Isolator Certification

Air Safe can certify and service all types of isolators and gloveboxes.  This includes Compounding Aseptic Containment Isolators (CACI), Compounding Aseptic Isolators (CAI) used in pharmacy settings as well as Class III atmospheric gloveboxes utilized in high containment facilities.  Not only can we certify the airflow and integrity of the HEPA filters installed, we can also perform leak test on the chambers.

Other important tests which can be performed are:

  1. Recovery Testing
  2. Particle Count Testing
  3. Viable Microbial Sampling
  4. Visual Airflow Testing
  5. Alarm Calibration
  6. Ingress and Egress Test
  7. Particle Containment Integrity and Enclosure Leak Test
  8. Gauntlet Breach Air Velocity Test
  9. Volatile Hazardous Drug Containment Test -Total Exhaust
  10. Volatile Hazardous Drug Containment Test-Partial-Recirculating
  11. Hazardous Particle Containment Test

Isolators can be a much cheaper alternative to renovating an entire pharmacy to comply with USP <797>.  These devices are best suited for low volumes of sterile compounding.  While very effective when used with proper procedures in place, they can be cumbersome for some technicians to use effectively due to the additional movement limitations cause by the glove port access.

Air Safe, LLC recommends the use of unidirectional airflow isolators versus non-unidirectional (turbulent) airflow isolators for clients wishing to comply with the USP <797> document on pharmaceutical compounding.

It has been our experience when performing recovery testing on non-unidirectional airflow isolators, the recovery time can exceed 30 minutes.  The recovery test provides the user of the isolator information about how long it takes the isolator to “recover” to an acceptable ISO Class 5 environment after an introduction of simulated contamination.  Field testing of unidirectional airflow isolators has shown recovery periods of less than one minute.