Cleanroom Clothing: Coats, Boots, Hoods AND Coveralls

Cleanroom attire consists of four essential parts: cleanroom coats, cleanroom hoods, cleanroom boots, and cleanroom coveralls.

Each part of cleanroom clothing serves to block specific human contamination pathways within controlled areas.

The specific combination of cleanroom garments to be used is determined by cleanroom classification standards, not by preference.

iso 5 Grade A requires the use of sterile cleanroom coveralls.

ISO 7 and iso 8 allow for the use of re-usable cleanroom coats, cleanroom hoods, and cleanroom boots.

This information is concrete and unarguable according to GMP.

Cleanroom garments provide product protection from human skin flakes, hair, and micro-organisms.

The garments also provide worker protection from hazards.

EU GMP Annex 1 [1] and FDA 21 CFR Part 211.28 [2] consider cleanroom protective clothing as a crucial point in any process.

The lack of a hood border or open wrist can result in the whole aseptic batch rendered invalid.

Deiiang™ has been providing cleanroom garments and contamination management solutions since 2002 with over $160 million annual revenue expected for 2025 across more than 50 countries.

Jason Peng, the lead designer, has secured 12 cleanroom barrier technology patents as well as led the clothing testing projects in APAC relating to iso 14644-3.

This paper sets out the different categories of cleanroom clothing, the recycled versus disposable cleanroom garments, as well as the standards, procedures, and cleanroom clothing selection process.

Core Cleanroom Garment Categories: Coats, Hoods, Boots, Coveralls

Cleanroom garments can be classified into four main categories.

Cleanroom coats cover the torso as well as arms while cleanroom hoods contain particles from the scalp and face.

The cleanroom boots isolate the footwear while the cleanroom coveralls encapsulate the whole body.

The design of the garments is assessed based on the risk of contamination.

In a sterile environment that meets ISO 5 standards, it is crucial to wear approved cleanroom clothing made of sterilized materials and designed to contain integrated features such as hoods and booties.

For this purpose, the Deiiang line of products includes all necessary cleanroom protective clothing for the sterile zone.

This line includes polyester/carbon composite cleanroom coats, autoclavable booties, Grade A sterile hoods, and Class 100 coveralls.

However, different fields require different types of protection.

Pharmaceutical sterile filling requires the strongest protective barriers. Semiconductor fabrication requires ESD-safe products.

Food processing cares about durable covered cleanroom garments that can be cleaned and reused.

Cleanroom Coats and Outer Protective Layers

Cleanroom coats are the main barrier of the body in environments with low cleanliness levels.

They are the most popular cleanroom clothing items because they provide protection, comfort, and are quick to wear.

Snap button coats allow the user to put them on quickly. Tie button coats offer a customizable fit and less trapped particles in closure areas.

Deiiang polyester/carbon composite cleanroom coats are designed for ISO 7 and ISO 8 zones.

The conductive carbon provides ESD protection without hindering particle filtration.

In addition, users can choose between ESD options that include conductive cuffs and collar grounding points.

Standard polyester cleanroom coats have a 92% particle retention rate for 0.3µm particles after testing, according to testing done internally by Deiiang.

Deiiang polyester/carbon composite cleanroom coats attain a 95% particle retention rate while providing a static decay time of less than 0.1 seconds according to IEC 61340-5-1 specifications.

The major characteristics of cleanroom coats are the following:

• Snap-front or tie-front designs
• Elastic or knitted cuffs
• Stand-up or mandarin collars
• Use of polyester/carbon composite materials in ESD processes

Cleanroom Hoods and Respiratory Head Coverage

Cleanroom hoods protect from high particle-shedding areas located at the head and neck regions.

An uncovered human head can release thousands of particles per minute.

Choosing the right cleanroom hood is a key consideration for cleanroom garments.

A full-head cleanroom hood protects the whole head, including scalp, both ears, neck and chin, allowing only the face to show through.

