries, they should be strictly regulated. In order to ensure the safety and quality of equipment in production and operation, operational qualification and performance qualification are proposed and strictly stipulated.

Performance Qualification VS Operational Qualification-sourced: csolsinc

What is operational qualification and performance qualification? Why they are important? How to perform and what you need to pat attention? Following this performance qualification vs operational qualification post, you may grab the free guide. Let's go!

Add a header to begin generating the table of contents

1.What Is Operational Qualification?

What Is Operational Qualification-sourced: tgm

Operational qualification refers to a series of tests on equipment. Its purpose is to determine whether the equipment performance meets the user's requirements and specifications within the operating range specified by the manufacturer. This type of testing has specific requirements and specifications.

After testing, the performance of the equipment will be recorded. It includes a detailed review of the equipment startup, operation, maintenance, cleaning and safety procedures of the equipment hardware and software.

2.What Is Performance Qualification?

What Is Performance Qualification-sourced: Pharmaguideline

Performance qualification is the next step after operational qualification. It is the final stage of equipment certification. Performance qualification does not test the components and instruments of the equipment separately.

It generally introduces a third-party expert to ensure the thoroughness and accuracy of the equipment. The purpose of this process is to ensure that the product quality of the equipment is continuously guaranteed during its operating time.

3.Performance Qualification VS Operational Qualification: How To Perform?

Unlike operational qualification, performance qualification does not test individual parts of the equipment.

How To Perform Operational Qualification-sourced: Pharmaceutical Specifications

	Operational Qualification: How To Perform
Perform functional tests	l Perform tests to verify that the equipment's operating functions are within the specified range.
Safety measures check	l Test all safety functions of the equipment, including alarms and fault protection, to ensure that the equipment is in normal working condition.
Validation plan development	l Record the complete equipment test performance and data, and analyze the deviation from the expected parameters.
Report generation	l Compile all data reports into a comprehensive operational qualification report in accordance with specifications and requirements for subsequent retrieval and review.

How To Perform Performance Qualification-sourced: gmpinsiders

	Performance Qualification: How To Perform
Unify performance standards	l Clear and unify the performance standards of the equipment under operating conditions.
Long-term equipment testing	l Run the equipment for a long time to record and evaluate its long-term performance.
Environmental condition testing	l Run the equipment in different environments and conditions to record and evaluate its performance.
Data analysis	l Verify, correct and re-test the different differences shown by the equipment under different environments and conditions.
Report generation	l Compile all data into a detailed performance qualification report for subsequent retrieval and review.

4.Performance Qualification VS Operational Qualification: What Makes Them Successful?

After the operational qualification and performance qualification are performed, you may know whether they are successful through the following standards and indicators. They are:

OQ-sourced: nodeviation

The equipment can operate normally within the operational range;

All operational tests meet the acceptance criteria of the operational qualification protocol;
During the test, the equipment operation has no deviations or unqualified conditions;
During the test, the deviation of the equipment operation will not affect the overall capability or other performance of the equipment;
The equipment can correctly identify and handle faults and errors;
It can connect other integrated equipment without any compatibility issues or interruptions;
Positive operator and user feedback;
The operational qualification test is successfully completed and all standards are met.

PQ-sourced: media

The equipment's products and product processes meet the standards;
The equipment's process capabilities are stable and meet the standards for a long time;
The equipment's system can handle multiple products without lag problems;
The work processes will not affect each other;
The equipment can correctly identify and handle different known materials;
The equipment can operate normally and meet the relevant standards in actual work;
The equipment can automatically identify some potential unqualified conditions during operation, including: overheating, excessive vibration, noise, pressure difference, process medium back-flow, etc.

5.Performance Qualification VS Operational Qualification: Why You Should Perform PQ And OQ?

Why should you obey and perform the operational qualification and performance qualification? In short, this is the FDA's requirement. To expand, its benefits are:

Reasons to Perform Operational Qualification-sourced: polarseal

Reduce risks

Obtaining operational qualification in advance can reduce the risk that the equipment cannot operate normally or as expected, thereby it can reduce the loss of users.

Protect equipment parts

If the equipment does not pass operational qualification, it may face risks such as component damage, software problems, and workflow problems. After operational qualification, these problems can be well eliminated and parts can be protected from damage.

Help manufacturers improve

Only through a series of tests in operational qualification can equipment manufacturers find problems and make corresponding improvements. Therefore, the upper and lower limits of the equipment can be determined and the corresponding operating standards can be made.

Reasons to Perform Performance Qualification-sourced: polarseal

Eliminate potential equipment problems

The hardware and software problems of the equipment may meet the standards, but it is difficult to find other potential problems without operating tests. For example, overheating, excessive vibration, noise, pressure difference, etc.

Ensure equipment performance

Through performance qualification testing, the normal and stable operation of the equipment can be guaranteed, thereby ensuring the performance of the equipment for a long time.

Forming validation documents

If any problems occur during the use of the equipment, the verification documents of performance qualification can be used to eliminate the problems in the operation of the equipment and help users, manufacturers or regulatory agencies to find the cause.

6.Performance Qualification VS Operational Qualification: What Are Their Essential Documentation?

When the equipment has passed the operational qualification and performance qualification, a comprehensive document will be formed. It includes:

OQ Documentation

OQ Documentation-sourced: golighthouse

Operational qualification documentation mainly includes the equipment's objectives, scope, methods, acceptance criteria, requirements, and reports.

Objective: clarify the equipment's objectives, specific operating parameters and functions that need to be tested.

Scope: equipment-related components, systems, hardware, software, and operating procedures;

Methods: equipment operating steps and procedures, related conditions and settings, etc.;

Acceptance criteria: what conditions the equipment needs to meet to pass each test;

Requirements: manufacturer and user specifications, supervision of equipment, etc.;

Report: OQ report mainly records the execution and test results of the equipment, including whether it is faulty, whether there is deviation, etc.

SOP: mainly includes equipment operation, maintenance, calibration, processing, recording deviation and other procedures.

PQ Documentation

PQ Documentation-sourced: golighthouse

Performance qualification documentation mainly includes equipment pre-qualification inspection, program testing, data collection, acceptance criteria, deviation management, document formation, document approval and review.

Pre-qualification inspection: ensure that the equipment has been properly installed and calibrated, and properly maintained;

Procedure testing: ensure that the content and process of the equipment's system procedure testing are fully executed;

Data collection: determine the data collection method and ensure that the data collection tools and systems are operating normally;

Acceptance criteria: clarify that the equipment's acceptance criteria meet industry standards and regulatory requirements;

Deviation management: debug, correct, record and retest equipment with data deviations;

Documentation: ensure that all required documents are complete and correct;

Approval and review: requires review and approval by relevant personnel.

7.Performance Qualification VS Operational Qualification: What Are Their Reports?

Compared with operational qualification documentation, its reports are simpler. It is mainly used to verify whether the equipment system, software or hardware operates as expected.

OQ reports

OQ reports-sourced: biotechserv

List of test items for equipment acceptance criteria;
Documentation for executing equipment test runs;
List of information about equipment test items and sequences;
List of designated equipment test tools;
List of equipment acceptance criteria;

Performance qualification reports are the final documents for the entire equipment. It indicates that the equipment has passed the test and meets all standards.

PQ reports

PQ reports-sourced: dicksondata

Test summary: including an introduction and objectives of the equipment test;

Summary of test content: detailed description of the equipment execution process, including test methods, environmental conditions and test results;

Data analysis: the analysis and improvement of data deviations and qualification process;

Test conclusion: summary of test results;

Test recommendations: recommendations for improvement and adjustment of subsequent equipment;

Approval: signature of test and responsible personnel;

8.Performance Qualification VS Operational Qualification: What Are The FDA Requirements?

FDA attaches great importance to the qualification process and it is part of its regulation. The purpose is to allow drugs and medicines to be manufactured under normal and controlled conditions. Their requirements are:

Comply with good manufacturing practices

Comply with good manufacturing practices-sourced: eriks

FDA requires that devices should follow good manufacturing practices. This includes accurate documentation, precise data collection, and performance testing that meets standards.

Data integrity

Data integrity-sourced: fivevalidation

Whether you perform operational qualification or performance qualification, you need to ensure the accuracy, consistency, authenticity, and reliability of the test data during the test process. If there are any deviations, they need to be marked and explained.

Document compliance

Document compliance-sourced: docsvault

You need to archive the qualification process and related documents to facilitate audits and supervision by subsequent staff.

9.Why Is Performance Qualification And Operational Qualification Critical In The Pharmaceutical Industry?

The operational qualification and performance qualification are critical in the pharmaceutical industry rather than other industries. Reasons are:

Regulations of the U.S. Food and Drug Administration (FDA)

Regulations of the U.S. Food and Drug Administration (FDA)-sourced: thefdagroup

This is a hard requirement of the FDA. The FDA believes that equipment certification is essential for the production and production of drugs. Any manufacturer needs to ensure that their equipment is well designed, easy to clean and maintain, and has the prescribed effectiveness and suitability.

Product quality assurance

Product quality assurance-sourced: sofeast

Only equipment that has passed operational qualification and performance qualification can its quality be guaranteed. And it can help drugs to be produced safely and accurately.

Patient safety assurance

Patient safety assurance-sourced: encrypted

Even the slightest equipment installation error may cause the produced drugs to have fatal consequences for patients. Only by ensuring the production and operation safety of the equipment can the safety of patients be guaranteed.

Help record and track

Help record and track-sourced: integrity-asia

Even if the equipment has passed operational qualification and performance qualification, there is a chance of problems in the later operation. Therefore, the relevant test records can well help users troubleshoot, record and track.

10.What Types Of Tests Are Conducted During Performance Qualification And Operational Qualification?

There are specific tests need to be conducted during the operational qualification and performance qualification.

The main OQ test types are:

The main OQ tests-sourced: media

Functional test: mainly checks whether the equipment operates as expected;

Stress test: evaluates the operating effect of the equipment under extreme conditions;

Calibration check: ensures the accuracy and stability of the equipment;

Repeatability test: takes the average of multiple running results to evaluate the stability of the equipment.

The main PQ test types are:

The main PQ tests-sourced: susupport

Operating range test: evaluates the upper and lower limits of the equipment;

Calibration and verification check: compares and verifies with known standards to ensure accuracy and consistency;

Sample analysis: tests samples produced during the operation of the equipment to check whether their quality meets the standards;

Integration test: connects with other whole-line equipment to ensure the smoothness and stability of the whole line.

11.What Happens If Performance Qualification And Operational Qualification Test Failed?

Operational Qualification and Performance Qualification Failed-sourced: chapter5academy

If the operational qualification and performance qualification tests fail, the reason may be that the test results did not achieve the expected effect, or the data produced a very large deviation. This equipment may need to be adjusted, repaired or re-qualified. The operational qualification and performance qualification can be re-qualified by re-adjusting the equipment.

12.What Are The Best Practices For Writing Performance Qualification And Operational Qualification Protocols?

After passing the operational qualification and performance qualification, you need to write the corresponding qualification protocols. You can follow the practices below to do this.

Practices For Writing Operational Qualification Protocols

Operational Qualification Protocols-sourced: madgetech

Operational Range

Normal environment testing, upper and lower limit environment testing. For example, you can test the device at the highest speed and the lowest speed range. This ensures that the device maintains stable performance during variable production requirements.

Failure Mode Testing

Test the device's ability to detect and handle fault conditions by simulating fault scenarios. This evaluates the reliability of the device's protection measures and management system.

Interoperability Testing

Connect the device to other devices or other complete lines to test the device's interoperability. To ensure seamless connection and online between systems.

Execution Sequence Testing

Have the device operate the test as required and record the execution sequence. This can reflect the use of the device during the production cycle, ensuring a smooth and efficient production workflow.

