Biological Safety Cabinets are used in critical environments to protect product from contaminants and ensure the safety of the operator. They are designed to protect the both the product and the operator. There are several different configurations of Biological Safety cabinets, each designed for a specific application.
In accordance with regulatory standards, Biological Safety Cabinets must be certified at time of installation and at least annually thereafter.
| NOTE: If Biological Safety Cabinets are Primary Engineering Control devices as part of an USP 797 Compliant Pharmacy Cleanroom Environment, they shall be certified at least semi-annually. |
In addition, re-certification must be performed whenever HEPA filters are changed, repairs are made, or cabinet is relocated. More frequent certification intervals should be considered for particularly hazardous or critical applications or workloads.
Field certification of a cabinet is not intended to provide a complete verification that the cabinet conforms to all of the requirements of NSF / ANSI 49.
Biological Safety Cabinet Primary Tests (must pass to be certified)
- Document customer, location, and area device is located
- Device ID#, manufacturer, model number, and serial number of device tested
- Downflow velocity profile test (Uniform OR Non-uniform Downflow)
- Inflow face velocity test
- Airflow smoke pattern test
- Downflow test (pass or fail)
- Viewscreen retention test (pass or fail)
- Work opening edge retention test (pass or fail)
- Sash/Window seal test (pass or fail)
- HEPA filter leak/challenge test
- Site installation assessment tests
- Cabinet integrity test (for positive pressure plenum cabinets only, Type A1)
Biological Safety Cabinet Secondary Tests (recommended)
- Light intensity
- Noise level
Biological Safety Cabinet Additional Tests (if requested by customer)
- Vibration
- Electrical leakage, GFI resistance, and polarity
- Decontamination
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