Biosafety Cabinet Certification, Chemical Fume Hood, Laminar Flow Hood & Clean Room Certification Services

Femto Scientific certifies all Class I, Class II (Type A1, A2, B1, and B2), and Class III biosafety cabinets per NSF/ANSI 49. We also certify chemical fume hoods (including ductless and ducted), laminar flow hoods (horizontal and vertical), clean benches, and biological safety cabinet/isolator combinations. For cleanroom environments, we perform ISO 14644 classification testing (ISO Class 5 through ISO Class 9), USP <797> and USP <800> compliance testing for pharmaceutical compounding facilities, and cGMP cleanroom qualification for pharmaceutical manufacturing. Manufacturers we certify include Thermo Fisher, Labconco, Esco, Baker Company, NuAire, Germfree, AirClean Systems, Erlab, Yamato, and many more. Contact us if your manufacturer is not listed.

A complete NSF/ANSI 49 biosafety cabinet certification includes the following tests: (1) Inflow velocity testing — measuring air velocity entering the cabinet at the work opening to verify personnel protection; (2) Downflow velocity testing — measuring airflow across the work surface at a defined grid per NSF/ANSI 49 and manufacturer specifications; (3) HEPA filter integrity testing (PAO/DOP scan) — scanning the HEPA supply and exhaust filters for leaks and defects; (4) Cabinet containment testing — verifying that the cabinet prevents outward leakage of aerosolized agents; (5) Smoke pattern testing — airflow visualization confirming unidirectional flow and containment at the work opening; (6) Alarm and safety system verification; and (7) Electrical safety check including lighting, UV lamp output, and blower motor performance.

The standard industry requirement, per CDC/NIH biosafety guidelines, NSF/ANSI 49, and most institutional biosafety programs, is that biosafety cabinets be certified annually under normal operating conditions. Additional certification is required after any event that may affect cabinet performance: relocation or movement of the cabinet (even within the same room); replacement of HEPA filters or major components; repair to the cabinet frame, blower, or internal structure; after work with highly hazardous agents requiring decontamination; or after extended periods of non-use. Compounding pharmacies operating under USP <797> must certify primary engineering controls every 6 months. Contact Femto Scientific to establish a certification schedule appropriate for your specific compliance program.

Yes. Femto Scientific provides cleanroom certification services that satisfy the requirements of USP Chapter <797> (sterile compounding) and USP Chapter <800> (hazardous drug compounding). For USP <797> compliance, we certify the ISO Class 5 primary engineering controls (laminar flow hoods, biological safety cabinets), the ISO Class 7 buffer room, and the ISO Class 8 ante-room every 6 months as required. Testing includes ISO 14644-1 particle count testing, air change rate verification, room pressurization/differential pressure measurement, HEPA filter integrity testing, and temperature and humidity verification. For USP <800>, we additionally certify containment primary engineering controls (C-PECs) and containment secondary engineering controls (C-SECs) per the USP <800> certification requirements. All results are documented in a certification report formatted for pharmacy board inspection and USP compliance audits.

Both are Class II biosafety cabinets providing personnel, product, and environmental protection, but they differ in airflow configuration and exhaust handling. A Class II Type A2 cabinet recirculates approximately 70% of cabinet air through a HEPA supply filter back into the work zone, and exhausts the remaining 30% through a HEPA filter into the room or building exhaust. Type A2 cabinets can be used for work involving biological agents and small quantities of non-volatile toxic chemicals, but are not suitable for volatile solvents or significant chemical vapors. A Class II Type B2 cabinet exhausts 100% of cabinet air through a HEPA filter to the building exhaust system (hard-ducted) — no air is recirculated into the work zone. Type B2 cabinets are required for work involving chemical carcinogens, radionuclides, or significant quantities of volatile toxic chemicals. Type B2 cabinets require a dedicated exhaust blower and duct connection and must be certified with the exhaust system connected and operating within specifications.