Laminar Flow Benches are used in critical environments to protect product from contaminants. They are designed to protect the product, not for operator protection.
|NOTE: If Laminar Flow Benches are Primary Engineering Control devices as part of an USP 797 Compliant Pharmacy Cleanroom Environment, they shall be certified at least semi-annually.|
In accordance with regulatory standards, Laminar Flow Benches must be certified at time of installation and at least annually thereafter. In addition, re-certification must be performed whenever HEPA filters are changed, repairs are made, or bench is relocated.
More frequent re-certification intervals should be considered for particularly hazardous or critical applications or workloads.
Laminar Flow Bench 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
- Device type and direction
- Pre-filter information, if feasible
- Air velocity (face velocity) test
- HEPA filter leak/challenge test
- Non-viable airborne particle count
Detailed Summary Report: