Certified cleanroom clothing for ISO 3 to ISO 9 & GMP A–D
Cleanroom clothing Cleanroom clothing encompasses all specially developed clothing systems designed to minimize the shedding of particles, fibers, and germs by humans in controlled environments. Humans are the largest source of contamination in cleanrooms, shedding up to 10 million skin particles per minute. Therefore, cleanroom clothing primarily protects the product from the wearer – and in certain applications (e.g., cytostatics, biotechnology), it also protects the wearer from the product. It is indispensable in the pharmaceutical, semiconductor, medical technology, food production, biotechnology, optics, and aerospace industries.
For HEIN Reinraum You will find a complete range of cleanroom clothing - from cleanroom overalls, Cleanroom gowns, Cleanroom hoods and mouthguard over Cleanroom overshoes and Cleanroom boots to Underwear, ESD protective clothing and sterile complete systemsAll products are available as Disposable cleanroom clothing (Disposable) or as Reusable cleanroom clothing (Reusable) – for cleanroom classes ISO 3 to ISO 9 and GMP A to D. We supply complete clothing concepts including advice on selection, training on correct donning and doffing, and connection to industrial laundry partners for validated reprocessing.
What types of cleanroom clothing are available? – An overview of garments
A complete cleanroom clothing system consists of several coordinated components. The selection depends on the cleanroom class, the process (aseptic, ESD-critical, chemically stressed), and GMP requirements.
cleanroom overalls
The Cleanroom overalls - also Cleanroom suit or body suit – is the central garment for highly classified areas (ISO 3–5, GMP A/B). It covers the entire body, fits snugly at the neck, wrists, and ankles, and features an integrated or attachable hood. Sterile coveralls are delivered individually folded, sterilely packaged, and gamma-irradiated (SAL 10⁻⁶).
cleanroom gowns
cleanroom gowns or Cleanroom lab coat These are the standard solution for lower cleanroom classes (ISO 6–9, GMP C/D). They are worn over street clothing and protect against moderate particle shedding. Models with stand-up collars, snap fasteners, or concealed button plackets further minimize particle dispersal.
Cleanroom hoods and head coverings
Cleanroom hoods They completely enclose the head, neck, and shoulders, preventing the shedding of hair and skin particles. For lower classes, Cleanroom beret hoods or Bouffant hoods for use. In GMP A/B areas, the hood is pulled under the collar of the coverall to create a continuous barrier.
Mouth and nose coverings and face masks
Specifically developed for cleanrooms mouthguard or Cleanroom masks They filter respiratory particles and reduce microbiological contamination. For GMP A/B areas, eye protection or full face shields are also used.
Cleanroom overshoes and boots
Cleanroom overshoes, Cleanroom boots or Cleanroom Boots They are made of low-particle materials (polypropylene, PE, PVC) and have non-slip or ESD-compliant soles. In high-security areas, they are pulled over the trouser legs of the overalls to form a closed barrier.
Cleanroom underwear and functional clothing
Cleanroom underwear Made from low-particle fabrics (e.g., polyester filament), it is worn under the coverall in GMP A/B areas and complements the clothing system. It reduces the migration of skin particles through the coverall and improves wearer comfort.
ESD protective clothing
ESD cleanroom clothing It is equipped with woven-in carbon or copper threads and dissipates electrostatic charges in a controlled manner. It is mandatory in semiconductor manufacturing, the electronics industry, and optics to protect sensitive components from electrostatic discharge (ESD). The EN 1149-5 standard defines the requirements.
Protective clothing against chemicals and biological agents
For applications involving cytostatics, active pharmaceutical ingredients (APIs) or biologically active substances, we supplement the cleanroom clothing system with chemical-resistant overalls (Type 3/4/5/6 according to EN 14605, EN 13982-1, EN 13034) or biological protective suits (EN 14126).
