SKU shown: BDBS (sterile pouch/duckbill face mask, 200/case).
Why facemasks matter in cleanrooms (and why “fit + behavior” matter even more)
Personnel are one of the largest sources of cleanroom contamination. Even in well-designed airflow, poor gowning technique and frequent face-touching can drive particle and droplet release.
The BioClean™ BDBS is positioned as a sterile, cleanroom-compatible facemask to help reduce that risk in Class 10 / ISO Class 4 environments and EU GMP Grade A/B operations.
The mask’s pouch/duckbill geometry creates a large breathing chamber, and the noseband helps improve fit to reduce gaps.
What this product is used for
- Reducing droplet/particle shedding from the nose/mouth region during aseptic and critical cleanroom tasks.
- Supporting sterile gowning sets where mask sterility, packaging integrity, and shelf-life control are required.
- Maintaining standardized PPE selection in ISO Class 4 and EU Grade A/B gowning programs.
- Minimizing contamination risk during entry/exit and movement in controlled environments (when paired with qualified gowning behaviors).
Why customers consider this product
- Sterile, defined processing: gamma irradiated (minimum 25 kGy) with SAL 10-6 and manufacturer-defined shelf life/storage.
- High filtration performance (published): PFE 97.1% @ 0.1 µm; BFE 94% @ 0.3 µm; VFE 96.4% @ 3.0 µm.
- Comfort supports compliance: large breathing chamber and headloop design can reduce readjustments.
- Cleanroom-focused construction: cleanroom-compatible materials and ultrasonically sealed edges to reduce contamination risk during entry.
Materials, composition, and build
Manufacturer-listed material is Polyester / Polyurethane. The inner facing layer is a
non-woven spunbonded polyester (hygroscopic), and the outer layer is a
non-woven spunbonded polyester (hydrophobic).
The mask uses tubular knitted polyurethane Spandex yarn headloops and a
plastic coated steel noseband. Overall dimensions are 301 mm (W) x 100 mm (H) (± 5 mm).
Specifications in context
The table below consolidates the attributes most relevant to cleanroom receiving, gowning qualification, and day-to-day contamination control.
All numeric values are from the manufacturer’s technical data sheet.
| Attribute |
BDBS |
| Reorder / part number | BDBS |
| Cleanroom positioning | Class 10 / ISO Class 4 & EU GMP Grade A/B |
| Sterility | Sterile |
| Sterilization / minimum dose | Gamma irradiation / 25 kGy minimum |
| SAL | 10-6 |
| Material | Polyester / Polyurethane |
| Layers (inner / outer) | Spunbonded polyester (hygroscopic) / spunbonded polyester (hydrophobic) |
| Fastening | Headloop (PU Spandex yarn headloops) |
| Noseband | Plastic coated steel |
| Dimensions | 301 mm (W) x 100 mm (H) (± 5 mm) |
| PFE | 97.1% @ 0.1 micron |
| BFE | 94% @ 0.3 micron |
| VFE | 96.4% @ 3.0 micron |
| Differential pressure | 3.1 mm H2O/cm2 |
| Packaging | 1/inner PE bag; 20 inners/outer bag; 10 outers/lined carton (200 pieces) |
| Shelf life | 5 years from date of manufacture |
| Storage | Dry/cool (<40°C), away from direct sunlight and fluorescent light |
| Country of origin | China |
Performance and cleanliness considerations
For cleanroom facemasks, “performance” is typically about reducing droplet/particle shedding while maintaining wearer comfort so the mask stays on and stays positioned.
BDBS publishes filtration performance (PFE/BFE/VFE) and differential pressure to support selection and qualification decisions.
Important operational note: A mask is only as effective as the gowning behavior around it. Touching the mask front, wearing below the nose, or leaving gaps around the noseband
can defeat the purpose in high-grade areas.
Gowning (donning) education: ISO first, then EU Annex 1 emphasis
ISO operations mindset (what to train and enforce)
- Build an Operations Control Program (OCP): include a gowning program, entry/exit controls, cleaning/monitoring, and personnel management.
- Qualify the behavior, not just the garment: train donning sequence, movement discipline, and “no-touch” habits for critical surfaces.
- Standardize across shifts: the same gowning steps, the same checkpoints, and the same rejection rules (drop/tear/damaged pouch).
- Document what “good” looks like: visual checks plus periodic reassessment per your quality system.
Practical donning sequence template (adapt to your SOP)
- 1) Hand hygiene: wash/sanitize per SOP; dry fully.
- 2) Open sterile pouch correctly: avoid tearing that can generate particles; do not let the mask contact non-controlled surfaces.
- 3) Handle by headloops: keep fingers off the mask front; position over nose and mouth.
- 4) Form the noseband: pinch/mold to reduce gaps; re-check after hood/eye covering placement.
- 5) Integrate with hood/eye coverings: ensure mask stays sealed and remains correctly positioned.
- 6) Final check: if you touch the front surface, the mask drops, or the pouch is compromised, discard and replace.
EU GMP Annex 1 (sterile pharma) emphasis: Annex 1 highlights that for Grade B (supporting Grade A), operators should use
sterile facemasks and sterile eye coverings to cover/enclose facial skin and reduce droplet/particle shedding, along with qualified gowning procedures.
Implement these expectations through your facility CCS and SOPs.
Common failure modes (what to coach out of the process)
- Touching the mask front: reintroduces contamination and drives face-touching habits.
- Wearing below the nose: defeats the purpose for droplet control.
- Loose noseband / visible gaps: increases leakage and encourages readjusting.
- Compromised pouch integrity: treat as sterile breach; discard.
- Mask contacts the floor or non-controlled surfaces: discard and replace immediately.
Closest alternatives (how to compare correctly)
Compare sterile documentation depth, packaging configuration, and published filtration/differential pressure metrics—not just “sterile yes/no.”
For this family, nearest alternatives are other BioClean™ sterile mask formats and neck-coverage variants.
- BioClean™ BDBS-G (neck guard): added neck coverage where your risk assessment requires it.
- BioClean™ MTA210-1 (tie-on): tension adjustment via ties; confirm compatibility with hood/eye covering configuration.
- BioClean™ MEA210-1 (looped): alternate loop geometry for fit preference; confirm gowning qualification outcomes.
Critical environment fit for this product
BDBS is a strong fit when your gowning program requires a sterile facemask component aligned to ISO Class 4 / EU Grade A/B contamination-control expectations,
with published filtration and pressure-drop characteristics and defined packaging/shelf-life controls.
As always, qualify the full gowning set (hood/eye coverings/coverall/gloves) and the operator behavior as one system.
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 suitability, sterility requirements, acceptance criteria, and gowning qualification methods using your internal quality system and documented procedures.
If you adapt any technique guidance from this entry, treat it as a starting template. Your team should review and approve the final method, then qualify it for your specific risks and workflows.
Use these best-practice suggestions to strengthen your SOPs—not to replace them.
Source basis
- SOSCleanroom product page (BDBS): https://www.soscleanroom.com/product/brands/ansell-bdbs-bioclean-sterile-db-pouch-style-face-mask-class-10-iso-4/
- Manufacturer Product Data Sheet (BDBS) hosted by SOSCleanroom: https://www.soscleanroom.com/content/Ansell_PDF/bioclean-sterile-db-pouch-style-face-mask-bdbs_pds_us.pdf
- ISO 14644-1 (classification context): https://www.iso.org/standard/53394.html
- ISO 14644-5 (operations / gowning program context): https://www.iso.org/standard/88599.html
- EU GMP Annex 1 (personnel gowning expectations 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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