Load Testing

Load the device under different conditions, including maximum capacity and variable load. This ensures that the quality and reliability of the device can be maintained under load.

Practices For Writing Performance Qualification Protocols

Performance Qualification Protocols-sourced: madgetech

Real-time Monitoring

Use real-time monitoring tools to analyze and summarize the real-time data provided during the operation of the equipment for subsequent adjustments.

Dynamic Adjustment

Combined with the application of process analysis technology, dynamic adjustment of parameters is performed.

Scalable Protocols

Design scalable protocols. Make sure that the protocols you design are scalable. This will facilitate the subsequent test process to expand the production scale.

13.Performance Qualification VS Operational Qualification: What Is An Equipment Qualification Protocol?

Equipment Qualification Protocol-sourced: egnyte

The equipment qualification protocol is a written plan. It describes the qualification process of the equipment. This protocol mainly includes the component evaluation of the equipment, the steps of OQ and PQ qualification, parameter testing, product testing, and the production process and deviation handling.

Step 1

Write and formulate the protocol. A detailed document is prepared by relevant staff or experts. It mainly includes the scripts, methods and steps you need to test. Standardize acceptable test results. Specify relevant parameters and acceptance criteria.

Step 2

Prepare the pre-checklist. Evaluate the system for equipment inspection and testing to ensure product quality and user safety. Establish and divide the corresponding time and responsibilities.

Step 3

Thoroughly understand and inspect the equipment. Understand the intended use and effect of the equipment and recognize the functions of the equipment.

Step 3

Test the equipment according to the requirements and specifications. And collect the necessary documents and data. Handle it according to the design specifications and standard operating procedures.

Step 4

Understand the documents and processes required for certification OQ and PQ. Understand the overall process flow of the equipment.

Step 5

Review the FAT and SAT records that have been carried out. Conduct evaluation and analysis.

Step 6

Thoroughly review current regulatory guidance and warning letters. Develop clear and concise protocols.

Conclusion:

Operational qualification and performance qualification are key processes in the pharmaceutical industry. In addition to enabling equipment to operate continuously and effectively, they also ensure product compliance, high quality, and safety. Through this complete performance qualification vs operational qualification guide, you can also follow such a guide later. If you have more questions, you are welcome to consult ALLPACK now!

Don't forget to share this post!

CONTACT US

Tell us your raw material and project budget to get quotations within 24 hours.

WhatsApp Us: +86 181 7101 8586

The Buyer's Guide

Want to get Best Price Viscosity Tester from China?

Tell us your material or budget, we'll reply you ASAP within 24 hours

Performance Qualification VS Operational Qualification Read More »

Performance QualificationThe Complete FAQ Guide In 2025

Pharmaceutical Standard

Performance QualificationThe Complete FAQ Guide In 2025

If you are in the process of getting GMP standard, you may know the performance qualification which also called as PQ in many place. It is the qualification which test the processing performance of your industry. You cannot ignore it if you want to make your manufacturing process reliable and efficient.

How much you know about it? Why you need performance qualification? What industry can performance qualification be applied? What is performance qualification testing? Performance qualification isn’t a complex qualification. After the reading of this post, you may become the expert in performance qualification!

Add a header to begin generating the table of contents

1.What Is Performance Qualification And What Its Aim?

Performance Qualification- Sourced: ciqa

Performance qualification is the kind of qualifying test which tests your equipment to find its process and working problem in expected or actual condition. It can help you find the potential problem in your processing and can prove the right processing result and safe and consistent manufacturing process.

To get your GMP standard, you may give the performance qualification process which shows the standard and qualified equipment working process. It aims to promote the smooth and consistent equipment performance and gets the right results. This qualification can be applied in manufacturing of medical products , instruments and utilities.

2.Why YouNeed Performance Qualification?

Why you need performance qualification? Is it essential for your manufacturing. In a word, one cannot get your GMP standard without your performance qualification. And besides, it also has other benefits which will promote your manufacturing business.

Make standard processing

Make Standard Processing-Sourced:geeklymedia

Performance qualification can prove your manufacturing equipment and process in standard. The standard processing may prove the smooth and efficient manufacturing. You may thus get the high efficient work and have your profits improved.

Prove product quality

Prove product quality-Sourced :corporatevision-news

Performance qualification investigates the manufacturing process. For the unqualified or unreliable tactic, the timely optimizing can avoid the making of the unqualified results. It in some way prove your results’ quality and can force the production line to make products with high quality.

Reduce your business risk

Reduce Your Business Risk-Sourced:integrify

Performance qualification can reduce your business risk as it identifies and corrects problems. The minimizing of problems and deviation reduce your business risk. And the standard performance which align with law, business requirements and user requirements can also help reduce your business disputes.

Better regulation

Better Regulation-Sourced:sloanreview

For any problem in manufacturing or using process, the well recorded performance qualification may give the relative documents as evidence. This helps the efficiency of problem solving as it improves the speed of regulatory authorities and manufacturer to retrace and solve problems.

3.What Industry CanPerformance Qualification Be Applied?

Performance qualification can be applied in many places as it is an essential part of GMP standard. Here are the representative industries which required the performance qualification.

Medical device industry

Medical Device Industry-Sourced:brighton-science

There is a legal requirement of FDA about medical device. There are also clear requirement on machine designing, locating, performing, maintaining and so on. For the medical device industry which updates with high speed, performance qualification is essential as it proves the great performance of machine and takes the reliable and safe processing.

Pharmaceutical industry

Pharmaceutical Industry-Sourced:viracresearch

Performance qualification is very important in pharmaceutical industry. It improves the manufacturing process and tests the feasibility of manufacturing. Performance qualification helps make the welcomed and reasonable medical products.

Food industry

Food Industry-Sourced:amtrustfinancial

In food industry, performance qualification is also inescapable. It proves the actual smooth, safe and efficient manufacturing by testing the food making process. And it also can avoid risk by careful testing of performance. In a word, it assures the food quality and your business profits.

4.Why Performance Qualification Is So Important In Pharmaceutical Industry?

In pharmaceutical industry, performance qualification takes an important position and makes a lot for great pharmaceutical products manufacturing.

Test feasibility

Test Feasibility-Sourced:rmsresults

Performance qualification is an important part to test feasibility. There are various medical dosage and also various medical device type. To get the real suitable one, you should make the strict performance qualification to test the feasibility of your pharmaceutical production line.

Make qualified products

Make Qualified Products-Sourced:oktopost

To make the qualified medical products, you should first of all make sure the pass of performance qualification. The performance qualification acceptance criteria can prove the qualified manufacturing and products making. Besides, the small damage of instruments can also be found and solved for the nice and qualified products making.

Prove the processing efficiency

Prove The Processing Efficiency-Sourced:businessmapping

Performance qualification tests the capability for the consistent operating. It also tests the efficiency of other tactic and operation. In performance qualification, you can find the flaws in processing and improve your efficiency by improving or ameliorating the missing part. The medicine processing efficiency can improved in this way.

5.What IsPerformance Qualification Testing?

To pass the performance qualification, you may first get the performance qualification testing. Here are some of the detailed testing contents.

Operator training

Operator Training-Sourced:nhancetech

There are standard in operating parameter and limits in performance qualification. Thus, you should make the special operator training to standardize operating. You should make clear the operator parameter and limits of your field and then trained your workers to make the reliable operation.

SOP

SOP

SOP-Sourced:ceomastery

SOP is the abbreviation of standard operating procedure. It includes the cleaning, maintaining, operating and other procedure for equipment or processing system. In performance qualification testing, SOP is also an essential part which shows the regulation and standard of equipment processing.

Production material

Production Material-Sourced:happho

Performance qualification testing uses production material, qualified substitute material or simulated products to get reliable results of different operating conditions. It can thus get the appropriate production material and get the results of different operating parameters under different material.

Processing parameter

Processing Parameter-Sourced:corporatefinanceinstitute

Processing parameter is one deciding factor which affects the manufacturing efficiency and products feature. In performance qualification testing, there is also part for the processing parameter investigation and study.

6.What Are The Requirements For Performance Qualification?

It is suggested that performance qualification should be written well with great care and concerns. And here are the requirements for your performance qualification.

Requirements on operation

Requirements On Operation-Sourced:zenbusiness

The requirements on operations make the regulation on manufacturing condition and operating manner. You should make clear testing operation like standard operation parameter, instruments limits and inputting number. You should also make clear the material applied in performance qualification testing.

Requirements on time

Requirements On Time-Sourced:laurabrandenburg

Time is the important parameter for performance qualification. There are requirements on time frame in repeatability, time limits and so on. There should be requirements on time as it in some way affect the operational parameter.

Requirements on test plan

Requirements On Test Plan-Sourced:qaworld

The test plan should make the clear requirement on material, testing machine, calibration manner, validation manner, assessing manner, sampling plan and so on. Besides, you should also make clear the way to deal with unqualified situation and remediation manner for the emergency condition in performance qualification testing.

Requirements on operator

Requirements On Operator-Sourced:flaticon

The operators for performance qualification are varied. You should make clear their qualification and training plan. There are also other relative personnel for different department for you consider for smooth and reliable performance qualification.

7.What Is Performance Qualification Acceptance Criteria?

The qualification acceptance criteria isn’t that difficult or complex. Here is the essential qualification acceptance criteria which may guide your behavior in performance qualification.

Temperature monitoring

Temperature Monitoring-Sourced:zenatix

Temperature monitoring provides the essential evidence about temperature products maintained in processing or transporting. The temperature should be set according to the operation norm in SOP. Temperature should not be neglected as it in some way affects manufacture processing and also the products feature.

Packaging integrity testing

Packaging Integrity Testing-Sourced:purple-diamond

Performance qualification has the visual inspection for packaging. The primary, secondary, tertiary packaging and ancillary components should be inspected with great care. In this part, you should emphasize the integrity of packaging and products. The integrity can be assessed by limiting quality, inspection, sample plan and so on.

Transporting process confirming

Transporting process confirming-Sourced:mykn.kuehne-nagel

Your well made products may get damage in transporting. There are minor, major and critical damage for a product. And the smallest damage may lead the interest damage as it reduce the products integrity. There are functionality testing, product quality attribute testing and container closure integrity testing in performance qualification as testing manner.

8.What Element Should Be Considered In Performance Qualification?

There are several essential elements which you should considered seriously in performance qualification. The violating of these elements may lead the mistakes in performance qualification

Accuracy

Accuracy-Sourced:documentmedia

The results of performance qualification should be precise or the wrong results may affect your later processing. Accuracy is one of the most important element of performance qualification. The precise results is the base for qualified products making and reliable analytical data.

Stability

Stability-Sourced:thebluediamondgallery

You may assure the stability of your performance qualification result. You may also prove the stability of results by investigating instruments or equipment seriously. The assurance of stability in performance qualification makes sure the little deviation or fault in operating.

Repeatability

Repeatability-Sourced:aivaraszvinklysofficial

There are so many factors which may affect your performance results. To get the reliable products results, you should make the repeated testing. The repeated testing can reduce the affect of changing factors happened in regular operating. The repeatability can thus makes the more dependable results.

Regulatory Compliance

Regulatory Compliance-Sourced:essentialdata

Performance qualification makes the strict investigation about the relative law or standard the industry applied. To pass the performance qualification, the equipment and instrument must adhere to the relative GMP, cGMP, SOP and other relative laws or regulations. The violating of regulation may lead fail in performance qualification and damage to your business.

Document compliance

Document Compliance-Sourced:cio

The strict and precise data is one powerful evidence for performance qualification investigation. The careful recording of various data in manufacturing process is thus irreplaceable in performance qualification. You should record as detailed as possible. Besides plan and results, the deviation is also helpful in trace.

9.What Are The Key FeaturesOne Should Consider In Performance Qualification Phrase?

