Testing and Certification

There is no room for error when it comes to safety and compliance in your Life Sciences facilities.

Another DENS’ Client Benefit

Rigorous testing and certification ensures that your facilities and laboratories are operating as effectively as possible – delivering optimal benefits for the research projects depending on that equipment.

Biological Safety Cabinets (BSCs)

We certify biological safety cabinets to meet NSF/ANSI 49 section Annex F Field Certification as well as the manufacturer’s specifications.

Primary Tests

  • Inflow velocity measurements
  • Downflow velocity measurements
  • HEPA filter integrity testing
  • Airflow visualization testing
  • Site installation testing and alarm calibration
  • Non-viable particle counting (optional)
  • Worker comfort and safety testing, including electrical safety, vibration, sound, & fluorescent/UV light (optional)
  • Decontaminate BSCs with vaporized hydrogen peroxide bioquell equipment.

Cleanroom Testing

We test and certify cleanrooms to ISO 14644-1, ISO 144544-2, ISO 144644-3, and EU Annex 1 to ensure they are functioning to specific parameters and ISO classification.

Primary Tests

  • Airflow volume/velocity readings
  • Room air exchange rates
  • HEPA filter integrity testing
  • Non-viable particle counting
  • Temperature/relative humidity testing

Optional Tests

  • Air balancing
  • Airflow visualization testing/smoke testing
  • Lighting, vibration, & sound testing
  • Cleanroom recovery testing

Chemical Fume Hoods

DENS’ comprehensive ASHRAE 110 certification and face velocity testing of chemical fume hoods ensures this critical equipment is tested in accordance with AIHA/ANSI Z9.5, SEFA, ASHRAE 110, and OSHA.

ASHRAE 110 Testing

  • Inflow (face) velocity profiling
  • Airflow visualization testing
  • Cross draft airflow testing
  • Tracer gas containment test
  • Airflow alarm installation & calibration
  • Inflow (face) velocity profiling
  • Small & large volume smoke testing

HEPA/ULPA Filters Testing

We test HEPA filters to IEST-RP-CC006.3, IEST-RP-cco34.4, and ISO 146644.3 standards. HEPA filters can be tested as individual, unique devices as opposed to a portion of a larger cleanroom. HEPAs, which are a portion of other equipment such as glass washers, HEPA vacs, or process equipment, can also be tested. The main reasons for testing the filters are:

  • Qualification – installation testing
  • Leak testing
  • Health & safety requirements


Isolators are used in general industry as well as compounding pharmacies. There are two types of isolators: positively pressurized aseptic isolators (CAI) and negative containment isolators (CACI). Both are primary engineering controls designed to meet the needs of USP Standards <797> and <800> for the compounding pharmacy.

Isolator Tests

  • HEPA filter integrity testing
  • Airflow velocity &/or volume
  • Chamber pressure testing
  • Work zone sterility testing
  • Product ingress/egress testing
  • Recovery time determination
  • Glove/sleeve breach testing
  • Glove port/sleeve push/pull testing
  • Interchange particle purge time determination
  • Particle containment integrity testing – CACI only
  • Volatile hazardous drug containment – CACI only
  • Interchange particle purge time determination – CACI only
Certification Icon

Our technicians are NSF certified and maintain training through the Eagleson Institute.