A bouffant style hood covers only the top of the head and allows the neck and ears to remain uncovered.

Full-head hoods are required for cleanrooms with an ISO rating of 6 or better and bouffant hoods can be used in ISO 7 and 8 rated facilities.

According to on-site gowning audits conducted by Deiiang, 23% of facial contamination in Grade A cleanrooms is caused by misalignment between the hood and the mask.

To avoid gaps when moving the head or body, the facial opening must fit flush with the edges of the hood and the mask.

Deiiang Grade A sterile cleanroom hoods are designed and manufactured to work in harmony with masks and protective eyewear to prevent facial contamination.

Depending on the design, the hood should be tucked under the collar of the cleanroom coverall or the front part of the hood should extend over the wearer's shoulders.

There are various types of cleanroom hoods available, including:

• Full-head hoods or bouffant styles
• Face opening compatible with the mask and goggles
• Press stud fastening or tie at the back
• Available in sterile and non-sterile types
• Compatible with eyewear

Cleanroom Boots and Contamination-Controlled Footwear

The importance of footwear as a source of contamination is overlooked.

Normal street shoes bring dirt and particles into the cleanroom and boot soles of normal shoes shed particulates with each step.

Cleanroom boots are essential for eliminating these sources of contamination.

Overboot types fit over the regular shoes worn in the facility and need to be replaced regularly.

Full boots are designed to completely ｒｅｐｌａｃｅ the street shoes and offer better containment against particulates falling through the soles.

Deiiang autoclavable cleanroom boots are able to be sterilized multiple times.

The slip-resistant ESD soles comply with IEC 61340-4-3 resistance requirements of between 1.0×10^5 and 3.5×10^7 ohms.

According to Deiiang's internal tests, Deiiang cleanroom sole designs are able to capture 98% of 0.5µm floor particles under simulated walking conditions.

ESD resistance remains within specification limits after no less than 50 autoclave cycles, according to internal validation tests performed by Deiiang.

Options for cleanroom boots include:

• Overboot or full boot style
• Specialized ESD sole with non-skid feature
• Autoclavable or gamma sterilizable options available
• Choice between reusable or single-use disposable
• Sole particle retention design

Cleanroom Coveralls and Full-Body Garment Systems

Cleanroom coveralls provide complete cover from neck to ankle. They eliminate the space between the lab coat and pants that can expose skin and underwear.

The standard design includes a zipper closure with a guard flap that seals off the area from particles escaping from the zipper.

This flap also assures two points of protection at a very critical point in the gown.

Inappropriate size selection accounts for 18 percent of wrist and ankle gaps found in Deiiang client gowning compliance audits due to inadequate sizing for their cleanroom garments.

Deiiang has 12 different sizes available with adjustable cuffs and ankle ties to make sure that there are no gaps when the user is moving around in the gown.

Deiiang class 100 cleanroom coveralls are appropriate for use in ISO class 5 cleanrooms.

Available with hoods and boots attached so that all gowning steps can be performed at one time without having any seams exposed.

Sterile validated cleanroom coveralls are necessary in Grade A and B areas of production, with documentation of particle shedding mandatory.

Handling of cleanroom garments after sterilization must take place so that the garments do not become contaminated again, as required by EU GMP Annex 1 Paragraph 7.13 [1].

Reusable vs Disposable Cleanroom Garments: Comparative Analysis

Choosing between reusable vs disposable cleanroom garments has an impact on costs, contamination risks, and environmental footprint.

Neither option is superior; each option provides advantages that depend on the type of cleanroom being used, type of production being processed, and facility infrastructure.

Overall, this means that the costs associated with reusable cleanroom garments may be higher initially, but when amortized over time, the reusable garments become less expensive than the disposable options.

The disposable cleanroom garments have a lower cost of initial purchase, but the cumulative cost is high with every use.

The risk profiles are different. Reusable cleanroom garments are based on validated laundering and sterilizing processes. On the contrary, the disposables have low contamination because of cross-contamination prevention.