In performance qualification phrase, one should take much emphasis on the key features which affect your qualifying phase when making the performance qualification testing.

Controllable environment

Controllable Environment-Sourced:starrco

For performance qualification, you should make the controllable environment. You may then test the typical operating environment and the worst one. The controllable environment can thus assure accuracy in consistent and repeated testing. Environment can make much influence on performance qualification testing.

Comprehensive document

Comprehensive Document-Sourced:myinnovative

The documents for performance qualification should be comprehensive and thorough. Besides standard operating procedure, your documents should also include training part, maintaining part and so on. You should thus make the comprehensive documents which offered to all equipment user for standard performance.

Tractable data

Tractable Data-Sourced:reltio

The data of performance qualification must be tractable. You would better save data backup, archiving or make other plan for your data. The tractable data is the prove for integral and comprehensive performance qualification.

10.What Common ProblemsCan Performance Qualification Identify?

In your performance qualification phrase, there may be some problems. Here are some common problems which may be found from performance qualification and you may just relaxed when come cross with it.

Excessive heat

Excessive Heat-Sourced:slatesafety

The consistent testing of performance qualification may lead the excessive heating of equipment or instruments. For the excessive heat, you may just pause the operating and wait second for later operating. The insisting on operating while ignoring heating may lead problem on equipment or instrument.

Excessive vibration

Excessive Vibration-Sourced:memtechacoustical

Excessive vibration is also the common problems in testing for performance qualification. It may caused by various reasons and you may stop machines and solve the relative problems. Vibration may began in many occasion, just relaxed if it happened in your performance qualification.

Excessive noise

Excessive Noise-Sourced:magicvalleypublishing

The excessive noise just like excessive vibration or heat comes for various reason. You may just stop and repair it if it comes for the excessive operating. And you may also guarantee your performance qualification accuracy by making other test under the same circumstance to see its noise condition.

Process media back flow

Process Media Back Flow-Sourced:tvwd

Process media back flow when solution comes form one drainage pipe and went to another one. This may induce the bursting and product damaging. It comes from various reason from broke pump, plumping overhauling and so on. You should find the problem and make the timely repairing. For stricter results, you’d better test several more times on this part.

Pressure difference

Pressure Difference-Sourced:elgi

Pressure difference is also a common problem in performance qualification. The pressure difference may caused by liquid difference or environment. For this problem, you should find the cause and solved it. And then the more testing on this part may make more just results.

11.Are ThereOther Qualification For Equipment Qualification?

Have you ever wondered the existence of other qualification besides equipment qualification. There of course are other qualifications. Here are the other three representative qualifications for manufacturing besides performance qualification.

Design qualification

Design Qualification-Sourced:dr-sharayu-sawant

For many manufacturer, product designing is a deciding part. It decides the capability, manufacturer warranty, powder needs and so on especially for medical device. The safety and efficiency of device or equipment are also tested in this part. From design qualification, the performance and use of device are considered thoroughly.

Installation qualification

Installation Qualification-Sourced:sifo-medical

Installation qualification may find if your parts or components installed well according to manufacturer’s requirements. The successful installation qualification should follow the manufacturer’s guideline and requirements strictly. Installation qualification covers a wide range of process including inspection, documenting and so on.

Operational qualification

Operational Qualification-Sourced:angstromtechnology

After the meeting of installation qualification, operational qualification comes to make sure the equipment performance adhere to regulation. In operational qualification, the quality of instruments are inspected with great detail to ensure the great performance and productivity of relative equipment or device.

Conclusion

The complete FAQ guide in 2024 for performance qualification shows you the detailed information about this protocol. The deeper understanding of performance qualification may help you control your manufacturing process better. If you have any problem on performance qualification, you may just contact ALLPAK.

Don't forget to share this post!

CONTACT US

Tell us your raw material and project budget to get quotations within 24 hours.

WhatsApp Us: +86 181 7101 8586

The Buyer's Guide

Want to get Best Price Viscosity Tester from China?

Tell us your material or budget, we'll reply you ASAP within 24 hours

Performance QualificationThe Complete FAQ Guide In 2025 Read More »

FAT And SAT:The Complete FAQ Guide In 2025

Pharmaceutical Standard

FAT And SAT:The Complete FAQ Guide In 2025

There are many processes involved in the production and commissioning of equipment. Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) serve as two vital stages. The completion of acceptance at these two stage represents that the machine is qualified.

How much do you know about these two types of acceptance testings? Why are these two acceptance testing means so important? Are you curious about the similarities and differences between them? Do you know their procedures?

Well, today, let’s explore the complete FAQ guide of FAT and SAT.

Add a header to begin generating the table of contents

1.What is FAT?

Factory Acceptance Testing - Sourced: NSFLOW

The full name of FAT is Factory Acceptance Testing. As the name shows, FAT refers to the inspection of equipment at factory, that is, before it is delivered to customers.

During the factory acceptance testing stage, both the customer and manufacturer will take part in the acceptance at the manufacturer’s factory. The goal of this testing is to confirm whether the equipment meets the specifications as expected.

2.What is SAT?

Site Acceptance Testing - Sourced: Issuu

SAT, officially known as Site Acceptance Testing, is conducted after implementing FAT. This testing means refers to checking whether the equipment is functioning properly at the customer’s site.

There are several content involved in SAT. Generally, SAT includes inspections of the mechanical appearance, electrical wiring, and other aspects of the equipment.

3.Why is FAT and SAT so Important?

As two vital stages in the acceptance testing of equipment, do you know why FAT and SAT are important processes? If you are curious about it, let’s move on the importance of FAT and SAT.

Importance of FAT and SAT - Sourced: BF Group

According to the above figure, FAT and SAT are two important acceptance stages in the equipment production to delivery process. Strict acceptance criteria and detailed testing data are key to the successful execution of FAT and SAT.

For factories, FAT is important means to ensure product quality and production safety. Through professional testing, factories can discover problems and hidden dangers in the machine’s production process, and take timely measures to improve production efficiency and machine’s quality. In addition, FAT can also help factories comply with legal and regulatory requirements, avoiding fines and legal liabilities caused by illegal operations.

For customers, SAT is also an important way of ensuring product quality. User conduct site acceptance testing of the equipment to ensure that its performance and functionality meet expectations in actual usage environments. This step ensures that the system can work stably and reliably under actual operating conditions, and meet the needs of users.

4.What are the Benefits of FAT and SAT?

Why we need conduct FAT and SAT? These two stages play a crucial role in the delivery, installation, and commissioning of equipment. Through these two stages of acceptance procedures, it can be ensured that the equipment can operate smoothly and meet the needs of users. Are you curious about their detailed benefits?

(1)Meeting customers’ requirement

Meeting Customers’ Requirement - Sourced: protoplastics.com

Satisfying the customer’s need is the ultimate objective of product. FAT and SAT can check that the machine whether meet the customer’s requirements. Once the equipment passes the inspection, it can proceed to the next step.

(2)Safeguarding the quality of the equipment

Through professional testing of FAT and SAT, problems with the equipment can be identified and timely adjustments and repairs can be made to ensure the quality of the final product, and ensure that system components and overall performance meet industry standards..

(3)Saving time and cost

Saving Time and Cost - Sourced: Applied Performance

By conducting FAT and SAT, machine problems can be detected and reported to relevant departments for timely repair, thereby avoiding rework and maintenance costs caused by final product quality issues.

(4)Reducing risk

Reducing Risk - Sourced: 54 Collective

These two testing methods can avoid certain risks. By testing the system in a controlled environment, potential issues can be identified and fixed, reducing the risk of failure after on-site installation.

5.What are the Similarities between FAT and SAT?

We have learned that FAT is conducted at the manufacturing plant before shipment, and SAT is the on-site testing of installation after shipment to the user. As two acceptance testing, FAT and SAT testing methods have some similarities, mainly including:

(1)Quality and safety assurance

Quality Assurance - Sourced: Wise IT

The main purpose of FAT and SAT is to test the quality and safety of products and meet customers’ need before they are put into use.

(2)Requiring documentation

During the process of FAT and SAT, the test date and corrective behaviors need to be documented and a final FAT/SAT report need to be written.

(3)Comply with regulatory standards

Regulatory Standards - Sourced: The FAIR Institute

Both FAT and SAT need to be tested according to industry regulations and standards, which are set by agencies such as FDA and EMA.

6.What are the Differences between FAT and SAT?

Although FAT and SAT both belong to acceptance testing and have some similarities, there are also some differences between these two acceptance methods, mainly reflected in the testing site, environmental conditions, and other aspects.

(1)Testing site

Testing Site - Sourced: AIST Global

The biggest difference between FAT and SAT lies in the detection site. FAT is tested at the manufacturer’s location. SAT conducts testing at the customer’s location. After the equipment is successfully delivered to the user’s site, the user representative will conduct SAT to ensure that the performance and functionality of the equipment meet expectations in the actual usage environment.

(2)Environmental conditions

Because they conduct in different sites, the environmental conditions of the testing sites where FAT and SAT conduct are diversified, mainly displaying in compressed air or steam, temperature and humidity.

(3)Documentation

Documentation - Sourced: Zamann Pharma Support

FAT and SAT need documentation, and they are differed in the level of detail of the content. The information in the FAT documentation is more abundant than SAT documentation. FAT needs to undergo more functional and safety testing, with more specific and diverse testing content, in order to guarantee the quality of the product when it leaves the factory.

(4)Time

FAT and SAT are at different time stages in the completion of equipment. FAT conducts before delivering the machine to the customer, and SAT conducts after the installation of the machine.

7.What are the Procedures of FAT and SAT?

Due to the similarities and differences between FAT and SAT, their procedures also have similarities and differences. Well, let’s learn about their detailed process together.

(1)FAT procedure

The common FAT procedure goes through 6 stages, as follows:

Procedures	Description
1.Planning and preparation	Before acceptance, the staff need to develop a detailed acceptance plan, including the equipment to be accepted, the acceptance personnel, the acceptance time, and standards.
2.Visual testing	Checking the appearance of the equipment, mainly including components, labels, joint and painting. It is also necessary to check whether the instruments and accessories are consistent with the contract. In addition, it is necessary to check the wiring of the power supply unit, the input voltage of the power supply, and whether the nameplate is correct.
3.Functional testing	Conducting functional testing on the equipment, including charging and discharging cycles, adjusting parameters, etc.
4.Stability test	When conducting stability tests on the machine, continuous operation for 72 hours is required. Mechanical, electrical, or software adjustments cannot be made without the buyer’s permission.
5.Safety testing	Testing the safety of the equipment, including alarm function, to ensure compliance with safety standards and enable safety protection measures under fault conditions.
6.Documentation	Recording the results of the test and any issues that arise.

(2)SAT procedure

The common SAT procedure goes through 5 stages, as follows:

Procedures	Description
1.Preparation and installation	Before conducting SAT acceptance, it is necessary to make sufficient preparations for the equipment, including installation, debugging, calibration, etc. Preparing for equipment installation and debugging, and reading the FAT documentation. Installing the equipment by technical personnel from the manufacturer at the customer’s location.
2.Visual testing	Check for any damage or issues with the equipment during transportation.
3.Functional testing	Connecting the equipment to other devices and conducting functional testing on the equipment. For control systems, loop verification is a necessary step.
4.Inspection of User Requirement Specifications	Check the user requirements specifications to ensure that the design and functionality of the equipment meet the user’s needs.
5.Documentation	Record the results of the test and any issues that arise.

Overall, the processes of FAT and SAT can be repetitive, both the customer and manufacturer need to send engineers to participate in FAT and SAT, but SAT can detect issues that FAT cannot detect in actual environments.

8.What Items are Included on the FAT and SAT Checklists?

