Cleanroom PPE – Guide & Selection by ISO Class
Your complete clean room PPE guide — a clear path to choosing certified protective equipment for each ISO class, tailored to your process and risk profile.
Medicom highlights verifiable compliance, full traceability, and proven performance. The goal? Protection you can measure and trust.
Risks & Standards in Controlled Environments
In a cleanroom, the main risk often comes from within — the operator. Hair, skin, and even breath are invisible carriers of particulate contamination. Add to that biological risks (microorganisms), chemical exposure (solvents, powders), and electrostatic discharge (ESD) capable of damaging sensitive components.
Each protocol follows strict benchmarks: ISO 14644 for airborne particulate control and ISO classes, or GMP zones A/B/C/D in pharmaceutical environments. The rule is simple yet absolute: the right PPE safeguards both the operator and the product.
Quick Selection Guide
How do you navigate the full range of clean room PPE? The most efficient method is to cross-reference three key factors: environment (ISO class or GMP zone), operation (production, cleaning, maintenance, quality control), and risk type (particulate, biological, chemical, ESD).
This matrix approach turns a complex process into a clear, actionable choice. In short, it’s your cleanroom dressing guide — designed to save time and reinforce process integrity.
| Class / Zone | Main Risk | Recommended PPE |
| ISO 5 / Zone A | Aseptic, sterile | Sterile head covers, cleanroom masks, sterile coveralls, long gloves, low-shedding overshoes, antistatic accessories |
| ISO 7 / Zone B-C | Particulate, chemical | Cleanroom coats, sterile/non-sterile nitrile gloves, non-slip overshoes, FFP masks for technical zones |
| ISO 8 / Zone D | Dust, maintenance | Type 5/6 coveralls, nitrile gloves, FFP2/FFP3 masks, cuffs as needed |
This matrix is only a starting point; the final choice must incorporate your internal protocols and applicable regulatory requirements.
Table taken from the ASPEC guide “Cleanroom clothing” based on recommendations IEST-RP-CC-003.5 & IEST-RP-CC027.2 of ISO 14644-5 and the new Annex 1 of BPF-GMP.
| Areas of activity | Pharmacy, Medical, Medical Devices, Biotechnology, Cosmetics | Microelectronics, Space, Optics, Aeronautics, Precision Mechanics | Food Industry | |||||||
| Grade / ISO Class | A/B | C/D | ISO 4 | ISO 4 / ISO 1 | ISO 5 | ISO 6 | ISO 7 | ISO 5 | ISO 7 | ISO 8 |
| Underwear | M | M | R | R | R | SA | SA | R | SA/ | NS/ |
| Headpiece | M | AS | R | R | R | SA | SA | R | SA | SA |
| Headgear | M | R | R | R | R | R | SA | R | SA | SA |
| Glasses / Goggles | M | SA | R | R | R | R | SA | R | SA | SA |
| Face Mask | M | R | R | R | R | R | R | R | SA | SA |
| Gown | NS | SA | NS | NS | NS | SA | R | NS | SA | R |
| Coverall | M | SA | R | R | R | R | SA | R | SA | SA |
| Glove | M | SA | R | R | R | R | R | R | R | SA |
| Shoecover | R | R | R | R | R | AS | SA | R | SA | SA |
| Overshoes | M | R | R | R | R | R | SA | R | SA | SA |
| Socks | M | R | R | SA | SA | SA | SA | R | SA | SA |
| Particulate decontamination | M | M | M | M | M | M | R | M | R | R |
| Sterilization | M | SA | SA | NS | NS | NS | NS | AS | NS | NS |
| Frequency of change | At each entry | Once a day | At each entry | At each entry | Once a day | 3 times a week | Twice a week | Once a day | 3 times a week | Twice a week |
M = Mandatory R = Recommanded SA = Specific Application NS = Not Suitable or only slightly Suitable
Head & Face Protection
Head and facial protection form the first line of defense against contamination. Head covers, hoods, and masks prevent hair, skin particles, or exhaled air from compromising environmental integrity.
Cleanroom Head Covers (Caps, Hoods, Bouffants)
As the first shield, Medicom head covers effectively retain hair and minimize particle dispersion. Available in several formats (caps, hoods, bouffants) and compliant with ISO protocols, they ensure low particulate release and meet the needs of both sterile and non-sterile zones.
Cleanroom Masks – ISO AIR® Range
Developed for critical environments, ISO AIR® masks combine Softex® technology with ultra low-lint materials. They guarantee filtration efficiency above 99% (BFE, PFE, VFE), validated before and after sterilization, and are suitable for ISO Class 3 / Grade A and above. Available in sterile (ETO ISO 11135) or non-sterile versions, with cross-head elastic straps for a secure fit.
FFP Masks – Kolmi® Oxygen Range
For technical or adjacent areas, Kolmi® Oxygen masks are certified to EN 149:2001 + A1:2009 and classified as Class I Medical Devices. Available in FFP2 and FFP3, they offer high-performance respiratory protection against solid and liquid aerosols. Made in France, some models feature up to 70% recycled materials (Mass Balance).