The validation process of laundering is an essential aspect of reusable types of cleanroom clothing.

It was reported that the efficiency of particle removal decreased by more than 13.9% after using the garments for about 50 decontamination cycles and more than 26.1% after 70 cycles.

Deiiang has two different types of cleanroom garments available. One of the options is polyester-carbon reusable cleanroom garments made for ISO 7/8, with the second option being the sterile disposable cleanroom coveralls for Grade A/B applications.

Side-by-Side Performance and Cost Comparison Table

Table 1: Comparison of Reusable vs Disposable Cleanroom Garments

It is possible to see the point of crossover.

If the reusable coat is purchased for $60 and it is used 75 times, it costs $0.80 per use.

By contrast, a disposable coat is available for $12 per coat which turns out to be $12.00 each time it is purchased.

In this case, the reusable option is much cheaper on a per-use basis, where it would be 15 times lower on a frequent basis.

Cost calculator element (text-based): Inputs are daily garment uses, annual operating days, and laundering labor cost per garment.

Outputs are 3 years of total cost of ownership of reusable and disposable cleanroom garments.

Formula: annual uses = daily uses × operating days.

Reusable 3-year cost = (initial cost × units) + (laundering labor × annual uses × 3) + replacement cycles.

Disposable 3-year cost = unit cost × annual uses × 3.

Use Case Recommendations for Each Garment Type

Reusable cleanroom garments are appropriate for high-volume Grade C and D operations.

Facilities that run three shifts every day with consistent sizing can benefit the most from the use of launderable programmes.

Disposable cleanroom garments are necessary for sterile Grade A and B areas.

There is no way for reusable alternatives to match the single-use sterility assurance needed for aseptic processing.

Disposable options are favored for short duration projects and for batches used in clinical trials.

With all of the validation criteria removed, there are fewer barriers to start-up.

Facilities that have been established for a long period of time that have designated gowning locations.

Deiiang recommends that hybrid alternatives be used instead of both in facilities with cleanroom grades that are different.

For example, one of Deiiang's customers, a semiconductor manufacturer, has been able to save 42% annually in their garment costs through the use of reusable cleanroom coats for their ISO 7 bays and disposable cleanroom coveralls for their ISO 5 fab zones.

Cleanroom Protective Clothing Standards and Regulatory Compliance

Cleanroom protective clothing functions under a global set of regulations.

The primary foundation for establishing compliance of garments in the cleanroom is validation based on the process categories involved, cleanroom classification being applied, and contamination risk levels in the facilities.

For instance, cleanroom garments verified as compliant for ISO 8 cannot simply be substituted in an ISO 5 process without further validation.

Validation of sterile garments mandates demonstrable proof of particle shedding, sterility assurance, and integrity of the package.

Deiiang has engaged third-party testing laboratories and provides particle test data and laundering documentation for audit purposes.

International Standards Governing Cleanroom Garments

[1] EU GMP Annex 1 (2023) calls for no human skin exposure and sterile lint-free cleanroom garments for Grade A/B cleanroom environments.

[2] FDA 21 CFR Part 211.28(a) demands that apparel used in drug production shall produce no particle shedding and will not compromise the drug products.

[3] iso 14644-1:2015 specifies that the barrier effectiveness of cleanroom garments must correspond to the classification of the cleanroom in terms of particles.

[4] iso 14644-3:2019 lays down the requirements for testing dynamic particle shedding from cleanroom garments worn on the personnel.

[5] USP <797> (2023) establishes standards relating to sterile compounding in pharmacy.

[6] PIC/S GMP Guide PI 001-3 (2022) establishes requirements for garment cleaning and cleanroom gowning procedures to be established.

Deiiang Garment Compliance and Grade Certification

Deiiang cleanroom garments have systematically matched materials for ISO 5, 6, 7, and 8 cleanrooms.

Garments available for use in ISO 5/Grade A/B include sterile cleanroom coveralls and cleanroom hoods.

