In cleanrooms, the operator is one of the largest variable contamination sources. Facial skin, breath, and inadvertent mask-touch behaviors can introduce particles and droplets into the work zone. The BioClean™ BDBS-G is positioned by the manufacturer as a sterile face mask with an integrated, extra-long neck guard to increase coverage at the collar interface and reduce cross-contamination risk. For performance and acceptance criteria, this entry references the manufacturer Product Data Sheet first.

• ISO Class 4 / Class 10 cleanroom workflows requiring sterile facial/neck coverage as part of gowning.
• EU GMP Grade A/B aseptic operations where gowning qualification and face/neck controls are emphasized by program expectations.
• Life sciences and critical manufacturing processes where mask integrity and fit help reduce droplet and particle shedding risk.
• Operations that benefit from standardized, sterile packaged PPE with defined storage and shelf-life guidance.

• Coverage at a common gap: the integrated neck guard helps reduce exposed-skin risk at the hood/neckline interface.
• Sterile format: gamma irradiated with published SAL 10^-6, supporting sterile area entry requirements where mandated.
• Published filtration performance: PFE/BFE/VFE values and differential pressure published on the manufacturer Product Data Sheet.
• Comfort supports compliance: a larger breathing chamber can reduce frequent adjustments that create contamination risk.
• Audit-friendly standardization: defined packaging configuration and storage/shelf-life guidance support consistent receiving and use.

Per the manufacturer Product Data Sheet, BDBS-G is built from polyester / polyurethane with a layered non-woven architecture: spunbond polyester inner (hygroscopic), meltblown polyester filtration layer, spunbond polyester outer (hydrophobic), and a non-woven spunbonded polyester neck guard. The mask includes polyurethane Spandex headloops and a plastic-coated steel noseband.

This construction is intended to support filtration performance while maintaining usability (fit, breathing comfort) that helps reduce operator adjustment behaviors.

The table below consolidates attributes used for cleanroom receiving, gowning program alignment, and day-to-day contamination control. Values are taken from the manufacturer Product Data Sheet unless otherwise noted.

Attribute	BDBS-G
Part number / reorder no.	BDBS-G
Cleanroom class (manufacturer statement)	Class 10 / ISO Class 4 & EU GMP Grade A/B
Material	Polyester / Polyurethane
Sterilization / SAL	Gamma irradiation; SAL 10-6; minimum dose 25 kGy
Dimensions (± 5 mm)	Face mask: 301 mm (W) x 100 mm (H); Neck guard: 245 mm (W) x 210 mm (H)
Filtration performance	PFE 97.1% @ 0.1 µm; BFE 94% @ 0.3 µm; VFE 96.4% @ 3.0 µm
Differential pressure	3.1 mm H2O/cm²
Fastening / noseband	Headloop; plastic-coated steel noseband
Packaging overview	1 per sealed inner PE bag; 20 inner bags per sealed outer PE bag; 10 outer bags per lined carton (200 pieces)
Shelf life / storage	5 years; store dry/cool (<40°C) away from sunlight and fluorescent light
Country of origin	China

In controlled environments, a mask must do two things well: (1) reduce droplets/particles from the wearer, and (2) stay in place without constant adjustment. The manufacturer publishes filtration efficiency and differential pressure values that can be used for selection comparisons. For cleanroom program fit, the integrated neck guard is the differentiator: it targets the collar interface where exposed skin and gown seams can become contamination weak points.

BDBS-G packaging is structured for controlled entry and staged gowning: one mask per sealed inner PE bag, bundled into outer bags, and then into a lined carton (200 pieces total). Sterility is by gamma irradiation with published SAL 10^-6 and a stated minimum dose. Treat packaging integrity checks and shelf-life verification as receiving requirements within your quality system.

• Handle by loops: avoid touching the front/filter surface.
• Set the noseband once: mold gently to reduce gaps and fogging.
• Integrate the neck guard: tuck under the hood/coverall neckline so skin is not exposed at the seam.
• Replace if compromised: wet/damaged masks, or masks repeatedly touched/adjusted, should be replaced per SOP.

• Front-of-mask touching: train loop-only handling; improve comfort/fit to reduce adjustments.
• Neckline exposure: ensure the neck guard is properly tucked and that hood/suit interfaces overlap consistently.
• Poor nose seal: re-train on noseband setting and eye protection pairing.
• Using expired or compromised packaging: treat packaging integrity and shelf-life as receiving controls.

Comparable alternatives are other sterile cleanroom face masks specified for ISO Class 4 / EU Grade A/B use. When comparing, prioritize: sterilization method/SAL, packaging configuration, comfort/fit behavior, and published filtration/differential pressure values — not just price.

BDBS-G is a strong fit when your contamination control strategy requires sterile, high-coverage facial PPE and your gowning system targets the hood/neck seam as a risk point. It is especially relevant for Grade A/B-style aseptic behaviors and ISO Class 4 operations where facial and neckline shedding must be tightly controlled.