Cleanroom Certification

Avista Pharma Solutions offers certification of controlled environments. Our GMP-trained analysts provide services with unmatched quality and integrity. Our CETA-Accredited Cleanroom Services Supervisor provides technical oversight of our program for full cleanroom qualification.

 

Cleanroom Certification

We offer a full range of ISO 14644 testing services for cleanroom certification, including:

  • ISO 14644-1 Cleanroom Certification by Particle Concentration
  • Laminar Flow Hood Certification to manufacturer specification and certified to ISO 5 per request.
  • Biological Safety Cabinet Certification to manufacturer and/or NSF specifications.
  • Recommended Cleanroom Testing Services to include:
    • HEPA Filter Integrity Testing
    • Room Pressurization Measurements
    • Airflow Volume / Velocity Profiling
    • Calculated Room Air Exchange Rates
    • Airflow Visualization Studies
    • Room Recovery Studies
    • Temperature and Humidity Monitoring
    • Chemical Fume Hood Performance Verification
  • Other cleanroom tests as per IEST, NEBB, or ISO

 

Compressed Gas Monitoring

Avista Pharma Solutions offers a range of compressed gas monitoring to support your organization’s compliance with GMP regulations. Compressed gases within controlled environments are expected to meet the viable air and particulate levels of the controlled environments. Compressed gases, considered to be a raw material that have direct and/or indirect product contact, should be subjected to a more rigorous testing and monitoring program. Our experienced cleanroom services staff can assist with establishing the correct testing program and parameters based on your needs. Our testing capabilities include:

 

  • Viable Air Monitoring (Aerobic and Anaerobic)
  • Particulate Monitoring
  • Drager Analysis for Moisture, Hydrocarbons, Carbon Monoxide. Other indicators may be available upon request.
  • Dew Point Analysis
  • USP Nitrogen Identity Testing (Flame and Odor Test)
  • USP Nitrogen Content (GC Analysis)
  • USP Oxygen Content (GC Analysis)