Garments for ISO 7/8/Grade C/D include washable cleanroom coats and cleanroom boots.

Testing for dynamic particle shedding performance is always conducted in ILAC-accredited facilities and laboratories such as TÜV SÜD and Intertek, as per Deiiang validation criteria.

Audit documents will include test reports, certification of material tested, sterilization logs, and laundering reports.

Correct cleanroom gowning procedures for GMP Facilities

The correct cleanroom gowning procedures determine the effectiveness of cleanroom garments.

If not donned correctly, a sterile cleanroom garment can cause more contamination than it prevents, especially at the clothing-to-glove interface.

The main rule is not to touch the external side of a sterile cleanroom garment with bare hands.

Every subsequent step during the gowning process must ensure that the protection provided by the previous procedure remains intact.

Deiiang gowning room layouts have a distinct pattern of clean to dirty area.

The bench serves as the dividing line between clean and dirty areas.

People cross the bench after putting on cleanroom boots but before putting on the body clothes.

Step-by-Step Donning Sequence for Full Cleanroom Apparel

Hand hygiene is performed. Cleanse, dry, and disinfect your hands.

Cleanroom boots or overboots are worn. Sit on the dirty side of the bench.

Cleanroom coveralls or cleanroom coats are worn. Zip and seal flaps.

The cleanroom hood is fitted. Cover all of your hair, ensuring that your mask aligns with your face.

Don sterile gloves. Ensure that the glove cuff covers the coverall cuff.

Conduct a final mirror inspection. Ensure that every portion of your skin is covered.

The most common errors when donning cleanroom garments include open wrist and hood edges outside of the coverall collar, according to Deiiang client audits.

These mistakes can result in a 300 percent increase in particle count in the breathing zone in Grade A environments, according to Deiiang field data.

Printable gowning room 6-point compliance checklist for posting:

Doffing Protocols and Post-Use Garment Handling

Removing the equipment is done in reverse to how it was put on.

The alternative factor here is to ensure contact with the outer garment is avoided since it remains contaminated when it touches skin or outside clothing.

• Take off the gloves: take gloves off starting from wrist to fingers without making a snap
• Take the cleanroom hood off: do this by only using the inner surface of this hood
• Unzip the cleanroom coveralls or cleanroom coats using the inner side of the garment
• Remove the cleanroom boots: you have to sit down while doing so. Ensure that you do not touch the sole using your bare hands
• Hand hygiene should always be practiced after removing everything

According to Deiiang contamination control statistics, when you shake the garments while removing them, there can be more than 500 airborne particles per cubic foot released into the surrounding air.

All movements have to be slow and controlled in order to prevent contamination of clean areas and other personnel.

The reusable cleanroom garments have to be returned to the designated bin for validated laundering.

The disposable cleanroom garments have to be discarded for incineration.

Cleanroom Clothing Selection Guide for Facility Managers

If the attire meets the desired benchmark but does not offer good comfort, then it is most likely that it will not be properly worn.

Choosing the appropriate equipment to match the cleanroom category involves deriving the correct cleanroom category.

iso class 5 and Grade A/B is when a sterile, single-use or reusable, validated complete suit must be worn. ISO 7-8 and Grade C/D allow for using cleanroom coats, cleanroom hoods, and cleanroom boots.

Decision-making structure concerning cleanroom clothing selection:

• Confirm cleanroom grade (ISO 5 / Grade A-B vs ISO 7-8 / Grade C-D)
• Identify industry-specific hazards (ESD, biological, chemical)
• Calculate daily use volume to evaluate reusable vs disposable cleanroom garments economics

Deiiang makes it easy through having a tool that helps the right classification to be established so that the required cleanroom garment set could be determined.

Selection Criteria by Cleanroom Classification Grade

Table 2: Garment Requirements by Cleanroom Grade

The procedures of cleanroom garment selection must be based strictly on ESD cleanroom garments for all electrostatic-sensitive manufacturing and assembly operations.

cleanroom class c uses reusable cleanroom coats and cleanroom hoods, while class d cleanroom coats are basic.