The Factory Acceptance Testing and Site Acceptance Testing Checklist is a comprehensive document that lists the standards, procedures, and requirements for evaluating and verifying the quality and functionality of machine and systems. All FAT and SAT checklists are not exactly the same, but they basically include the following points.

FAT and SAT Checklists - Sourced: Psychology Today

List of testing machines: This mainly records the names and models of the machines that need to be tested.

The reference specification list: It includes a series of related files involved in the FAT and SAT processes, such as dimensions, materials, and performance parameters.

Equipment calibration certificates: A calibration certificate for testing equipment is a document that proves that a specific device has been inspected, tested, and adjusted to meet specific accuracy and precision requirements.

Test data: After conducting functional, performance, and security tests, the operators record test results, including any issues identified during testing.

9.Why Is SAT Conducted After FAT?

One major difference between FAT and SAT is that they are in different time periods, and SAT needs to be conducted after FAT. Do you know the reason behind it?

Generic Project Life Cycle - Sourced: Secura

The picture above shows the generic project life cycle. When the equipment completes FAT, it can ensure the quality of the equipment before leaving the factory. During the transportation of equipment to customers, damage may occur. SAT can further detect quality issues and, when operated in actual environments, can detect problems that were not detected in the factory.

FAT mainly focuses on the manufacturing quality and performance of equipment, while SAT pays more attention to the reliability and stability of equipment in actual use environments. Therefore, site acceptance testing must be conducted after factory acceptance testing.

10.What Should be Considered When Conducting FAT and SAT?

In order to obtain accurate results, we need to consider multiple factors when conducting FAT and SAT.

(1)Using proper materials

Different Materials - Sourced: PixelSquid

Each machine uses different materials, including liquids, solids, and particles. Different materials can affect the testing results, and in severe cases, even the performance of the machine. Therefore, it is necessary to choose suitable materials according to the machine’s user manual.

(2)Training operators and technicians

Training Operators And Technicians - Sourced: Exelliq

It is necessary to enhance employees’ professional knowledge and skills, strengthen their knowledge of equipment testing, verification, and compliance. Technical personnel are required for guidance and installation during FAT and SAT. Operators need to constantly observe the operating status of the machine, identify problems and defects of the machine.

(3)Understanding user requirements specification

User Requirements Specification - Sourced: Post en Dekker blog

During the initiation phase of the project, users provide their expected usage requirements for the production equipment. This instruction needs to be combined with practical factors such as usage purpose, usage environment, and purpose.

Based on sufficient information collected, the equipment requirements should be provided as comprehensively as possible, and these requirements should be verifiable. The descriptions used in the URS should be clear, accurate, and measurable. These requirements include: Product and process requirements, regulatory compliance requirements, operational, maintenance, and technical requirements.

(3)Effective cooperation and communication

Effective Cooperation And Communication - Sourced: GenSight

Effective communication plays an important role in greatly improving work efficiency. Manufacturers and customers need strengthen cooperation and communication. During the FAT and SAT processes, effective communication is necessary to promptly adjust and resolve any issues that arise with the machinery and equipment.

Conclusion

FAT and SAT serve as a significant role in the acceptance progress of machines, which should be taken seriously to ensure the smooth delivery and use of equipment. Have you gained a better understanding of FAT and SAT after reading this article? If you have any further questions about acceptance testing, feel free to contact Allpack at any time.

Don't forget to share this post!

CONTACT US

Tell us your raw material and project budget to get quotations within 24 hours.

WhatsApp Us: +86 181 7101 8586

The Buyer's Guide

Want to get Best Price Viscosity Tester from China?

Tell us your material or budget, we'll reply you ASAP within 24 hours

FAT And SAT:The Complete FAQ Guide In 2025 Read More »

Lab Vacuum Dryer: The Complete Buying Guide In 2025

Laboratory Instruments

Lab Vacuum Dryer: The Complete Buying Guide In 2025

Drying is an integral step in the preparation of different ingredients, especially solid dosage forms. Vacuum drying has significance in drying raw material by lowering the temperature of solvents, leading to energy conservation. Isn’t that sustainable? How vacuum drying is carried out?

The lab vacuum dryer is a dynamic device that quickly and uniformly dries different ingredients- from pharmaceuticals to foodstuff. What are its pros? What are its types? Several questions confuse operators and manufacturers alike. So, we have compiled this guide to improve your understanding of this promising instrument. Let’s enlighten your minds!

Add a header to begin generating the table of contents

1.What is a lab vacuum dryer?

Lab Vacuum Dryer- Picture Courtesy: Labec

A lab vacuum dryer is a specialized category of equipment that effectively vaporizes chemicals, gases, moisture, or watery content from the feed without oxidizing material or causing undesired reactions in it.

It works on the principle of the formation of a vacuum to reduce the vessel pressure below the solvent vapor pressure, resulting in its boiling. The solvent molecules travel to the surface of the feed and vaporize owing to decreased pressure.

It is an integral device utilized in laboratories and manufacturing units for drying, curing, and heat treatment procedures under low-pressure settings. It has higher drying proficiency because of enhanced heat transfer.

2.What are the benefits of a lab vacuum dryer in different manufacturing units?

A lab vacuum dryer is an innovative and cutting-edge machine that has a plethora of features to provide manufacturers and researchers with financial and industrious benefits. A few significant advantages of lab vacuum dryer include:

Improved Product Stability

Improved Product Stability- Picture Courtesy: Homesteading Family

Water content plays a major part in microbial growth. Manufacturers and developers use a lab vacuum dryer to remove moisture content, consequently inhibiting microbial growth. Moreover, by regulating the amount of moisture in the products, this device is essential in preserving product integrity and averting alterations that could affect their functionality and stability.

High Product Quality

High Product Quality- Picture Courtesy: Somafina

Conventional drying techniques tend to damage heat-sensitive materials, resulting in the loss of their structural integrity. The lab vacuum dryer is specially designed to handle heat-sensitive fragile items with its low-temperature drying. Furthermore, there are no issues such as the development of hard and leathery crusts in a lab vacuum dryer, which are quite common with traditional dryers. Therefore, it retains the quality, appearance, and potency of pharmaceutical and food items.

High Product Shelf Life

High Product Shelf Life- Picture Courtesy: 100% Chef

The materials dried with a lab vacuum dryer exhibit longer shelf life because the latter lowers the likelihood of oxidation and hydrolysis. The chemical reactions in the product and their oxidation promote spoilage and degradation chances, leading to a short life shelf.

Rapid Drying Time

Rapid Drying Time- Picture Courtesy: RAYPA

The low pressure due to the vacuum decreases the boiling points of solvents, as a result, the vaporization procedure is accelerated and drying occurs in a short time. Rapid drying times contribute to higher process productivity and throughput in the manufacturing units. This is particularly important in industries- requiring quick movement of products.

Increased Energy Efficiency

Increased Energy Efficiency

Since the lab vacuum dryer minimizes the required drying temperature and time, so this device uses less energy than other standard dryers. Lower energy consumption translates into reduced utility bills, making drying processes in a lab vacuum dryer more eco-friendly and financially viable for manufacturers.

More Product Uniformity

More Product Uniformity- Picture Courtesy: Soln Pharma

Drying in the lab vacuum dryer occurs in controlled settings of temperature and pressure, leading to uniform vaporization across samples. This reduces variances in drying throughput and delivers constant and reproducible outcomes.

Higher Product Yield

Higher Product Yield

The lab vacuum dryer operates at significantly lower temperature situations, so is effective in keeping products safe from overheating in turn preventing their degradation and minimizing wastage. The mild drying conditions decrease product deterioration, contributing to higher proportions of feasible products.

Versatility

Versatility

Lab vacuum dryer is frequently used for drying multitudes of materials- from slurries to solids, powders to liquids- because it can effortlessly process a wide range of materials and is adjusted to accommodate diverse drying needs.

Low Safety Risks

Low Safety Risks- Picture Courtesy: New York Weekly

By using a lab vacuum dryer, productions minimize the safety risks to the operators. There is no formation of vented fumes and particles in the lab vacuum dryer. These undesired drying products are inhaled by operators, making them sick. However, ventilation does not happen in a lab vacuum dryer, so operators managing this device are safer.

3.Where does a lab vacuum dryer find its use?

A lab vacuum dryer has a huge deal of significance in manufacturing fields because of its potential to safely process materials. Let’s discuss various platforms in which lab vacuum dryer is routinely found:

Pharmaceutical Industry

Tablets and Powders- Picture Courtesy: Bluebird Provisions

Lab vacuum dryer has a major role during the drug formulation process, as it delicately removes solvents from active ingredient materials, maintains properties of sensitive material, and does not change the chemical profile of excipients and drug components. So, this instrument is pivotal in increasing productivity for pharmaceuticals, such as orally disintegrating tablets, camphor, and lactose granules.

Chemical Industry

Chemical Resins- Picture Courtesy: Siegwerk Druckfarben

Sometimes, chemicals severely lose their physical attributes and chemical structure on drying with conventional drying approaches. Therefore, a lab vacuum dryer has a key part in the drying of polymers, resins, and fabricated materials because it ascertains product propriety and quality.

Life Sciences Industry

Cell Culture- Picture Courtesy: Pawitra Biotek

Lab vacuum dryer is a part of recurrent biological research protocols to prepare life samples, for example, proteins, enzymes, cell culture, microbes (bacteria), and tissues. It proficiently dries biological materials while upholding their quality and biological activity.

Food and Beverage Industry

Dried Fruits

Lab vacuum dryer dries food products, for instance, fruits, vegetables, spices, herbs, and coffee. It upholds their nutritional quality, color, texture, delicacy, taste, and aroma. This equipment is involved in the dehydration and curing of different types of food products, such as baby powder, milk powder, flavoring, and protein powder.

Cosmetic and Personal Care Industry

Cosmetic and Personal Care Powders

Cosmetic preparations usually deal with botanical and herbal extracts and their potency and integrity are compromised on processing with standard drying methods. Hence, cosmetic preparations like creams, gels, powders, and lotions make use of a lab vacuum dryer, as it gently handles cosmetic products and decreases their likelihood of clumping due to moisture.

Electronic Industry

Semiconductors- Picture Courtesy: Keyence

Oven and hot air drying exert thermal stress on electronic components like semiconductors, circuit boards, and batteries, leading to their cracking and melting. Therefore, manufacturers prefer to use a lab vacuum dryer for the removal of moisture from electrical components, consequently averting the risk of short-circuiting, corrosivity, and other electrical issues.

4.What is the structural design of a lab vacuum dryer?