Disposable vs. reusable cleanroom clothing
A key selection criterion is the decision between disposable and reusable clothing. Both systems have specific advantages and disadvantages that must be weighed depending on the cleanroom class, process, number of employees, and sustainability strategy.
| Criterion | Disposable cleanroom clothing | Reusable cleanroom clothing |
|---|---|---|
| Material | SMS, SMMS, Tyvek®, polypropylene non-woven fabric | Polyester filament, microfiber, possibly with carbon thread |
| acquisition cost | Low per piece | Higher per piece |
| Life cycle costs | Continuous, quantity-dependent | Lower per use (50–75 cycles possible) |
| POLISHING | Not applicable – one-time use | Validated cleanroom laundry required |
| environmental Accounting | Higher waste volume | Reduced material consumption, water/energy consumption through laundry |
| Logistics | Storage, disposal | Laundry logistics, tracking system (RFID) |
| Typical application | Pharmaceutical sterile areas, visitors, fluctuating occupancy | Semiconductor industry, continuous production, ESD areas |
Cleanroom clothing according to ISO and GMP classification
The choice of clothing system depends on the cleanroom class according to ISO 14644-1 and the GMP classification according to EU-GMP Annex 1 (2022)The lower the ISO class (= purer), the more complete and dense the clothing system must be.
| ISO class | GMP class | Recommended clothing system | Sterility | Typical application |
|---|---|---|---|---|
| 3–4 | A / B | Sterile coverall + hood + mask + goggles + overshoes + cleanroom underwear | Sterile, individually packaged | Aseptic filling, sterile manufacturing, isolators |
| 5 | A / B | Sterile coverall + hood + mask + overshoes | Sterile | Pharmaceutical sterile production, medical technology |
| 6 - 7 | C | Coverall (non-sterile) + hood + face mask + overshoes | Non-sterile, low particle count | Pharmaceutical support areas, biotechnology, optics |
| 7–8 | D | Cleanroom gown + bouffant cap + overshoes | Not sterile | Packaging, storage, preparation areas |
| 8–9 | Smock or simple protective clothing + hood | Not sterile | Electronics manufacturing, general controlled areas |
What are the key considerations for cleanroom clothing?
Particle emission and Helmke drum test
The particle emission from cleanroom clothing is determined according to the Helmke Drum Test (IEST-RP-CC003) tested. In this test, the garment is subjected to mechanical stress in a rotating drum, and the released particles are measured. Classifications range from Class I (very low particle release, suitable for ISO 4–5) to Class IV (high particle release, ISO 8–9). For reusable garments, the classification decreases with each reprocessing cycle – validated laundry partners document the number of cycles using an RFID chip.
Filtration efficiency and material density
Filtration efficiency describes what proportion of the particles emitted by the body are retained by the fabric. High-quality cleanroom fabrics achieve values of 99–99,9% for particles ≥ 0,5 µm. Materials such as Tyvek® (Flashspun polyethylene), SMS (spunbond-meltblown-spunbond) or Polyester filament with microdenier threads offer high filtration efficiency while remaining breathable.
Comfort and breathability
Cleanroom clothing is often worn for several hours. Breathable materials (e.g., microporous membranes, breathable SMS nonwovens) reduce heat build-up, increase employee acceptance, and thus compliance with SOPs.
Sterility (SAL 10⁻⁶)
Sterile cleanroom garments are sterilized by gamma irradiation after manufacturing and packaged in a cleanroom environment (ISO 4-5). A SAL value of 10⁻⁶ means a probability of 1 in 1.000.000 that a garment will still carry viable microorganisms after sterilization – standard for GMP A/B.
ESD protection (EN 1149-5)
ESD-compatible cleanroom clothing with woven-in carbon threads (typically 5 mm or 10 mm grid) dissipates electrostatic charges in a controlled manner and is mandatory in semiconductor manufacturing, optics and electronics production.
Chemical and biological agent protection
For applications involving hazardous substances, chemical-resistant coveralls conforming to EN 14605 (Type 3/4 – liquid-tight/splash-proof), EN 13982-1 (Type 5 – particle protection), and EN 13034 (Type 6 – limited splash protection) are used. Biological protection is classified according to EN 14126.