FFP Masks – SafeMask® Fit+Pro Range
Designed for maximum respiratory safety, the SafeMask® Fit+Pro line includes four FFP2 and FFP3 NR models — with or without exhalation valves — certified to EN 149:2001 + A1:2009 and compliant with EU Regulation 2016/425. Made in France, these masks combine exceptional breathability, ergonomic fit, and long-wear comfort. Their multilayer structure ensures efficient filtration of solid and liquid particles while reducing breathing resistance.
👉 FFP3 NR SafeMask® Fit+Pro Valve
👉 FFP2 NR SafeMask® Fit+Pro Valve
Body Protection (Cleanroom Apparel)
Cleanroom garments act as a protective barrier against particulate and biological agents while maintaining comfort and breathability. Medicom provides solutions for ISO 4–8 environments.
Cleanroom Coveralls – WeePro® Labo Range
Made from Micromium®, a low-linting, non-contaminating material, WeePro® Labo coveralls are available in sterile and non-sterile versions. Helmke Drum-tested, they ensure ultra-low particulate release.
-
Available types: Type 5 / Type 6 (solid particle and limited splash protection)
-
Options: with or without integrated boots, triple sterile packaging for SAS entry
-
Compliance: PPE Cat. III – EU Regulation 2016/425
👉 WeePro® Labo Chemical Coverall
Cleanroom Coats – WeePro® PB 6 Range
For ISO 7–8 zones, research, or QC environments, WeePro® PB 6 coats are made from low-lint fabrics for lightweight protection.
-
Features: jersey cuffs, breathable material, easy movement
-
Compliance: PPE Cat. III, Type PB [6] (limited liquid splash protection)
-
Sizes: M to XXL
Hands (Gloves & Sleeves)
Hands are the main point of contact with sensitive materials. Medicom offers nitrile, polymer, and sterile sleeve options to meet ISO 5–8 standards.
Nitrile Cleanroom Gloves – Kolmi® Coverfeel
Manufactured in France at the ManiKHeir site, Kolmi® Coverfeel® gloves combine elasticity, comfort, and high grip. Available in sizes XS–XXL, sterile and non-sterile, certified Class I Medical Device and PPE Cat. III. A long-cuff version (Coverfeel® Care Long) provides optimal overlap.
Neoprene / Polymer Gloves – SafeTouch® X’tra
SafeTouch® X’tra gloves are designed for the most demanding environments, featuring a 355 mm long cuff and double chlorination to minimize contaminants. Certified PPE Cat. III, they ensure strong chemical and particulate resistance — ideal for sensitive or nuclear labs.
Feet
Footwear is a major contamination source. Medicom’s cleanroom overshoes and overboots provide effective barriers while maintaining grip and comfort.
Overshoes – Kolmi® Isoguard / Skidguard
Made in France and tested with the Helmke Drum, these overshoes have low particulate release. The Skidguard model features a non-slip sole ideal for smooth or damp floors.
👉 SafeFeet Skidguard Overshoes
ESD Overshoes – SafeWear®
Equipped with a conductive strip, they dissipate electrostatic charges to protect sensitive components — perfect for microelectronics and high-tech labs.
Overboots – WeePro® Labo
Sterile WeePro® Labo overboots provide an effective barrier against contamination in controlled environments. Made from non-linting Micromium®, tested to Helmke Cat. I, they deliver comfort, grip, and ISO compliance.
👉 WeePro® Labo Sterile Overboots
Conformity & Validation
True cleanroom safety depends on measurable evidence — validated testing, strict compliance, and full traceability.
Standards & Certifications
Medicom’s PPE meets key benchmarks:
-
EN 1149-5: electrostatic discharge (ESD)
-
EN 13034 / EN ISO 13982-1 (Type 6 / 5): liquid splash and particle protection
-
EN 14126: infectious agents
-
ISO 16604: viral penetration
-
EN 14683 / EN 149: surgical and FFP mask performance
-
IEST-RP-CC003.4: Helmke Drum particulate release testing
Testing & Performance
Each product undergoes targeted testing:
-
Helmke Drum – particle release control, ISO correlation
-
Body Box Simulation – real-movement particulate emission in ISO 4
-
Bioburden Analysis – microbial load prior to sterilization
-
Filtration (BFE/PFE/VFE) – >99% efficiency, validated pre- and post-sterilization
-
Traceability – double or triple packaging, ETO sterilization per ISO 11135
FAQ – Cleanroom PPE
What are the essential PPE items for cleanroom entry?
Head covers, cleanroom masks, coveralls, gloves, overshoes — plus sleeves or ESD accessories as needed.
What’s the difference between sterile and non-sterile PPE?
Sterile items undergo validated ETO sterilization (ISO 11135) with double or triple packaging; non-sterile ones suit ISO 7–8 zones.
How can cross-contamination be avoided?
Follow the dressing order (head cover → mask → undergarment → coverall → gloves → overshoes) and use low-lint, Helmke-tested products.
Can sterile PPE be stored long-term?
Yes — provided storage follows expiry dates and environmental conditions (dry area, room temperature, away from UV).
Contact Medicom
Looking for a complete cleanroom solution? Our experts guide you from product selection to in-field validation. With over 50 years of expertise in single-use protection, Medicom offers certified, traceable PPE — designed, tested, and produced in France.
One goal: certified cleanroom PPE that protects people and processes — reliably, every day.
Not all PPE mentioned on this page is certified as PPE according to Regulation 2016/4255.