A lab vacuum dryer consists of several integral components having unique functionalities. Here is a complete list of parts featured in a lab vacuum dryer:

Structural Design of Lab Vacuum Dryer- Picture Courtesy: ResearchGate

Bleed Valve	It is known by terms, such as vent or pressure relief valve. It aids in pressure equalization by reintroducing the gaseous molecule inside the chamber. It gradually restores air concentration, thereby, preventing the immediate air influx, which may degrade the end product.
PID Control	It is a typical type of feedback control mechanism to manage different inputs, such as temperature, pressure, and time. It continuously estimates the difference between the preprogrammed and actual values and controls process parameters, and hence, stabilizes drying conditions.
Vacuum Gauge	The users can easily adjust and control the vacuum level in the lab vacuum dryer by scrutinizing the vacuum level through a vacuum gauge.
Power Button	The basic purpose of the power button is to start and turn off the machine. It powers different electronic parts and safely shuts off heating and vacuum systems.
Double Partition	It is a structural design attribute, consisting of two layers of partition to increase heating efficiency by uniformly dispensing heat across every corner of the chamber. It provides an insulation barrier to decrease heat deficit.
Vacuum Valve	This valve is essential in regulating the air diffusion in and out of the vacuum chamber. It produces a vacuum, maintains it, and releases the said vacuum upon complete drying.
Hinge	It is located at the side of the doors and allows gentle opening and closing of the door. It secures the seal and provides accessibility and safety to operators.
Visible Window	It is a transparent window and is produced from tempered glass. Users can observe the functioning of the device through the visible window without accessing the sealed chamber and disrupting the vacuum environment.
Silicon Seal	This seal is routinely installed in a lab vacuum dryer to ensure the airtightness of the vacuum chamber by averting the leakage of gas in or out of the chamber. There are diverse types of silicon seals, for instance, O-rings, gasket seals, etc.
Material Temperature Sensor	This sensor is pivotal in controlling the temperature of the sample being dried. It offers real-time temperature data and aids in safeguarding thermolabile materials.
Pressure Sensor	It verifies that the desired pressure range is maintained in the chamber. The pressure sensor delivers feedback to the control system and operator by examining pressure changes inside the vacuum vessel.
Condenser	It is usually found in the lab vacuum dryer manufactured for solvent recovery. This device collects and condenses the vaporized solvent chamber with the help of its cooling mechanism (consisting of cold water or refrigerants).
Vacuum Pump	There are several kinds of vacuum pumps in the lab vacuum dryer, for instance, rotary vane or diaphragm pump, which establish a low-pressure environment in the drying chamber by eradicating gaseous components from the chamber. It is located outside the drying vessel and has integrated pipes for maintaining the vacuum inside the chamber.
Air Solenoid Valve	It is an electromagnetic valve that works on signaling by electricity and regulates the flow of incoming and exhaust air. Thus, it keeps the vacuum level in a chamber under the desired threshold.
Infrared Temperature Sensor	It gauges the temperature range of material or component by examining the amount of infrared radiation released from it. This sensor does not come in direct contact with the object but allows the scrutinizing of real-time temperature alterations during the drying process.
Touch Screen	It is an intelligent screen to configure the drying process by programming desired inputs. It is a simple control screen to modify the parameter settings. It stores pre-saved drying recipes to quickly operate the lab vacuum dryer.
Drain Solenoid Valve	It regulates the movement of moisture or vapors to a drainage mechanism. It manages the offloading of condensate materials and other fluids produced while drying and ensures the stability and efficiency of the compartment environment.
Drying Chamber	It is a core component of a lab vacuum dryer in which a vacuum is maintained for drying. It is manufactured from corrosion-tolerant material to resist low-pressure conditions and avert the risk of contamination. It comes with airtight secure safety interlocking doors to uphold vacuum stability. This compartment is typically insulated to prevent temperature fluctuations.

5.What are the working stages of a lab vacuum dryer?

By learning about a lab vacuum dryer, you can gain insight into its working and methodologies, which are fruitful in effective moisture vaporization and high expiry period of products. Therefore, we are discussing the working stages of a lab vacuum dryer for scientists, developers, and engineers, who are inquisitive about details regarding this device:

Loading of Material

Loading of Material” Picture Courtesy: VACUUBRAND

At the start, the samples are gently introduced inside the drying compartment. After loading, the vacuum chamber is completely and securely sealed to establish a closed atmosphere for vacuum drying.

Vacuum Creation and Product Heating

Vacuum Creation and Product Heating: Picture Courtesy: KNF

The vacuum pump is activated which in turn begins decreasing the pressure inside the drying compartment by creating a vacuum. With the pressure drop, the vaporization of the solvent becomes easier. As soon as a vacuum is set up inside the chamber, a controlled heating source is utilized to accelerate moisture evaporation.

Evaporation

Evaporation

The solvents are converted into vapors at lower temperatures and are consistently removed from the drying vessel using a vacuum pump. This prevents vapors from transforming back into moisture. Some lab vacuum dryers are equipped with condensers, where solvents are condensed and recovered.

Cooling and Unloading of Product

Cooling and Unloading of Product

The temperature of materials is decreased inside the drying chamber for their cooling, once the solvent evaporation is completed. The product is kept inside the vacuum for a short interval for stabilization. On successful cooling, the vacuum is slowly discharged to allow re-entry of air in the chamber.

After the restitution of pressure, the door of the lab vacuum dryer is opened and then the dried and moisture-free product is slowly offloaded from the chamber for next-in-line processing.

6.What are the available categories of a lab vacuum dryer?

There exists a diversity in the types of a lab vacuum dryer, including:

Static Lab Vacuum Dryer

Static Lab Vacuum Dryer- Picture Courtesy: News-Medical

It is a kind of lab vacuum dryer in which original products stay immobile on the trays or other holders in the drying chamber. It is easier to maintain and operate because of the lack of moving parts. In the static lab vacuum dryer, the heat is uniformly transferred to every surface of the vacuum chamber, resulting in regulated and even vaporization of moisture.

The rate of drying is slow, especially for thicker products, because of the absence of agitation. Moreover, static lab vacuum dryers have restricted space, consequently limiting the processing volumes of materials.

Its further categorization includes:

Tray Lab Vacuum Dryer

Tray Lab Vacuum Dryer- Picture Courtesy: PharmaChem Cosmetics Industries

It is composed of stationary trays that house products for drying. It has a simple design and is popular for lab, pilot, and small-scale drying due to its precise temperature control. The trays are vertically housed in the rectangular kind of cabinets. It utilizes low-pressure conditions to boost the drying rate.

The minimal volume and ergonomic design increase energy conservation by decreasing the quantity of heating liquid needed.

Lab Vacuum Oven Dryer

Lab Vacuum Oven Dryer- Picture Courtesy: Digivac

It is a type of static lab vacuum dryer and follows the same working principle- dielectric heating principle- as that of a standard oven. However, the lab vacuum oven dryer runs in a vacuum environment to reduce boiling points and boost drying.

The high-frequency electromagnetic radiations interact with molecules of materials, causing them to heat. Lab vacuum oven dryer is different from other static lab vacuum dryers because in the former heat is produced by the transformation of electromagnetic energy into kinetic energy. So, materials are dried from deep within, resulting in quicker drying.

Lab Vacuum Shelf Dryer

Lab Vacuum Shelf Dryer- Picture Courtesy: Labquip

It features a cylindrical or rectangular shape drying vessel in which shelves are stacked over one another. The materials are put on the shelves for drying via conduction. Shelves have their specific heating plates for improved heat transmission and maintenance of accurate temperature across drying planes.

Drying is much more rapid and uniform in the lab vacuum shelf dryer in comparison with the tray lab vacuum dryer.

7.What are the technical problems and troubleshooting relevant to a lab vacuum dryer?

A lab vacuum dryer is state-of-the-art equipment with long lists of handy benefits, however, now and then, it faces some unfortunate issues that potentially halt its operativity, resulting in a loss of profit margins. Nevertheless, there is no need to worry, as these problems are rectified by implementing the following suggestions:

Vacuum Leakage

Vacuum Leakage- Picture Courtesy: Waldner

Sometimes, there is leakage in the air pressure, resulting in a lower drying rate and longer drying cycles. Materials are also subjected to air or moisture, affecting their physical structure and other properties.

Cause

This issue is due to several reasons, for instance, faulty sealing components, broken glass windows, and unsecured connection in the drying chamber or vacuum hoses.

Troubleshooting

To rectify this problem, you should thoroughly check the working condition of O-rings, gaskets, and other seals. Replace damaged seals if required. Inspect the window for cracks and substitute it if broken. Examine connectivity between hoses and tighten all flanges. Pressure drop in the drying vessel can be checked by a vacuum gauge.

Uneven Heating

Uneven Heating- Picture Courtesy: Holland Green Science

It is observed that some product sections remain wet while others are heavily dried and degraded due to uneven heating in a lab vacuum dryer.

Cause

This problem stems from worn-out heating bars, incorrect positioning of trays or products, or inadequate airflow.

Troubleshooting

It is advised to check the functioning of heating bars and substitute malfunctioning ones. Reload the products evenly in the drying chamber without overloading. Reposition incorrectly placed trays and provide adequate air circulation for uniform heat distribution.

Longer Drying Cycle

Longer Drying Cycle- Picture Courtesy: Lab Manager

The problem of longer drying time arises in a lab vacuum dryer, unsettling the smooth workflow of lab operations.

Cause

The issue of longer drying cycles is due to inadequate vacuum settings, low-temperature ranges, and incorrect placement of materials.

Troubleshooting

First, alter the settings of the vacuum pump to attain a low-pressure range, Secondly, optimize the temperature inputs, so that the heating process becomes faster. Reintroduce samples inside the vacuum chamber and ensure the sample load is below the working capacity of a lab vacuum dryer.

Moisture Condensation

Moisture Condensation- Picture Courtesy: Pella Windows

The issue of moisture condensation is encountered occasionally in the device, resulting in vapors on chamber walls liquifying to solvents. This may contribute to the reabsorption of moisture in the dried sample.

Cause

The reasons for this problem are poor heating, inadequate vacuum level, or leftover moisture that has not completely evaporated.

Troubleshooting

It is solved by increasing the temperature in the drying chamber so that it can fully evaporate moisture. Inspect leakage in the vacuum pumps to fix the faults in vacuum levels. Complete moisture evaporation must be observed using suitable temperature and vacuum conditions.

Loss of Product Integrity

Loss of Product Integrity-Picture Courtesy: Freeman Technology

Sometimes, the samples being dried may lose their physical structure, efficacy, or flavor. These materials may be discolored in a lab vacuum dryer.

Cause

The factors that contribute to this predicament are high heat and inadequate vacuum settings that degrade the thermos-sensitive samples.

Troubleshooting

To resolve this predicament, it is important to minimize the temperature to a certain value that is ideal for drying materials. Modify the vacuum level to lower the boiling temperatures of solvents. Heat exposure to samples can be minimized by using a shorter drying cycle in which materials are satisfactorily dried.

Conclusion

In summary, a lab vacuum dryer is an extraordinary machine capable of drying a wide array of samples- ranging from fresh fruits to sensitive drugs. It is a need of today’s green world because it conserves energy. Procuring this instrument is extremely advantageous for labs and small-scale industries, as it opens new arenas of success. For purchase-related queries, you are more than welcome to contact Allpack. We have a wide portfolio of high-quality lab vacuum dryers, customized to fulfill your unique drying requirements.

Don't forget to share this post!

CONTACT US

Tell us your raw material and project budget to get quotations within 24 hours.

WhatsApp Us: +86 181 7101 8586

The Buyer's Guide

Want to get Best Price Lab Vacuum Dryer from China?

Tell us your material or budget, we'll reply you ASAP within 24 hours

Lab Vacuum Dryer: The Complete Buying Guide In 2025 Read More »

Installation Qualification Example: The Complete FAQ Guide In 2025

Pharmaceutical Standard

Installation Qualification Example: The Complete FAQ Guide In 2025

Are you trying to install equipment? Are you trying to minimize hazardous risks during installation? Installation is a must before successfully operating the equipment. Effective installation guarantees the smooth performance of any device. One must follow manufacturer specifications and recommendations to ensure error-free installation. How to verify that the installation conforms with standards?

Installation qualification is an indispensable procedure that ensures the instrument and systems’ safety, quality, functioning, and reliability. It is not only a good practice but also a legal requirement. People are always confused about the definition of installation qualification and what it entails. So, here is a FAQ guide “Installation Qualification Example: The Complete FAQ Guide In 2024” to satisfy ever-curious minds. Let’s look at the list of questions.

Add a header to begin generating the table of contents

1.What is installation qualification?

Installation Qualification- Picture Courtesy: Zamann Pharma

Installation qualification is a module of the process validation protocol that comprises a documented series of steps to assure manufacturers and regulatory bodies of effective delivery, installation, mounting, calibration, and arrangement of devices and systems.

It is the first step in the equipment qualification protocol and records every vital facet of equipment installation and verifies that these installation steps are carried out by following guidelines defined in the design specification, equipment manual, and in-facility user requirements.

