Operations takeaway: Eye protection can be a contamination-control interface, not just “safety PPE.” Stable fit + clear visibility + controlled reprocessing reduce the need for mid-process adjustments that generate particles and increase touch risk. In hazardous drug programs (USP <800>), goggles are specifically relevant when splash/spill risk exists.

Control point: Eye PPE failures are often “process failures” (fit issues, fogging, strap drift, untracked autoclave cycles, or incompatible cleaning chemistry) that drive operators to adjust goggles during work—creating predictable contamination events.

• Product: Ansell BioClean™ Clearview™ Autoclavable Goggles (BCAG)
• SKU: BCAG
• Cleanroom positioning: Class 10 / ISO 4 (manufacturer positioning; confirm method fit per SOP)
• Sterility: Supplied non-sterile (intended to be autoclaved prior to use per program requirements)
• Reprocessing method: Autoclave at 121°C / 250°F for 30 minutes (manufacturer guidance)
• Optical / standards: Optical Class 1; EN 166:2001; Category II; CE; UKCA (manufacturer documentation)
• Lens: Toughened polycarbonate, optically correct; anti-fog performance stated up to 25 autoclave cycles for the lens (manufacturer statement)
• Autoclave durability: Tested to withstand up to 40 autoclave cycles for the housing at 121°C/30 minutes (manufacturer statement)
• Ventilation: Upper vents with indirect lower ventilation system (design intent: reduce contamination ingress)
• OTG: Designed to be worn over eyeglasses (over-glasses compatible)
• Materials: Thermoplastic rubber, polycarbonate, polypropylene, silicone
• Dimensions / weight: Lens thickness 3.1 mm; bridge width 70 mm; bridge height 26 mm; overall width 190 mm; overall height 85 mm; weight ~103 g (manufacturer basis)
• Packaging (case): 1 per sealed PE bag (remove prior to autoclaving); 12 bags per inner box; 5 boxes per carton (60/case)

Documentation rule: For controlled/validated programs, base acceptance criteria on current manufacturer documentation and your internal release criteria (not web summaries).

• Controlled-environment gowning programs where stable OTG eye protection reduces face/eye-area adjustments and supports repeatable PPE execution.
• Reusable PPE programs where the SOP defines autoclave parameters, cycle tracking, inspection criteria, and controlled post-autoclave handling/storage.
• Tasks requiring clear vision for extended durations where optical class and anti-fog performance help minimize rework and operator touch behaviors.
• Work areas where indirect ventilation designs are preferred to reduce contamination ingress while maintaining wearer comfort.
• USP <800> / hazardous drug programs: When the task presents a credible splash/spill risk during handling, compounding, administration support, or spill response—goggles are used as splash-risk PPE (facility risk assessment + SOP govern the exact configuration).

USP <800> note (why goggles matter): In USP <800> practice, goggles are commonly specified when there is risk of hazardous drug splashes/spills; safety glasses are generally not considered an equivalent substitute for splash-risk control. Align goggle selection with your hazard assessment, workflow, and the rest of the PPE system (gown, gloves, respirator/face protection as applicable).

1. Place goggles intentionally in the gowning sequence: Many SOPs don hood/mask first, then goggles, then final glove-up to avoid touching the face after gloving.
2. One fit, then no-touch: Set strap tension once. Repeated micro-adjustments are a predictable contamination and deviation trigger.
3. Control fogging at the root cause: Validate anti-fog performance under your conditions; replace/retire when fogging exceeds baseline.
4. Reprocessing discipline (reusable programs): Track autoclave cycles, define max cycle count, and document inspection/release criteria.
5. Chemistry compatibility: Follow manufacturer guidance to protect lens coatings; validate any alternative cleaning/disinfection chemistry under your QMS.
6. Controlled storage after reprocessing: Store reprocessed goggles in defined clean packaging/location to prevent re-contamination prior to issuance.

Manufacturer lens-care warning: Manufacturer guidance for BCAG warns to avoid alcohol, thinner, peracetic acid, bleaching agents, or hydrogen peroxide on the lens, as these can damage the anti-fog coating. Autoclaving is the recommended disinfection method; remove the sealed PE bag prior to autoclaving.

• If sterility is required at point of use: BCAG is supplied non-sterile; use only if your SOP supports autoclave reprocessing and controlled handling/release.
• If reprocessing cannot be controlled: Avoid reusable goggles where cycle tracking, inspection, and controlled storage cannot be enforced.
• If lens chemistry conflicts with site practice: Do not use if your current cleaning/disinfection chemistry is incompatible with anti-fog coatings and cannot be validated.
• If splash risk is present and seal/fit is inadequate: For hazardous drug splash scenarios, confirm fit and coverage; do not substitute safety glasses for splash-risk eye PPE when goggles are required by policy/risk assessment.

• Ansell BEXS BioClean™ Excell Sterile Nitrile Gloves (Class 10 / ISO 4) — sterile nitrile option commonly paired in ISO 4 gowning programs where low particle contribution and disciplined glove-change rules are enforced
• Ansell BASL BioClean™ Advance Sterile Latex Gloves (Class 10 / ISO 4) — sterile latex option used in controlled environments where tactility is prioritized (confirm latex policy/allergen controls per site)

Glove discipline: Change gloves when contaminated, torn, or after contacting non-controlled surfaces. Treat glove technique as part of the PPE system (especially during donning/doffing).

For ports, crevices, and recessed features where a wiper cannot maintain contact control, use a sterile cleanroom swab to keep the cleaning method consistent and to reduce accidental contact with critical surfaces.

• SOSCleanroom product page (BCAG): Click Here
• Manufacturer Product Data Sheet (BCAG): Click Here
• EU Declaration of Conformity (BCAG): Click Here
• UK Declaration of Conformity (BCAG): Click Here
• BioClean goggle marking explanation sheet: Click Here
• ISO 14644-5:2025 operations standard overview (ISO listing): Click Here
• ISO 14644-1 cleanroom classification context (ISO listing): Click Here
• EU GMP Annex 1 (sterile manufacturing gowning expectations): Click Here
• USP <800> PPE (eye protection / splash-risk context): Click Here
• OSHA hazardous drugs PPE (goggles as appropriate PPE under hazard assessment): Click Here