Laminar Flow Benches are used in critical environments to protect product from contaminants. They are designed to protect the product, not for operator protection.
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.
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.
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:
- All performance testing datasheets contain reference number, testing standard used, date of test, and person who performed the testing.
- A comprehensive computer generated report will be furnished with all testing results and indicating any required recommendations.
- Prepare and submit a budgetary proposal for any items deemed defective and/or requiring repair.
- IEST, Institute of Environmental Science and Technology
- ISO 14644, International Organization for Standardization
- CETA, Controlled Environmental Testing Association
- ACGIH, American Conference of Governmental Industrial Hygienists
- Manufacturer Specifications