Installation qualification provides documented evidence for the correct installation of the instrument and ensures that its installation will not severely impact its functioning. It verifies the installation and configuration of the machine, its components, piping, or service against a manufacturer requirement checklist. This step is performed before operational and performance qualification.

2.What is an installation qualification example?

Installation Qualification Example- Picture Courtesy: GF Machining Solutions

Whether your instrument is physical or digital, once you have configured it, here are some installation qualification examples for you to inspect your installation protocol:

Location Plan	Find a suitable location and ensure its suitability regarding floor space, ventilation, and outlets or drainage system.
Utility Inspection	Verify that various utilities, for example, water, electricity, compressed air, or other facilities are mounted as per design drawings.
Documentation	Collect and review every manual, certification, instruction guide, checklist, and other to verify the validity of every installation step.
Unpacking	Unwrap every piece of instrument and inspect them for wear and tear. Cross-check every step with the manufacturer's guide to ensure you are proceeding in the right way.
Component Verification	Install ancillary parts and other components, for instance, sensors, seals, screws, valves, etc. Ensure that they are fitted and aligned properly.
Recording	Note details like firmware models, serial numbers, and other instrument-related information.
Inspection of Environmental Setting	Examine and ensure that environmental and functioning conditions, for instance, temperature, humidity, and ventilation are according to manufacturer recommendations.
Software Installation	Verify that the updated version of the software is installed in the desired location. Check that the software is set up with correct settings and network accessibility and performs its core functions as anticipated.
Calibration	Carry out every component calibration or adjustment. Record these calibration procedures with their execution dates and tools.
Connectivity Validation	Check every connection and communication is established with secondary or supplementary support components in line with the user guide.

3.How does the installation qualification example serve industries?

Installation qualification example has central importance in ensuring performance and conformity of equipment and systems. It is a critical testing phase that has immense value in verifying the quality and efficiency of procedures in regulated manufacturing units. Let’s detail its important uses:

Compliance with Regulations

Compliance with Regulations

This process is a pivotal requirement for industries overseen by regulatory authorities, such as the FDA, EMA, or, WHO. It confirms that instruments are installed according to configuration parameters set by the manufacturers and governing bodies. Its records are typically inspected during regulatory audits. Therefore, fulfilling the installation qualification example is a failsafe way to meet GMP and ISO quality standards.

Risk Alleviation

Risk Alleviation- Picture Courtesy: PharmOut

This testing validation minimizes risks associated with incorrect installation of the instruments. Improper system installation and configuration could lead to erroneous measurements and faulty treatment procedures. Thus, the installation qualification example mitigates problems related to system malfunctioning, failure, and safety incidents.

Instrument Longevity

Instrument Longevity

The installation qualification example is a reliable approach to monitoring minor errors in the installation process that contribute to problems down the line and affect the working of the system. The rightly configured instrument generally has a lower component breakdown and lasts for many decades.

Records for Auditing

Records for Auditing

The documentation comprising installation qualification examples is a historical record of installation procedures and inspection checklists. It also documents details of operators checking installation parameters and errors that are rectified during the installation step. This report is integral for auditing productions and helps in troubleshooting technical issues that may arise in the future.

Decreasing Downtime

Decreasing Downtime

The installation qualification example serves as a guide for technicians to properly configure the machine first time. So, operational delays and expensive downtime are prevented by following correct installation standards. This also cut down the need for recurrent machine alteration and repairs, saving maintenance costs and operational time.

4.What type of industries need the installation qualification example?

Installation qualification is integral in laying the groundwork for process validation. Since it ensures the stable and effective working of the instruments; therefore, it is needed in various industries, including:

Pharmaceutical Industry

Pharmaceutical Industry- Picture Courtesy: Verywell Health

A wide range of equipment is utilized in the pharmaceutical industry to manufacture top-quality, safe, and potent dosage forms. Pharmaceutical machines, for instance, mixers, blenders, tablet presses, capsule fillers, granulators, etc., must be validated using an installation qualification example checklist to ensure they are fit for working and operate according to expected criteria.

Biotechnology Industry

Biotechnology Industry- Picture Courtesy: BioSpectrum India

Installation qualification example is a proactive step to reduce the adverse risks linked with the installation of biotech equipment, for example, incubators, centrifuges, chromatography devices, spectrometers, and bioreactors. This measure ensures that biotech systems are qualified for their proposed purpose. Therefore, it is indispensable in biotechnology industries for the efficient validation of research protocols and bioengineered products.

Medical Industry

Medical Industry- Picture Courtesy: Asimily

In the medical industry, the installation qualification example serves as an indicator of the safety and quality of medical devices and products. Proper installation of medical instruments- for example, sterilization units, diagnostic tools, surgical devices, etc.- is essential in patients’ treatment and safety. Any discrepancy in the installation of medical devices can jeopardize the life of the patient.

Food and Beverage Industry

Food and Beverage Industry- Picture Courtesy: Kompass Solutions

The installation qualification example is not just a regulatory requirement in the food and beverage industry; it is a significant measure to guarantee consistency in the food and beverage sector. It satisfies the safety and regulatory standards set by HACCP and ISO 22000 for the food industry. By following correct installation qualification examples, brands decrease contamination during manufacturing and build customer trust in the quality of their produced goods.

Chemical Industry

Chemical Industry- Picture Courtesy: Sigma-Aldrich

Different types of instruments- such as chemical reactors, distillation units, pumps, and heat exchange systems- are routinely used in the chemical industries. So, to comply with OSHA, EPA, RCRA, and, NPDES, the chemical manufacturers must perform installation qualification protocol. This validation protocol verifies that chemical equipment is safely installed and does not pose any risk to the operator and environment.

Cosmetics Industry

Cosmetics Industry- Picture Courtesy: More Natural

Compliance with GMP protocols is the first step to successfully marketing and distributing cosmetic products. Deviations in quality assurance steps directly affect the user's health. So, cosmetic brands follow recommended installation qualification examples to verify that their cosmetic products are designed by the highest quality standards.

Electronic Industry

Electronic Industry- Picture Courtesy: Integra Sources

Proper installation of manufacturing units- such as cleanrooms, water assembly systems, and testing tools- is pivotal in electronic and semiconductor fabrication. Thus, an installation qualification example is needed in this industry to verify manufacturing precision and prevent risks like electronic failure and fire incidents.

5.What are fundamental installation qualification example documents?

Installation qualification example is a prerequisite of any validation process and to confirm that it proceeds as required, one must have basic installation qualification example documents, including:

Fundamental Installation Qualification Example Documents

Installation Qualification Protocol

Installation Qualification Protocol

It is a detailed framework that documents the scope, strategy, and, measures to execute the installation qualification example. It further details:

Instrument identification essentials (version, product code, tag, manufacturer, vendor).
Name of devices and systems to be qualified.
Installation needs specified according to the manufacturer's guide.
Environmental conditions for installation.
A worksheet of approval criteria

Installation Qualification Checklist

Installation Qualification Checklist

It is a comprehensive specification list obtained from the installation qualification protocol, encompassing every facet of installation validation. It covers manual component inspection, utility installation, electric connections, calibration, hardware and software installation checkpoints, alignment, screw fastening, installation of axillary parts, and control schematics.

Installation Qualification Report

Installation Qualification Report

In this report, details of steps performed during the execution of the installation qualification protocol are mentioned. It offers a concise summary of detections, observations, and outcomes. Moreover, it explicitly expresses the acceptance or rejection of instrument installation criteria.

6.How do you fulfill the installation qualification example, step by step?

Installation qualification example is a structured procedure, requiring careful planning and a proper mindset. It can be subdivided into five major steps to achieve precise system validation. Let’s discuss step by step completion of installation qualification example:

Steps in Execution of Installation Qualification Protocol

Step 1: Preparation and Planning

Planning of Installation Qualification Protocol- Picture Courtesy: Dickson Data

It is crucial to prepare and plan by reviewing objectives and establishing the scope of installation qualification before starting installation tests. You should define what instruments and parts will be tested and make sure all the applicable facilities are available for installation qualification.

You should also specify how to handle any issue encountered during the qualifying procedure. Similarly, identify and assess perils associated with installation. This is critical to measure the severity and probability of risk and develop suitable risk alleviation approaches.

Step 2: Development of Installation Qualification Protocol

Development of Installation Qualification Protocol

After executing the preparation step, you should develop the installation qualification protocol. This code of conduct should mention the instrument or system, the name of the qualifying test, its methodologies, approval standard, rejection criteria, test outcomes, testing personnel, and date of testing.

It should enlist details of qualification testing to be performed, including assessment. It should specify the jobs, tasks, and responsibilities of personnel who will conduct the qualification process and who will evaluate and accept results. Moreover, references to documents used using qualifying procedures, variances handling, and modification adjustment procedures should be mentioned in the protocol.

Step 3: Implementation of Installation Qualification Protocol

Implementation of Installation Qualification Protocol- Picture Courtesy: Overbook Scientific

The skilled personnel carry out stated tests and examinations during this step to verify that the installation satisfies the preset approval criteria. In the execution phase, the proper installation of the instrument is verified, the calibration of devices is inspected, and the working of control panels is evaluated.

It is pivotal to adhere to the qualification protocol diligently and record the outcomes precisely. Also, any variances and abnormalities during testing should be documented and addressed accordingly. In this way, you can ascertain the reliability and traceability of qualification validation testing.

Step 4: Maintain Records of Installation Qualification Protocol

Maintain Records- Picture Courtesy: Freezerworks

Documentation is a key aspect of the installation qualification example because it offers records of testing tasks and verification of compliance, thus leading to simpler future inspections. It is recommended to document every piece of information like test figures, annotations, conclusion, installation details, qualification methodology, etc. in an explicit and systematized manner during the complete duration of the documentation phase.

This documentation must be detailed, precise, and readily available. This step also includes keeping version changes, utilizing regulated templates, and housing documents in a safe and centralized area in the facility.

Step 5: Review Installation Qualification Protocol

Review Installation Qualification Protocol- Picture Courtesy: Dickson Data

The last step in the installation qualification example is to assess and accept test outcomes and ancillary documentation produced during the qualification procedure.

The authorized personnel should inspect the qualification outcomes thoroughly to attest every prerequisite has been satisfied and if the installation is appropriate for its expected task.

In addition, they should meticulously read the documentation. They should attest that every investigation and examination is performed accurately, that approval criteria were satisfied, and any installation errors are rectified successfully.

7.What are ideal practices for the effective installation qualification example?

The installation qualification example should be executed diligently to avoid any inconsistencies during qualifying tests. So, here are some ideal practices that should be kept in mind to successfully carry out the installation qualification example:

Ideal Practices For The Effective Installation Qualification

Consider Risk Mitigation from the Start

Consider Risk Mitigation from the Start- Picture Courtesy: Soluen Engineering Solutions LTD

It is important to integrate a risk-grounded strategy early on into the installation qualification protocol for recognizing probable risks related to instrument installation and prioritize qualification strategies based on these risks. By this personnel can ensure that serious problems impacting product quality and safety are resolved first.

Go over Past Experiences

Go over Past Experiences- Picture Courtesy: ZipRecruiter

Review old installation protocols and documentation for the same device within the facility. This review can uncover frequent installation problems, which leads to proactive modification within the protocol.

Define Acceptance Criteria

Define Acceptance Criteria

Instead of specifying that the instrument must be configured according to manufacturer guidelines, you should precisely describe your quantifiable and specific approval criteria for every roadblock in installation. It clears any vagueness and ascertains that validation auditors empirically evaluate compliance.

Take into Account Future Flexibility

Take into Account Future Flexibility- Picture Courtesy: 35 North

It is best to plan the installation qualification protocol by considering future instrument upgrades or adjustments. A modular section in documentation helps in quick and effortless updates, which decreases the necessity of rewriting the whole document later on.

