§ 627.50 - Class I biological safety cabinet.

(a) Description. The Class I biological safety cabinet (figure H-I in appendix F to this part) is a ventilated cabinet for personnel protection only. The cabinet provides an uncirculated inward flow of air away from the operator. The exhaust is passed through a HEPA filter. It may be discharged into the laboratory or vented out of the laboratory and dispersed away from occupied spaces or air intakes. When the exhaust is recirculated in a BL-2 or BL-3 facility, the cabinet must be tested and certified annually. In a BL-4 facility, if the exhaust is recirculated, the cabinet must be tested and certified semiannually.

(b) Uses. These cabinets are used if personnel protection against the microorganisms is required; for modest quantities of volatile, toxic, or radioactive chemicals (in concentrations and quantities associated with biological systems) if vented to the outside; and when sterility is not required. They are commonly used for housing tabletop centrifuges, in the necropsy of small animals, and for changing animal bedding.

(c) Prohibitions. This class of cabinet is not to be used when sterility must be maintained. In addition, volatile, toxic, or radioactive materials can not be used in this class of cabinet when the exhaust air is not exhausted to the exterior.

(d) Certifications and requirements. (1) The inward air velocity on these cabinets will be an average of 100 plus or minus 20 linear feet per minute (lfpm). Each cabinet must be certified before use and semiannually thereafter by a face velocity test. Additionally, smoke tests will be performed annually to verify containment.

(2) The exhaust system will have a HEPA filter, which will be tested initially upon installation, after repair or replacement, and every 2 years thereafter (except when required more often). Filters will be certified to be 99.97 percent effective in capturing particulate matter by a leakage test using mineral oil or other appropriate aerosol dispersed as 0.3 micron droplets.