300 Colvin Woods Pkwy
Tonawanda, NY 14150, USA

Aseptic Isolator Testing & Certification

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 Clonidine Online 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:

Standards Utilized:

  • All performance testing datasheets contain reference number, testing standard used, date of test, and person who performed the testing.
  • A comprehensive computer generated report will be furnished indicating any required recommendations.
  • Prepare and submit a budgetary proposal for any items deemed defective and/or requiring repair.
  • CETA, Controlled Environmental Testing Association
  • IEST, Institute of Environmental Science and Technology
  • ISO 14644, International Organization for Standardization
  • ACGIH, American Conference of Governmental Industrial Hygienists
  • Manufacturer specifications