Utilize Visual Aids

Utilize Visual Aids

Ideally, illustrations, flowcharts, and, pictures should be included in the installation qualification example protocol to improve the clarity of installation guidelines and expectancies. This aids in easier understanding and implementation from technicians and validation teams. Visual aids- for example, comprehensive wiring figures- guide technicians and decrease installation errors.

Strategize for Environmental Factors

Strategize for Environmental Factors- Picture Courtesy: Renejix Pharma Solutions

Consider and plan for the effect of environmental settings (temperature, humidity, air) on installation steps. Incorporate any expected environmental controls- like keeping the temperature under the required limit – and inspections to guarantee that these conditions do not severely impact the equipment installation and operation.

8.How to troubleshoot frequent errors during installation qualification example?

Experienced people admit that installation qualification is a challenging job. Resolving these challenges is a crucial job in the validation process to ensure that the instrument is correctly installed, otherwise next stage of validation does not occur.

So, let’s discuss these frequent errors and their solutions during the installation qualification example:

Improper Utility Connections

Improper Utility Connections

The instrument does not start because of an incorrect or insufficient connection with electricity, water, gas, etc.

Troubleshooting

Look through the manufacturer’s guide for electric current, pressure, and, water flow to ascertain these utilities are properly connected. Manually examine connection points to verify they are connected with matching inlets or outlets. To test gas lines or compressed air connections, it is advised to use a pressure gauge. Moreover, a multimeter should be utilized to assess electric assembly. The utility diagram of the factory or laboratory should match with equipment requirements, if not then update it.

Component Misalignment

Component Misalignment

Sometimes, during the installation, mechanical parts, for instance, drives, sensors, conveyor belts, pressure valves, and more are incorrectly aligned or assembled.

Troubleshooting

First, physically locate any misaligned or loose components, for instance, belts, and gears, then dismantle those parts, and reinstall them correctly and tightly as per manufacturer specifications. It is advised to use precision orientation devices like a ruler, dial indicator, and laser leveling tool to correctly position and level components. Inspect different bolts, screws, nuts, and other rivets, to properly secure them.

Inaccurate Calibration

Calibration in Installation

Different accessory devices like temperature sensors, pressure gauges, piston gauges, and gas piston meters have inadequate, or unverified calibration ranges. Sometimes, these instruments are found out of calibration during installation qualification.

Troubleshooting

To address this challenge, you should first look for valid calibration certifications for every vital piece of equipment and if they are outdated then renew their calibration. If required, you must carry out in-house calibration with standard calibration reference. Also, document every calibration outcome in the installation qualification protocol and note any anomaly and actions performed to encounter during this process.

Unsuccessful Safety Assessment

Unsuccessful Safety Assessment- Picture Courtesy: Fluke Corporation

During installation qualification, there comes a time when safety components, such as emergency stop buttons, alarm lights, interlocks, gaskets, and valves fail to meet safety criteria because they are non-functional or incorrectly fitted.

Troubleshooting

To rectify this installation error, inspect wiring and other connections of different safety features, and verify that they are wired and assembled properly according to the manufacturer's standards. Activation of safety instruments should be checked by inducing unsafe settings in the facilities. Replacement of faulty instruments must be carried out with certified components. Last but not least, it is suggested to contact the manufacturer for troubleshooting support if the device still fails to work after following the above instructions.

Labeling Slipups

Labeling Slipups- Picture Courtesy: Marcajes Telleria

Systems or other crucial devices are not correctly labeled, or have missing identification tags, causing mix-up during processing or maintenance.

Troubleshooting

It is recommended to solve this issue by going along with these suggestions like cross-checking the labeling stipulations from the installation qualification with manufacturing standards. Place correct, long-lasting, and, clear labels or tags on every part, utility, wiring, or piping. Installation qualification documentation should be updated to indicate precise labeling items for the upcoming review.

Conclusion

Installation qualification example in an integral procedure in the validation process to confirm proper installation, configuration, and functioning of any system, equipment, component, and, software. By following the step-by-step instructions and complying with the best practices mentioned in this blog post, you can efficaciously and lucratively conduct installation qualification examples, mitigate installation and operational mistakes, and satisfy stringent regulatory standards for your business and facility. Now, if you are keener on learning about installation qualification protocol for validation of routine industrial devices, you are highly encouraged to contact Allpack through our messaging or email service.

Don't forget to share this post!

CONTACT US

Tell us your raw material and project budget to get quotations within 24 hours.

WhatsApp Us: +86 181 7101 8586

The Buyer's Guide

Want to get Best Price Viscosity Tester from China?

Tell us your material or budget, we'll reply you ASAP within 24 hours

Installation Qualification Example: The Complete FAQ Guide In 2025 Read More »

DQ, IQ, OQ, PQ In FDA-Regulated Industries: The Complete FAQ Guide In 2025

Pharmaceutical Standard

DQ, IQ, OQ, PQ In FDA-Regulated Industries: The Complete FAQ Guide In 2025

Have you ever heard of DQ, IQ, OQ, or PQ? In FDA-Regulated industries, every piece of equipment and system is hooked to proper regulations. This means each step and protocol is jotted down in specified protocols. Why is it required to have verified documentation? What happens if your equipment is missing functional specifications?

In this article, we have talked about from basic to advanced literature about DQ, IQ, OQ, PQ in FDA-regulated industries. Stay on this page if you have less time and more questions in mind. We have explained the topic with interactive illustrations and examples to make you learn about these important certifications required in FDA regulated industries.

Add a header to begin generating the table of contents

1.What are DQ, IQ, OQ, PQ In FDA-Regulated Industries?

FDA

DQ, IQ, OQ, PQ in FDA-Regulated Industries

To understand the answer, you should first grasp what are FDA regulated industries. Actually, FDA is mainly meant to ensure safety and protection. Especially when it comes to dealing with medicines, biologicals, and items associated with health and medicine. Therefore, it is particularly important when you’re producing goods for foods, humans, pets, etc.

So, the FDA or Food and Drug Administration USA has regulated some essential rules and regulations; and is responsible for maintaining them.

In the pharma industry, you cannot deny accuracy and safety. You should know that any slight mishandling or error can cause potential hazards to patients. Subsequently, the reliability of equipment is paramount. DQ, IQ, OQ, PQ in FDA regulated industries is providing a promising way that certifies the current equipment and procedure is compiled with reliable performance and results and ensuring client safety.

2.What is DQ?

DQ- Picture Courtesy: MGA Techonology

This is ‘design qualification’ which is utilized in several industries like pharmaceuticals. It ensures that the system design is exactly according to regulated specifications. The DQ is mainly carried out when you are at the beginning of any project development; that promises you the machine is up to the mark with high-quality standards.

The DQ is associated with deep evaluation of design documentation involved with specifications and structural framework of the equipment. Hence it certifies that the design is complete with all possible essential documentation.

The prime objective of DQ is to immediately identify the structural flaws of equipment. Side by side, it ensures that equipment is compliant with FDA regulations and the establishment of the records relevant to the unit.

It is involved with the needs of users as well as user specifications. That requires a detailed design format with review and approval of the machine by various personnel such as engineering teams, quality analysts, and stakeholders. Test and simulation and risk analysis (safety features), record keeping, and final approval.

3.What is IQ?

Installation qualification- Picture Courtesy: Access Industrial Solutions

So, once you confirm that the design qualification of equipment is up to the mark therefore the next task is the installation of the unit. Do you know how your system implements the experimentation? It is all based on the right installation.

FDA-regulated industries mainly focus on IQ whenever install a piece of new equipment and it is called an ‘Installation Qualification’ or IQ. It is actually a verification document that certifies that your system is qualified and configured as it is promised in its specification. For that, you can mostly refer to the installation checklist mentioned in the manual of the machine-generated by the manufacturer.

Moreover, the IQ that is involved with methods should be well-documented and included in the ‘Validation Master Plane’ or VMP.

The compulsory steps involved for IQ are mainly outlining the methods and conducting assessments. That is mainly involved with the verification of the machine and things associated with it. It is included with the specifications given by the manufacturer. Moreover, the installation conditions such as area and temperature around the equipment, electrical essentials, and software installation.

4.What is OQ?

Operational Qualification- Picture Courtesy: Tien Tuan Pharmaceutical

Whenever you check IQ, it is parallel to performing the OQ or operational qualification of the equipment. As its name shows, it is an assessment to analyse the operational performance of the equipment as per your needs. The purpose of this verification is to ensure that whatever your manufacturer claimed is really performing in your functional range. This means it is mainly performed to identify the properties of the unit and ensure its seamless operation.

To perform this test, the plan sheet provided by the manufacturer or regulated body is properly checked and accepted by the facility once the test is successfully conducted.

The essential steps for OQ involve a thorough inspection of the unit. It means, the inspection of software and hardware, how to start and run the test, and assessing the safety protocols. Moreover, the test run is conducted to ensure that the machine is providing you the fruitful results hence you can confidently run the machine hereafter.

5.What is PQ?

Performance qualification- Picture Courtesy: Contract Pharma

This is the final step which is assuring the absolute functional capability of the equipment. The performance qualification or PQ promises you that the unit will offer a consistent output for a long period of time.

The pharmaceutical industry considers PQ as a major asset. Consistency and high throughput are what every pharma looks for to generate high-production batches and meet healthcare needs. Therefore, the test ensures that the functionality, installation, and efficacy of the machine are up to regulatory standards.

6.Why DQ, IQ, OQ, PQ In FDA-Regulated Industries is essential?

Every FDA-regulated industry like medicine, pharmaceuticals, research, biologicals, and others cannot work without addressing specified compliance requirements. So, there are multiple reasons to implement DQ, IQ, OQ, PQ in FDA-regulated industries. What are those points? We have discussed them below so have a look at them.

You Can't Ignore FDA regulations

FDA regulated Protocols

As per FDA statement in 21 CFR Title 211.63, the equipment utilized for processing, packaging, and overall manufacturing of medicinal items must be in accordance with the correct in structure, and sizes, and up to suitability of the facility to bring operation and for cleaning as well as maintenance. So, it is the responsibility of the manufacturing company to bring you unit with up-to-the-mark features.

It should be provided with detailed instructions and usage properties. That includes how to operate, clean, and maintain the unit to give it an effective application.

Make Patients Safe & Ensure Quality Product

Safe and quality preparation- Picture Courtesy: Makinew

When you’re manufacturing any medicine or product in your plant; slight mishaps, mishandling, or problems in the unit can lead to severe consequences for you and the patient. This is commonly referred to that equipment which is new without any history. Therefore DQ, IQ, OQ, PQ in FDA regulated industries make you pretty safe from failure in performance or error in the making of medications.

It creates everything in well-documented pieces of evidence and verifies the hardware and software of the units. So, what’s next? It makes lesser chances of incorrectness and makes you ensure that equipment is passed with design till its final performance with reproducible output. Thus, you can ultimately get a good quality product.

Your Facility is Compliant

Quality standards- Picture Courtesy: Microsoft news

Every pharmaceutical industry must be compliant with FDA regulations. Following the documentation for equipment installation meets all needs that are set up by FDA. The verification for DQ, IQ, OQ, PQ in FDA regulated industries ultimately minimizes the chances of batch withdrawal or recalls and saves your budget.

No Failure and Early Management

Minimize interruption- Picture Courtesy: WIPO

Every manufacturing industry keeps processing its protocols 24/7. Hence, there are high chances of failure. The strict adherence of DQ, IQ, OQ, PQ in FDA regulated industries helps you in the identification of issues at the beginning.

When you consider DQ, it assures you that the purchase unit is strictly designed with quality standards. Similarly, IQ, OQ, and PQ assessments are thorough testing assuring everything about the processing and future protocols.

Therefore, once you’re well aware of every stage will have high confidence in operating, identification of problems, and early troubleshooting.

Record Keeping

Verified data- Picture Courtesy: Vaisala

Implementation of DQ, IQ, OQ, PQ in FDA regulated industries allows verified records related to equipment from its making to processing. You can easily trace the history required for various activities in pharmaceuticals and related companies. So, you can have a clear picture with easily identifiable issues about the unit.

Offering Good Training and Knowledge

Good knowledge- Picture Courtesy: Technopharm

Bringing a new setup into your facility will allow your employees to facilitate training and gain good knowledge during the DQ, IQ, OQ, PQ approach. By this, a group of workers understands the protocols, relevant troubleshooting, and extensive knowledge that ensures your team is well aware of the work process and handling.

Good relationships with Vendor

Good relationships with vendor- Picture Courtesy: Pharmaceutical Technology

During DQ, IQ, OQ, PQ, and verification, you may discuss general matters and discussion about equipment closely. It directly opens the gateway between you and the vendor and can carry it out for long-term professional relationships.

7.What type of sectors utilizes DQ, IQ, OQ, PQ In FDA-Regulated Industries?

You cannot ignore the implementation of DQ, IQ, OQ, and PQ in FDA-regulated industries. What are those industries? Let's discuss how each of these plays a significant role with examples accordingly.

Pharmaceutical Industry

Pharmaceutical equipment- Picture Courtesy: Korber Pharma

This is the major core to produce medicines. Whether oral, parenteral, topical, or powder medicines; a minor error can result in risky outcomes. It directly affects your expenditure and delay in processing. Therefore, whenever a new set of equipment is installed in a pharma facility.

The series of tests DQ, IQ, OQ, and PQ are followed to ensure conformity with regulatory standards. This general qualification activity guarantees that the manufacturing process satisfies all requirements and provides you with quality products.

Biotechnology Industry

Biotechnology assays- Picture Courtesy: faCellitate

In the biotechnology industry, absolute working is needed when dealing with delicate assays, sampling, and cell culture procedures. The necessities for DQ, IQ, OQ, PQ are paramount as the functioning equipment for biotechnology tasks ensures reliable and efficient performance.

Due to conduction with sensitive testing related to genomic alteration, molecular level, cellular level, and blood sampling in biotechnology; the safety, effectiveness, and purity must be maintained by strict following up of FDA regulations.

Medical Devices Industry

Medical Devices Industry- Picture Courtesy: SJRA

It is essential to qualify the equipment used for manufacturing and packaging procedures for the medical devices industry. However, under real conditions of production, it will deliver medical devices and parts with high quality, thereby, the products manufactured will be totally safe for patients and end-users. For example, X-ray machines, CT- Scanner, implantation devices, or radiology medical equipment.

Food Industry

Food industry- Picture Courtesy: Redline

In the food sector, safety related to raw ingredients, manufacturing, filling, and packaging plays a significant role. For this, your equipment must have adhered to DQ, IQ, OQ, and PQ documentation to ensure the system is well-functioning and compliant with regulatory requirements.

Nutraceutical Industry

Nutraceutical Products- Picture Courtesy: Market Research Intellect

Just like pharmaceuticals and food, the nutraceutical industry also undergoes strict testing and production of goods related to human consumption. Most of us the equipment used in nutraceuticals is derived from natural sources that offer wellness to you.

Therefore, DQ, IQ, OQ, and PQ confirm that the design of the machine conformed with all the requirements and conditions needed for manufacturing products under the required conditions.

Veterinary Industry

Veterinary Industry

There is a surging need for good quality veterinary products nowadays. This field of production is equally important as the above-mentioned FDA-regulated industries. The life and health of animals must be dealt with by medicines or energy-boosting products that are manufactured with strict conformities by regulatory bodies.

The DQ, IQ, OQ, and PQ documentation significantly emphasized that the current units used for the preparation of products, such as solid dosage, parenteral, or liquid formulation for your animals are safe and prepared by FDA-approved equipment.

8.How to execute DQ, IQ, OQ, PQ In FDA-Regulated Industries?

Typically, the pharma and related FDA-regulated industries focus on the following steps for the execution of DQ, IQ, OQ, PQ. For instance:

Design qualification- Picture Courtesy: GEA

DQ is mainly verified by the following three steps.

Step 1	Here, it involved double checking of ‘purchase order’ as well as the ‘user requirement specification’. In many cases, the purchase order is also termed as a ‘request for purchase’. The purpose of this step is to ensure that manufacturers agree to offer the following properties, specifications, and materials are mentioned in the document and well-engineered.
Step 2	This section is hooked to detailed design specifications of the equipment that must be compliant with the drawing as presented to their customers and provided with updated features.
Step 3	You can term it as the final step where you can have a deep inspection of the overall presentation of the product and prepare a summary related to the equipment.

Installation Qualification

The IQ process is verified by the following steps:

Step 1

In this step, you will need to check the identification of the new equipment that is involved with the series, model number, type, automation, brand, etc.

Step 2

It is involved with the series of equipment and the qualification system as the installation requirement provided by the manufacturer's specification.

Step 3

The entire favorable condition is verified by checking the temperature of the installation area, measuring the humidity level, monitoring the electrical connections as well as assessing the machine’s calibration. The final report is prepared once all evaluation is done.

Operational Qualifications

OQ verification is performed to ensure that the equipment is operating properly as specified by the manufacturer. There are the following steps to make a successful OQ processing.

Step 1	The detail of the system, its software and hardware, and its operation is evaluated to check if the operational specifications is compliant with FDA regulations.
Step 2	The step-by-step running of the machine is conducted out and various operating tests are carried that are highlight operation with surrounding conditions. Here, you can also create intentional failure situations and simulate the error modes to learn teamwork with troubleshooting for unexpected circumstances.
Step 3	The result is summarized by observing all major details and possible recorded deviations and the corrective actions. The elaboration of each step in OQ validates that the unit is reliable and highlights the various risks and handling to enhance operational comprehensiveness.

Performance qualification- Picture Courtesy: Chemtech

The performance qualification steps are:

Step 1

The real-time assessing tools are techniques are implemented to monitor the data by PQ execution, here you can integrate various sensors as well as utilize software to analyze critical parameters.

Step 2

Furthermore, process analytical technology or PAT is offered to assess the quality and performance of the system.

Step 3

Also, the process capacity and design protocols are considered to evaluate the final limit of the production requirements. For example, if your recent production is 50, so in the future if it reaches above 100 then the PQ conduction test would verify that the process would be successful without affecting the quality of products.

9.What are the challenges of maintaining and designing DQ, IQ, OQ, PQ In FDA-Regulated Industries?

With DQ, IQ, OQ, PQ In FDA-regulated Industries' usual strategies, you also encounter some challenges. We have discussed some major issues and their solutions.

Inadequate Planning and Scope Definition

Complex planning and scope

Problem

Solution

One of the major issues in initial planning is vague or ambiguous requirements to be addressed by qualification, which most often brings gaps in documentation and compliance.

Now, a very vague scope can introduce uncertainty in particular validation needs, and such things may eventually be left out of the qualification process.

therefore, stress over scope definition and clarity of requirements. Teams often compromise full documentation in order to meet very tight deadlines and miss all the critical steps.

Precise Requirements Definition
Engage with stakeholders as early as possible—quality assurance, engineering, and operations teams—to make sure that all requirements are clear and complete from the beginning so that all aspects of the validation process are understood by everyone involved.Clean Scope Documentation

Develop a Validation master plan (VMP) that defines the scope of qualification, objectives, timelines, and contact responsibilities for each phase of qualification.

The plan is supposed to be a roadmap that will cover the topic clearly and result in full compliance with standards that have been laid down by regulatory bodies.

Clearly defining the scope and involving stakeholders leads to reduced risks of compliance and documentation gaps for companies.

Requirement and Fulfilling of each Phase

Utilization of regulation- Picture Courtesy Pharmaceutical Processing world

Problem

Solution

Each qualification including DQ, IQ, OQ, and PQ has different requirements and expectations, thus making the general process somewhat complicated. Since regulatory bodies like the FDA have to issue constant upgrades, it can get complicated for organizations to keep up with new norms.

Standards and guidelines of regulatory agencies, which are very often updated, may leave some gaps in qualification as companies cannot update fast enough.

Risk-based approach
DQ, IQ, OQ, and PQ efforts should highlight the critical parameters and processes. Therefore, most risks need importance in the consideration that it complies with and is safe for the product being produced.Continuing Education and Training
Regular and continuing training programs should be implemented so that all personnel will be current on all regulatory requirements, best practices, and new or additional standards or guidelines issued by agencies such as the FDA.

Regular regulatory review
It should be set up to have a continuous process of reviews of changes in regulations and adapt qualification procedures accordingly to keep pace with the changes in standards and minimize the risk of nonconformity. Interpretation of these updates by a dedicated team or system would have been an immediate prerequisite for adaptation.

Data and Documentation Management Challenges

Data and Documentation Management

Problem

Solution

The DQ, IQ, OQ, PQ may generate huge amounts of data, making it very hard to manage accurately and in a timely manner, hence increasing risk for errors and delay in compliance.

Heavily documented needs can sometimes be incomplete, inconsistent, or simply inaccurate records. The lack of information about suppliers and manufacturers, coupled with the validation process, has hollowed credibility as well as compliance.

Advanced-Data Management Tools

Think then about the modern data management solutions that would simplify collection, storage, and analysis. Even the usage of electronic systems must improve accuracy, tracking, and reporting for requirements.

Document Management System

Secondly, a comprehensive document management system should be adopted and standardize formats of documents automatically, whereby all documentation processes are automated. This minimizes the chance for error and increases consistency, further simplifying retrieval and review during audits or regulatory checks.

Inadequate or Missing Reports

Report issues- Picture courtesy: Zamann pharma

Problem

Solution

Reports may be incomplete or lack clarity, hindering effective decision-making and compliance verification.

Report preparation templates

Implement the use of templates whereby all reports have full details, easy to communicate, and are in similar formats for easier understanding.

Inconsistent Systems and Protocols

Inconsistent Systems and Protocols- Picture Courtesy: EESS

Problem	Solution
In the present system, different departments follow one single procedure for validation. Most equipment types lack standard operating procedures for qualification and their results vary. It means that either the protocols are vague, wrong, or incoherently defined. Thus, inaccuracies are introduced within the qualification process.	Standard operating procedures (SOPs) Standardize all the SOPs. This shall include qualification for a uniform process and documentation across this will certainly assure consistency and rule out errors from the fragmented processes.

Continuous Monitoring and Review

Continuous Monitoring and Review

Problem

Solution

Maintaining control and oversight overqualified systems can be challenging, leading to potential lapses in compliance.

Standard Review Procedures

Implement a process of continuous monitoring and auditing so that the qualified system continues to remain in compliance with regulatory standards and operational requirements.

Conclusion

The path of adding new equipment in your medical facility, pharmaceutical, biotechnology, etc is absolutely striking with challenges. But if you follow the right strategy and ideal resources that are compliant with FDA regulation can limit the obstructions. We would suggest if you have any problem or need to seek some advice, then always approach the right solution and experts who can solve the complexities during the regulatory issues. Why not contact us? We are a team of advisory professionals and manufacturers who strive for your support and guidance. For more information or FDA-regulated equipment for your production line, contact the Allpack team now.

Don't forget to share this post!

CONTACT US

Tell us your raw material and project budget to get quotations within 24 hours.

WhatsApp Us: +86 181 7101 8586

The Buyer's Guide

Want to get Best Price Viscosity Tester from China?

Tell us your material or budget, we'll reply you ASAP within 24 hours

DQ, IQ, OQ, PQ In FDA-Regulated Industries: The Complete FAQ Guide In 2025 Read More »