Aseptic Isolators play an important role in compounding, pharmacy, and high containment facilities. They are designed to protect the product or process, not for operator protection. An isolator separates a product or process from its production equipment, technical personnel, and surrounding work environment. They are used in applications requiring a high degree of protection from external elements or contaminants, and they can also serve as alternatives to sophisticated cleanrooms.
Isolators are usually equipped with air filtration systems capable of lowering a particle count in an enclosed area, and it is easy to clean their interiors with gas or vapor sterilizing agents. A positive air pressure is maintained to prevent contaminants from entering the device, while work is done through sealed glove assemblies.
|NOTE: If Compounding Aseptic Isolators 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, Compounding Aseptic Isolators must be certified at time of installation and at least annually thereafter.
In addition, re-certification should be performed whenever HEPA filters are changed, repairs are made, or the isolator is relocated. More frequent re-certification intervals should be considered for particularly hazardous or critical applications or workloads.
Isolator Primary Tests (must pass to be certified)
- Document customer, location, and area device is located
- Device ID#, manufacturer, model number, serial number, and type of device tested
- Pre-filter information, if feasible
- Airflow (velocity) tests – The following must be performed for each:
Main Work Chamber • Pass-through Chamber • Egress Opening • Pass-through Opening
- Chamber Pressure Testing – Main Chamber & Pass-through
- Site installation assessment tests
- HEPA filter leak/challenge test (Integrity Test)
- Particle Containment Integrity & Enclosure Leak Test
- Airflow smoke pattern test
- Preparation Ingress and Egress Test
- Non-viable airborne particle count test
Isolator Optional Tests
- Gauntlet Breach Air Velocity Test
- Recovery Time Determination Test
- Volatile Hazardous Drug Containment Tests
- Hazardous Particle Containment Test
- Pass-through Particle Purge Time Determination Test
Detailed Summary Report: