Operations takeaway: “Reusable” does not automatically mean “controlled.” A reusable goggle program works only when your facility controls status (used vs. autoclaved vs. released), cycle limits, inspection triggers, and lens-coating compatibility so operators do not improvise cleaning at the gowning boundary.

Control point: Indirect ventilation is typically preferred when splash/droplet control and contamination-entry risk are concerns. Define in the SOP how goggles are donned, cleaned, stored, and replaced so the face seal and inner lens remain protected.

• Product: Ansell BioClean™ Clearview™ Autoclavable Goggles
• Reorder number: BCAH
• Cleanroom class: Class 10 / ISO 4 (manufacturer stated)
• Sterility: Supplied non-sterile (reprocessing required where applicable)
• Materials (manufacturer stated): Polycarbonate; silicone rubber; polypropylene
• Lens: Optically correct polycarbonate anti-fog lens; designed for use over eyeglasses (OTG)
• Ventilation: Indirect ventilation system (manufacturer stated)
• Reprocessing method (manufacturer stated): Autoclave at 121°C / 250°F for 30 minutes
• Cycle guidance (manufacturer stated): Tested to withstand 40 autoclave cycles (30 minutes at 121°C / 250°F); tolerance of up to 1 gamma irradiation cycle
• Packaging (manufacturer stated): One goggle per sealed PE bag (remove prior to autoclaving); 12 bags per inner box; five boxes per carton (60 pieces)

Documentation rule: For controlled/validated programs, base acceptance criteria and cycle limits on current manufacturer documentation and your internal quality system. Do not “infer” disinfectant compatibility—verify it.

• ISO 4 (Class 10) gowning programs that want a reusable, autoclavable eye-protection platform with defined cycle behavior.
• Operators who wear prescription eyewear and need a goggle solution that can be worn over glasses (OTG).
• Cleanroom cleaning and preparation activities where indirect ventilation and controlled handling/storage reduce contamination transfer risk.
• Facilities with established autoclave capacity and segregation controls (used/autoclaved/released) to support repeatable reprocessing.
• Programs that require visibility and reduced fogging to minimize lens/strap/face touches during work.

USP <800> note (task-based): In hazardous drug workflows, eye protection is commonly required when there is credible risk of splash, spray, or spill exposure. In higher splash-risk tasks, a face shield may be layered over goggles so the eyes remain protected by a sealed interface while the full face is shielded (implement per SOP and risk assessment).

1. Stage correct status only: bring only “autoclaved/released” goggles into the gowning boundary (per your SOP and release rules).
2. Don without contaminating critical surfaces: handle by strap and frame edges; avoid touching the inner lens surface.
3. Set fit before sterile gloves (if applicable): tension and seal should be finalized before final glove donning to avoid rework.
4. Define reprocessing limits: track autoclave cycles and replace when seal, strap, or lens performance degrades.
5. Control cleaning chemistry: follow manufacturer lens-coating compatibility guidance; qualify alternates rather than improvising at the gowning boundary.
6. Segregate used vs. ready: prevent cross-status mix-ups during shift changes using designated containers, labels, and custody rules.

Method standardization tip: If lens haze or fogging returns, treat anti-fog performance as a consumable attribute: inspect, trend, and replace based on defined triggers.

• Do not treat non-sterile as sterile: if sterility is required for the workflow, do not use unless your reprocessing/release pathway supports it.
• Do not improvise disinfectants: uncontrolled chemistry can damage lens coatings and compromise visibility and anti-fog performance.
• Do not ignore segregation controls: mixing “used” and “ready” goggles defeats gowning control and creates audit risk.
• Do not “work through” degraded performance: scratched/hazy lenses, seal damage, and strap failure are operational failures—replace.

• Ansell BASL BioClean™ Advance Sterile Latex Gloves (Class 10 / ISO 4) — sterile ISO 4-positioned glove option for critical gowning and handling (verify suitability per site SOP and latex sensitivity policy)
• Ansell BEXS BioClean™ Excell Sterile Nitrile Gloves (Class 10 / ISO 4) — sterile ISO 4-positioned nitrile glove option for controlled handling and broad compatibility (verify suitability per site SOP)

Glove discipline: Don goggles with clean gloves; avoid touching inner lens surfaces. Change gloves when contaminated, torn, or after contacting non-controlled surfaces.

For gasket channels, vent interfaces, and small edges where a wipe cannot maintain contact control, use a sterile cleanroom swab to keep cleaning localized and to avoid dragging residues across the lens. Always validate compatibility with lens coatings and approved chemistry in your SOP.

• SOSCleanroom product page (BCAH): Click Here
• Manufacturer Product Data Sheet (BCAH): Click Here
• EU Declaration of Conformity (BCAH): Click Here
• UK Declaration of Conformity (BCAH): Click Here
• BioClean™ goggle marking explanation sheet: Click Here
• ISO cleanroom classification context (ISO 14644-1): Click Here
• ISO cleanroom operations context (ISO 14644-5): Click Here
• EU GMP Annex 1 (sterile manufacturing; gowning included): Click Here