CLEANROOM TESTING AND CERTIFICATION

Air Systems Technologies, Inc. _www.AirS

High Technological Cleaning and Environmental Engineering Services

Air Systems Technologies will insure not only compliance with regulatory agencies, but product and process protection as well.  ​

HEPA Filtered Devices

Class I, II & III Biological Safety Cabinets

Laminar Flow Clean Benches

Laminar Flow Clean Rooms

Depyrogenation Ovens

Rx Isolators

Gloveboxes

Ventilated Enclosures

HEPA Filter Banks

Chemical Fume Hoods/ Exhaust Hoods

ASHRAE 110 Tracer Gas Testing

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Field Certification Is Essential

Biosafety cabinet field tests should be performed by the certifier upon installation and relocation of cabinets, after major maintenance or changing of HEPA filters is conducted, and at regular intervals thereafter. NSF 49 recommends no more than 12 months between certification, though many organizations recertify more frequently. For example, pharmacies certify their biosafety cabinets every 6 months as required by USP Chapter <797> on sterile compounding.

In order to verify proper operation of a biological safety cabinet, the following tests are performed. These tests are related to the containment and product protection provided by the cabinet, and results must correlate to the value obtained by NSF for type testing of that particular make, model, and size of cabinet.

All testing is performed in accordance with Air Systems Technologies Standard Operating Procedures and each client receives a thorough report that detail the tet procedures, results and conclusions.  A proactive approach provides early warnings of potential problems that can cause costly down times or process contamination.

TESTING:

  • Downflow  & inflow velocity 

  • Temperature/Relative humidity measurements

  • Non-viable particle counting

  • Room Differential pressure

  • Airflow smoke pattern

  • HEPA filter leaks

  • Cabinet integrity (for Type A1 cabinets with positive-pressure contaminated plenums only)

  • Alarm function verification

  • Blower interlock (for Type B1 and B2 cabinets)

  • Exhaust system performance (for any cabinet connected to the building exhaust system)