When it comes to boot type, it must comply with the floor material.

Application-Specific Garment Selection by Industry

For sterile processing plants in the pharmaceutical industry, cleanroom garments must be sterile and include the use of gloves, masks, and goggles.

In Class A rooms, no skin can be exposed.

Cell and gene therapy facilities follow USP <1035> viral containment rules, requiring enhanced-barrier cleanroom coveralls.

Semiconductor manufacturing requires an ESD garment for controlling particulate contamination.

The use of conductive cleanroom garments and cleanroom boots can help to eliminate any static charge applied to wafers.

Flexibility is key, especially when it comes to laboratory R&D.

Horizontal garment systems consisting of interchangeable cleanroom coats, cleanroom hoods, and cleanroom boots will allow for quick response to alterations in protocol.

The food processing industry uses durable, reusable cleanroom garments and seeks compliance with FSMA regulations regarding hygiene, as well as preventing contamination from food products.

Specific packages for each industry will include garment type and fabric used, as well as document validation and certifications based on each industry.

Frequently Asked Questions

What is the main purpose of cleanroom clothing?

Cleanroom clothing keeps human-derived contaminants from entering the clean product. This means skin, hair, and germs.

All four core types – cleanroom coats, cleanroom hoods, cleanroom boots, and cleanroom coveralls – serve this core barrier function. Cleanroom protective clothing is also needed for GMP compliance.

How do reusable and disposable cleanroom garments differ?

Disposable cleanroom garments are meant for single use and disposed of after each time they are worn.

Reusable cleanroom garments are launderable and serve 50 to 100 use cycles.

Disposable cleanroom coveralls are preferred for sterile Grade A/B applications. Grade C/D operations tend to use reusable cleanroom coats and cleanroom boots.

Which cleanroom garments are required for Grade A areas?

Grade A application is done with sterile cleanroom coveralls that contain cleanroom hood and cleanroom boots.

Double sterile gloves, face mask and eye protection are also needed as part of the gowning procedure.

All cleanroom garments must have documented sterility and particle shedding validation.

What is the correct order for cleanroom gowning?

The cleanroom gowning procedure starts with washing the hands.

Cleanroom boots are put on first, followed by cleanroom coveralls or cleanroom coats, cleanroom hoods, and finally gloves.

A final visual inspection confirms complete coverage before entering the clean zone.

How often should cleanroom clothing be replaced?

Disposable cleanroom garments are changed after each use.

Reusable cleanroom garments are changed when they get to the number of washes specified in the validated laundering cycle or when there is visible damage.

Reusable cleanroom garments also require re-qualification testing after their rated cycle count to confirm barrier performance. Sterile batches expire after their labeled date.

Can I use regular work boots in a cleanroom?

No, regular footwear will cause uncontrolled shedding of particles and does not have the required anti-contamination features.

They can introduce contamination that violates GMP standards and jeopardizes product quality.

Dedicated cleanroom boots or cleanroom overboots are required in all classified areas.

References

• [1] EU GMP Annex 1 (2023), Manufacture of Sterile Medicinal Products, Paragraph 7.13. https://health.ec.europa.eu/document/download/3f7f8e5e-1e0a-4f6e-9d3e-8e0a0e6e0e0e_en
• [2] FDA 21 CFR Part 211.28(a), Personnel Responsibilities. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211/subpart-B/section-211.28
• [3] ISO 14644-1:2015, Cleanrooms and Associated Controlled Environments — Classification of Air Cleanliness.
• [4] ISO 14644-3:2019, Test Methods for Cleanrooms and Associated Controlled Environments.
• [5] USP <797> (2023), Pharmaceutical Compounding — Sterile Preparations.
• [6] PIC/S GMP Guide PI 001-3 (2022), Guide to Good Manufacturing Practice for Medicinal Products.