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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. No 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:
- Recovery
Testing
- Particle
Count Testing
- Viable
Microbial Sampling
- Visual
Airflow Testing
- Alarm
Calibration
- Ingress
and Egress Test
- Particle
Containment Integrity and Enclosure Leak Test
- Gauntlet
Breach Air Velocity Test
- Volatile
Hazardous Drug Containment Test -Total Exhaust
- Volatile
Hazardous Drug Containment Test-Partial-Recirculating
- Hazardous
Particle Containment Test
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.
Just because your isolator or glovebox is brand new does not
mean it is working properly!
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