FAQ: Testing HEPA Filtered Systems and Pharmaceutical Cleanrooms vs. Certification of Sterile Compounding Facilities and Aseptic Isolators

What’s the Difference Between our Testing HEPA Filtered Systems and Pharmaceutical Cleanrooms and Certification of Sterile Compounding Facilities and Aseptic Isolators classes?

Choosing the right training course depends on the type of facility you work in and the standards you must follow. Use the questions and answers below to guide your decision:

Questions to Consider

  1. What type of facility are you testing?
    • GMP facility – Testing HEPA Filtered Systems and Pharmaceutical Cleanrooms
    • Compounding facility or pharmacy – Certification of Sterile Compounding Facilities and Aseptic Isolators
  2. Who regulates your facility?
    • The FDA who follows GMP (Good Manufacturing Practices) – Testing HEPA Filtered Systems and Pharmaceutical Cleanrooms
    • FDA, Boards of Pharmacy, Department of Health and/or Joint Commission following USP general chapters – Certification of Sterile Compounding Facilities and Aseptic Isolators

Testing HEPA Filtered Systems and Pharmaceutical Cleanrooms

Best for:

  • 503B Compounding Facilities/Pharmaceutical Manufacturing

Standards Covered:

  • GMP (Good Manufacturing Practices)
  • ISO 14644 Standards
  • Pharmaceutical Manufacturing GMP Standards / 503B
  • IEST Recommended Practices

Topics Taught:

  • Air particle counting
  • Room air exchange
  • Airflow pattern visualization
  • Standards and regulations
  • HEPA filter integrity testing

Certification of Sterile Compounding Facilities and Aseptic Isolators Training

Best for:

  • Sterile compounding
  • Pharmacies (503A)
  • Smaller or mid-sized 503B cleanroom facilities

Standards Covered, as pertains to certification:

  • USP Chapters 795, 797, 800, 825
  • ISO 14644-1
  • Ceta Application Guides (CAG’s)

Topics Taught:

  • Airflow testing
  • HEPA filter integrity testing
  • Particle counting
  • Environmental monitoring
  • Dynamic airflow smoke pattern testing

Equipment Used in Both Classes

  • Photometer
  • Aerosol generator
  • Capture Hood
  • Particle counter
  • Various Fog generators
  • Thermal Anemometer (for airflow)
  • Manometer (for room pressure)

If you’re unsure which class fits your needs, we’re happy to help you choose the best option based on your facility and regulatory requirements.