How to put on cleanroom clothing correctly – The dressing protocol
The correct gowning procedure is a critical step in cleanroom operations. Errors during gowning can jeopardize the entire cleanroom concept. Gowning takes place in an airlock with clearly separated areas (unclean/transition/clean) according to a documented Standard Operating Procedure (SOP):
- Preparation in the unclean area: Remove street clothes, take off jewelry, wash and disinfect hands.
- Cleanroom underwear and, if necessary, put on cleanroom socks.
- Cleanroom shoes or boots put them on, making sure not to exceed the transition area when changing shoes.
- Hood and face mask Apply – completely cover hair
- Sterile coverallOpen the packaging in a clean area, put on the coverall by touching the inner surfaces without touching the floor.
- Cleanroom gloves pull over the cuffs of the overalls
- Overshoes / boots Pull over the legs of the overalls, attach the fastener.
- Mirror check – Check fit, fasteners and complete coverage
- Disinfect your hands Enter with sterile disinfectant and cleanroom
Standards and certifications for cleanroom clothing
- ISO-14644 1: 2015 – Classification of air cleanliness in cleanrooms
- ISO-14644 5: 2004 – Cleanroom operation (including clothing)
- EU-GMP Annex 1 (2022) – Production of sterile pharmaceuticals
- IEST-RP-CC003.4 – Garment Considerations for Cleanrooms (Helmke Drum Test)
- EN ISO 13688 – Protective clothing – General requirements
- EN 14605 – Protective clothing against liquid chemicals (Type 3/4)
- EN 13982-1 – Protective clothing against solid particles (Type 5)
- EN 13034 – Protective clothing against liquid chemicals (Type 6)
- EN 14126 – Protective clothing against infectious agents
- EN 1149-5 – Protective clothing with electrostatic discharge (ESD) properties
- EN ISO 11612 / EN ISO 14116 – Protection against heat and flames
- Regulation (EU) 2016/425 – Personal protective equipment (PPE)
Why cleanroom clothing from HEIN Reinraum?
- Complete product range: Overalls, gowns, caps, masks, overshoes, boots, underwear – disposable and reusable for ISO 3 to ISO 9 and GMP A to D
- In-house testing laboratory: Testing of particle emission (Helmke drum), ESD properties, chemical resistance and sterility
- Validated laundry partners: Connection to industrial cleanroom laundries for validated processing of reusable clothing including RFID tracking
- Assembly and logo printing: Customization of cleanroom overalls and gowns according to customer requirements
- Personal expert advice: Selecting the optimal clothing system for your cleanroom class, GMP requirements and number of employees
- Sampling: Free samples for testing in your own cleanroom environment
- Training: Practical training on correct dressing and undressing (gowning training) at your location
Frequently Asked Questions (FAQ) about cleanroom clothing
Cleanroom clothing (also known as cleanroom apparel or cleanroom garments) is specially designed protective clothing for use in controlled environments (cleanrooms). It minimizes the release of particles, fibers, and germs by the wearer, thus protecting the product from contamination. Cleanroom clothing includes coveralls, gowns, caps, face masks, overshoes, boots, and cleanroom underwear, and is available in sterile and non-sterile versions for cleanroom classes ISO 3 to ISO 9 and GMP A to D.
For ISO Class 5 and GMP Grade A/B, a complete sterile clothing system is required: sterile coverall with integrated or attachable hood, sterile mask, sterile goggles (if required), sterile overshoes or boots, and cleanroom underwear. All components must be individually sterile-packed and have a sterility assurance level (SAL) of 10⁻⁶. Donning and doffing are performed in a validated airlock according to a documented standard operating procedure (SOP).
The decision depends on several factors: Disposable cleanroom garments (e.g., made of Tyvek® or SMS nonwoven fabric) are ideal for fluctuating workloads, for visitors, or in sterile pharmaceutical areas where reprocessing is not permitted or too costly. Reusable cleanroom garments made of polyester filament are more economical for continuous production (50–75 reprocessing cycles) and offer better breathability as well as integrated ESD protection. Reusable garments dominate in semiconductor manufacturing, while disposable garments are common in pharmaceuticals. A life cycle analysis shows that both systems can be economically and ecologically advantageous, depending on the application.
The Helmke drum test (according to IEST-RP-CC003) is the standard test method for measuring the particle shedding of cleanroom garments. The garment is subjected to mechanical stress in a rotating drum (15 rpm) for 5 minutes, while the released particles are measured with a laser particle counter. The result is expressed in particles ≥ 0,5 µm per minute and classified into four classes (Class I to Class IV). Class I is the cleanest class and suitable for ISO 4–5.
Reusable cleanroom garments may only be processed in validated cleanroom laundries. The process includes washing with deionized water and cleanroom-compatible detergents, rinsing, drying under cleanroom conditions (ISO 4–5), visual inspection for damage, creases, and sterile packaging – and, if necessary, sterilization by gamma irradiation or autoclaving. Each cycle is documented via RFID chip. After 50–75 cycles, the garments are typically retired. Reprocessing in standard industrial laundries or even at home is not permitted.
The clothing change frequency depends on the cleanroom class, process, and internal SOP. In GMP A/B areas, a change is required per shift or after each exit from the cleanroom. In GMP C areas, changes are often made daily, and in GMP D areas, upon visible soiling or at least weekly. In case of visible damage, soiling, or after contact with contaminated substances, an immediate change is always required. Disposable clothing is disposed of after each use in the cleanroom.
Disposable cleanroom garments are typically made of Tyvek® (flashspun polyethylene), SMS or SMMS (spunbond meltblown spunbond nonwoven), or polypropylene. Reusable cleanroom garments are made of dense polyester filament fabrics (often with 5 mm or 10 mm carbon fibers woven in for ESD protection). Both material groups are selected to offer high filtration efficiency (≥ 99% for particles ≥ 0,5 µm) while maintaining acceptable breathability and durability.
Prices vary considerably depending on the garment, material, sterility, and cleanroom class. Disposable coveralls made of SMS nonwoven fabric are available from approximately €3–7 each, while sterile Tyvek® coveralls for GMP A/B cost between €10 and €25 each. Reusable polyester coveralls cost €50–€150 each to purchase, but can be reprocessed 50–75 times – the cost per use is therefore often lower than that of disposable clothing. Cleanroom gowns start at approximately €5 (disposable) or €30 (reusable), and sterile caps and overshoes cost approximately €0,30–€2,50 each.
Cleanroom clothing must meet various standards depending on its application: ISO 14644-1 (cleanroom classification), ISO 14644-5 (cleanroom operation), EU-GMP Annex 1 (sterile pharmaceutical manufacturing), IEST-RP-CC003 (Helmke Drum Test), EN ISO 13688 (general protective clothing), EN 14605 / EN 13982-1 / EN 13034 (chemical protection type 3–6), EN 14126 (infection control), EN 1149-5 (ESD protection), and Regulation (EU) 2016/425 on personal protective equipment. Specific compliance with these standards is documented in the product data sheet.
A complete cleanroom clothing system for GMP A/B consists of: 1) cleanroom underwear made of low-particle polyester, 2) cleanroom socks, 3) sterile coverall with cuffs, 4) cleanroom cap or integrated hood, 5) face mask, 6) safety goggles or full face shield (depending on the process), 7) sterile cleanroom gloves (often in a two-glove system), 8) sterile overshoes or boots. All components must be coordinated to create a continuous, tight barrier without any exposed skin.
ESD cleanroom clothing is equipped with woven-in carbon fibers (typically in a 5 or 10 mm grid) and dissipates electrostatic charges in a controlled manner. It protects sensitive electronic components in semiconductor and electronics manufacturing from damage caused by electrostatic discharge. The requirements are defined in the EN 1149-5 standard. ESD clothing is used in conjunction with ESD shoes, ESD gloves, and a grounded workstation.