SKU shown: 62470 (sterile pleat-style mask with knitted earloops).
Why face masks matter in cleanrooms
In most cleanrooms, people are the dominant contamination source. Talking, breathing, coughing, facial movement, and skin/hair shedding can release particles and microorganisms that end up on critical surfaces or product.
A cleanroom mask is not a “nice-to-have” accessory — it is a primary barrier that reduces emission from the mouth and nose and helps stabilize a controlled environment when used with correct gowning technique.
The Kimtech PURE* M3 sterile mask program (62470) is designed to support this goal through low-lint materials, sterile processing, and manufacturer-published post-sterilization performance data.
Standards context (ISO first; Annex 1 second)
ISO 14644-1 defines cleanroom classification by airborne particle concentration (the ISO Class number is the language most industries use to define air cleanliness).
ISO 14644-5 addresses cleanroom operations and calls for an Operations Control Program that includes personnel controls and a gowning program as part of maintaining specified cleanliness levels.
For sterile medicinal product manufacturing in Europe, EU GMP Annex 1 adds expectations for contamination control strategy, risk management discipline, and gowning practices appropriate to Grades A/B/C/D.
Practically: ISO establishes the cleanroom classification framework and operational program concept; Annex 1 increases rigor for sterile pharma and aseptic processing environments.
What this mask is (manufacturer-defined)
Kimtech PURE* M3 (62470) is a certified sterile, pleat-style face mask with knitted earloops. The manufacturer describes a low-lint polyethylene outer layer, a soft inner-facing fabric, meltblown filtration media, ultrasonic construction, and a fully enclosed soft malleable nosepiece.
The product is gamma irradiated and validated to a Sterility Assurance Level (SAL) of 10-6. It is supplied as 20 masks/bag, 10 bags/case (200 masks/case).
Specifications in context (receiving + qualification)
| Attribute |
Kimtech PURE* M3 — 62470 |
| SKU / code |
62470 |
| Style |
Pleat-style; knitted earloops; enclosed malleable nosepiece |
| Size / width |
7" (18 cm), one-size format (manufacturer program) |
| Sterility / method |
Gamma irradiated; SAL 10-6 |
| Packaging |
20 masks/bag; 10 bags/case = 200 masks/case |
| Outer layer |
Low-lint polyethylene outer layer (apertured film / film outer) |
| Filter media |
Meltblown polyester (manufacturer sheet) |
| Published post-sterilization filtration |
PFE 89.3% @ 0.1 micron; BFE 94.1% @ 3.0 micron (manufacturer sheet) |
| Published breathability |
Differential pressure 2.16 mm H2O @ 8 LPM (manufacturer sheet) |
| Recommended cleanroom level |
ISO Class 3 and higher (manufacturer guidance) |
Proper gowning (donning) education: mask technique that minimizes contamination
ISO operations concepts (ISO 14644-5) treat gowning as a controlled process: the goal is to prevent contamination transfer from the operator to the environment and to prevent gown surfaces from contacting non-controlled surfaces.
The mask is a high-impact component because it sits at the highest emission zone (mouth/nose).
Donning steps (general template — always follow your facility SOP)
- Pre-gowning readiness: remove jewelry per SOP, secure hair, and perform hand hygiene before touching any cleanroom PPE.
- Open clean packaging correctly: avoid snapping bags open; keep the mask from contacting counters, clothing, or the floor.
- Handle only by earloops: treat the mask body as contamination-sensitive. Avoid touching the filtration area.
- Fit discipline: cover nose and chin fully; mold the enclosed nosepiece to reduce gaps that can increase emission and fogging.
- Sequence control: many gowning rooms place the mask before hood/coverall so the hood overlap can seal around it — but sequence is SOP-dependent.
- Do not “hang down” or re-stage: if the mask is removed or becomes compromised, discard and replace per SOP.
- Change triggers: replace if wet, damaged, visibly soiled, or after leaving controlled space (facility-defined).
Annex 1 overlay (European sterile manufacturing): gowning expectations are typically stricter in Grades A/B (aseptic processing support), including stronger emphasis on operator practices, garment system integrity, and contamination control strategy.
If your program aligns to Annex 1, treat mask selection and change frequency as a documented risk control, not an informal habit.
Common failure modes (what causes avoidable contamination)
- Touching the mask body during donning or adjustment: handle by earloops; adjust fit using the nosepiece ends rather than pressing the filtration area.
- Loose fit / gaps: mold the nosepiece; ensure full nose-to-chin coverage to reduce emission.
- Mask worn below the nose: defeats the primary contamination-control purpose.
- Re-use after exit: re-entry with the same mask is a common contamination transfer mechanism unless explicitly permitted by SOP.
- Wet mask continued in use: moisture changes filtration and comfort; replace per SOP and risk profile.
SOSCleanroom perspective: continuity, documentation, and supply
Since 1981, SOSCleanroom (Specialty Optical Systems, Inc.) has supported cleanrooms with critical supplies.
Our long-term servicing of contamination-control programs includes deep experience with leading manufacturers (including Ansell programs) and documented performance expectations.
SOSCleanroom has earned multiple distribution recognitions, including 11 Texas Instruments Supplier Excellence Awards, reflecting long-term performance in supply reliability and customer support.
