Cleanroom glossary

Short, plain definitions of the grades, standards, fabric and garment terms that come up when you specify cleanroom apparel.

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ANSI/ESD S20.20: A standard for electrostatic discharge control programmes that protect electronic parts. It sets limits for wrist straps, flooring, work surfaces and static control garments. EN 1149-5 vs ANSI/ESD S20.20
Aseptic processing: Manufacturing a sterile product from sterile components in a controlled environment, without terminal sterilisation of the final product. Operators in these areas wear a full sterile gown.
Autoclave: A pressure vessel that sterilises items with saturated steam, commonly at 121 °C or 134 °C. Reusable cleanroom garments are usually autoclaved after laundering. Autoclave cycle life
Autoclave cycle life: The number of laundering and sterilisation cycles a reusable garment is designed to survive while still meeting its performance specification. Garments are tracked so they are retired on time.

Bootie: A knee-length or calf-length overshoe worn over cleanroom footwear, with the coverall leg tucked inside. Sterile booties are part of the Grade A and B gown. Cleanroom booties
Bouffant cap: A gathered, elasticated head cover that contains hair in lower grade areas such as Grade D and ISO 8 rooms. Head caps
Bound seam: A seam whose raw edges are enclosed by binding tape or folded construction so fibres cannot escape from cut fabric edges.

Carbon grid fabric: Polyester fabric woven with conductive carbon yarns in a grid, typically every 5 mm, so static charge dissipates across the garment. Stripe fabrics run the yarn in one direction only. Antistatic fabrics explained
Certificate of conformity: A document issued with a batch confirming the goods meet the agreed specification. QA teams usually require one for every delivery.
Charge decay: How quickly static charge drains from a fabric, measured in seconds. Shorter is better. EN 1149-3 is one test method.
Cleanroom: A room in which the concentration of airborne particles is controlled and classified, and in which other parameters such as temperature, humidity and pressure are controlled as needed.
Contamination control strategy: A planned set of controls, required by EU GMP Annex 1, that covers how a sterile site prevents microbial, particle and endotoxin contamination. Gowning and garments are part of it.
Continuous filament polyester: Yarn made from unbroken synthetic filaments. It sheds far fewer fibres than spun yarns or cotton, which is why it is the standard fabric for cleanroom garments.
Coverall: A one-piece suit covering the body, arms and legs, worn as the main cleanroom garment. Styles include stand-up collar and attached hood. Cleanroom coveralls

EN 1149-5: European standard for protective clothing with electrostatic properties, used where a spark could ignite a flammable atmosphere. The fabric must meet a surface resistance or charge decay requirement. EN 1149-5 explained
EU GMP Annex 1: The European guideline for manufacturing sterile medicinal products, revised in 2022. Section 7 sets gowning expectations for each cleanroom grade. Annex 1 gowning requirements

Filtration efficiency: The share of particles of a given size that a fabric stops when air passes through it, usually reported at 0.3 µm and 0.5 µm.

Gowning qualification: Training and assessment that shows an operator can put on cleanroom garments without contaminating them, often confirmed with microbial sampling of the gown. Repeated periodically. Gowning sequence
Grade A: The EU GMP zone for high risk aseptic operations such as filling and making sterile connections. Equivalent to ISO 5 for particles at rest and in operation.
Grade B: The background environment for Grade A in aseptic processing. ISO 5 at rest and ISO 7 in operation. Operators wear the full sterile gown.
Grade C: A clean area for less critical steps in sterile manufacturing, such as solution preparation. ISO 7 at rest and ISO 8 in operation.
Grade D: The lowest EU GMP clean area grade, used for support activities such as component handling. ISO 8 at rest.

Helmke drum test: A test that tumbles a garment in a rotating drum while counting released particles. Described in IEST-RP-CC003 and used to compare garments and track them over their life. IEST-RP-CC003 explained
Hood: A head cover that encloses hair, ears and neck, with the lower edge tucked into the coverall collar. Required as sterile headgear in Grade A and B. Hoods and masks

IEST-RP-CC003: The Institute of Environmental Sciences and Technology recommended practice on garment system considerations for cleanrooms, covering fabric, construction, testing and processing. IEST-RP-CC003 explained
ISO 13485: International standard for quality management systems for medical device organisations. Many pharma and device QA teams look for it when qualifying garment suppliers. Our quality system
ISO 14644-1: International standard that classifies cleanrooms by airborne particle concentration, from ISO 1 (cleanest) to ISO 9. Garments by ISO class
ISO 9001: International standard for quality management systems, covering how an organisation controls processes, documents and improvement.

Lint-free: Describes a material that releases very few fibres in use. In cleanrooms it usually means continuous filament synthetic fabric with sealed edges.

Particle shedding: Release of particles and fibres from a garment during wear. Low shedding is a core requirement for every cleanroom garment.

Reusable cleanroom garment: A garment that is laundered, inspected and usually sterilised between uses, for a defined number of cycles. Lower cost per wear and less waste than disposables at most volumes. How long reusable garments last

Sterile garment: A garment that has been sterilised, typically by steam autoclave or gamma irradiation, and kept in sealed packaging until use. Required in Grade A and B areas.
Surface resistance: The electrical resistance measured across the surface of a fabric, in ohms. Lower values mean charge spreads and dissipates more easily.

Undergarment: A lint-free top and trouser set worn under the coverall in place of personal clothing, to reduce particles from street clothes. Undergarments

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