SKU shown: MEA210-1 (sterile, looped/headloop mask with blue clip connector).
Practical reality: people are the biggest variable in cleanrooms
In ISO-classified cleanrooms, the most common contamination driver is not the equipment — it is people:
skin flakes, fibers, droplets, and poor handling habits that bypass otherwise good facility design.
Masks reduce droplets and some particulates from breathing and speaking, but the real contamination-control impact comes from
consistent gowning (donning) technique, minimized touch points, and a complete garment system.
What this product is used for
- Personnel contamination control in Class 10 / ISO 4 cleanrooms and other sterile environments.
- Operations aligned to EU GMP Grade A/B expectations where personnel controls are treated as product-risk controls.
- Facilities that prefer a headloop + clip connector format for stable fit and reduced readjustment.
- Programs that require sterile masks with documented sterilization method, SAL, and defined packaging configuration.
Why customers consider MEA210-1 (manufacturer-positioned)
- Sterile and documented: gamma irradiated with SAL 10-6 and published storage/shelf-life guidance.
- Secure fastening: headloops and clip connector support quick, consistent placement behind the head.
- Cleaner construction details: ultrasonically sealed edges and an enclosed malleable noseband.
- Defined packaging: one per inner bag and a clear 600/case configuration supports receiving and kitting consistency.
Materials, composition, and build (manufacturer data)
Manufacturer-published construction includes: a polypropylene/polyethylene inner layer (hygroscopic), meltblown polyester filtration media,
a spunbonded polyester outer layer (hydrophobic), latex-free polyurethane loops, a blue plastic clip fastener, and a plastic-coated steel noseband.
Edges are ultrasonically sealed and the noseband is fully enclosed.
Specifications in context (receiving + SOP alignment)
| Attribute |
MEA210-1 (Published) |
| Re-order code |
MEA210-1 |
| Cleanroom / regulatory compatibility |
Class 10 / ISO Class 4 & EU GMP Grade A/B and other sterile cleanrooms |
| Packaging |
1 per sealed inner PE bag; 50 inner bags per sealed outer PE bag; 12 outer bags per lined carton (600 pieces) |
| Sterilization / SAL |
Gamma irradiation; minimum dose 25 kGy; SAL 10-6 |
| Shelf life / storage |
5 years; store dry/cool (<40°C) away from direct sunlight and fluorescent light |
| Dimensions (± 5 mm) |
210 mm (width) x 95 mm (height) |
| Performance (manufacturer) |
PFE 89.3% @ 0.1 micron; BFE 92.3% @ 0.3 micron; VFE 93.8% @ 3.0 micron; ΔP 3.8 mm H2O/cm2 |
| Standards listed by manufacturer |
ASTM F2101; ISO 2859; ISO 9001:2015 |
ISO-first: gowning (donning) as an operations control discipline
ISO cleanroom classification (ISO 14644-1) defines particle concentration limits by class, but day-to-day compliance depends on operations controls.
ISO 14644-5 (Operations) describes an operations control programme that includes personnel controls and cleanroom clothing behavior.
In practice: your mask is only as clean as the way it is staged, handled, and adjusted.
Donning guidance (looped mask with clip connector) — use with your facility SOP
- Sequence matters: in most cleanroom programs, don hair/hood controls first, then mask, then coverall/gown, then gloves (confirm your SOP).
- Keep the mask face “hands-off”: handle by the loops and edges; treat the outer face as a controlled surface.
- Clip it once, then stop touching it: pull loops behind the head and secure the clip; repeated re-adjustment is a primary contamination pathway.
- Form the noseband deliberately: set the noseband to reduce gaps; avoid repeated shaping after gloving.
- Replace when compromised: wet masks, torn masks, or masks frequently touched should be replaced per SOP.
EU Annex 1 overlay (European sterile manufacturing expectations)
EU GMP Annex 1 (sterile medicinal products) reinforces that contamination prevention is driven by a documented Contamination Control Strategy (CCS),
with personnel gowning and behavior treated as direct product-risk controls.
If Annex 1 applies to your operation, define sterile mask selection, transfer method (inner-bag handling), replacement frequency, and training/qualification in your CCS and SOPs.
Common failure modes (what breaks cleanroom intent)
- Touching the mask face during donning: handle by loops/edges only.
- Repeated adjustments after gloving: set clip and noseband once.
- Poor sequencing: hair/hood controls should prevent hair shedding into the mask zone.
- Mask reuse beyond SOP: single-use masks must be replaced when wet/compromised or per time-based rules.
SOSCleanroom continuity note (Ansell partnership)
Since 1981, SOSCleanroom (Specialty Optical Systems, Inc.) has supported contamination-controlled facilities with critical supplies, documentation-driven selection help,
and long-term manufacturer relationships — including Ansell. Our distribution performance has been recognized with multiple awards, including
11 Texas Instruments Supplier Excellence Awards.
SOSCleanroom note about SOP's
The Technical Vault is written to help customers make informed contamination-control decisions and improve day-to-day handling technique.
It is not your facility’s Standard Operating Procedure (SOP), batch record, or validation protocol.
Customers are responsible for establishing, training, and enforcing SOPs that fit their specific risks, products, equipment, cleanroom classification, and regulatory obligations.
Always confirm cleanliness suitability, sterility requirements, and acceptance criteria using your internal quality system and documented methods.
If you adapt any technique guidance from this entry, treat it as a starting template. Review and approve the final method, then qualify it for your specific workflow and risk profile.
Source basis (manufacturer-first)
- SOSCleanroom product page (MEA210-1): https://www.soscleanroom.com/product/brands/ansell-mea210-1-bioclean-sterile-looped-face-mask-class-10-iso-4/
- Ansell BioClean™ MEA210-1 Product Data Sheet (manufacturer PDF): https://www.soscleanroom.com/content/Ansell_PDF/bioclean-sterile-looped-face-mask-mea210-1_pds_us.pdf
- Ansell product page (MEA210-1): https://www.ansell.com/us/en/products/bioclean-sterile-looped-face-mask-mea210-1
- ISO 14644-1 (classification context): https://www.iso.org/standard/53394.html
- ISO 14644-5 (operations control programme context): https://www.iso.org/standard/88599.html
- EU GMP Annex 1 (sterile manufacturing context): https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf
SOSCleanroom is the source for this Technical Vault entry.
Briefed and approved by the SOSCleanroom (SOS) staff.
If you have any questions please email us at Sales@SOSsupply.com
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Last reviewed: Jan. 13, 2026
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