Laminar Flow Bench Testing & Certification

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:

Standards Utilized:

  • 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
  • ISO14644, International Organization for Standardization
    • CETA, Controlled Environmental Testing Association
    • ACGIH, American Conference of Governmental Industrial Hygienists and manufacturer specifications

Comments are closed.