GMP Cleanroom Qualification and Re-qualification Testing

Cleanroom Qualification is the overall process of assessing the level of compliance of a classified cleanroom or barrier system (RABS, BSC, Isolator, Pass-box mobile HEPA cart) with its intended use. Different approaches are taken in different parts of the world as well as different testing methodologies. This course will highlight the different testing requirements as well as provide case-histories related to US FDA and International inspectors comments regarding cleanroom qualification testing as well as re-qualification. Attendees will gain a greater understanding of the required testing, and learn from mistakes others have made in the qualification testing of cleanrooms for GMP operations. Various FDA 483 observations and warning letters regarding qualification and testing will be covered. 

As part of the qualification requirements (per international GMP guidance), the qualification of cleanrooms and barrier system should include (where relevant to the design/operation of the installation):

  • Installed filter leakage and integrity testing.
  • Airflow measurement - Volume and velocity.
  • Air pressure difference measurement.
  • Airflow direction and visualisation.
  • Microbial airborne and surface contamination.
  • Temperature measurement.
  • Relative humidity measurement.
  • Recovery testing.
  • Containment leak testing

In the United States, Both Recovery Testing and Containment Leak Testing are not a specific FDA requirements.  American companies that produce medical products in cleanrooms for the international market, especially for Europe,  have been required to perform this testing. 

Instructor

Morgan Polen
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Morgan Polen is the principal consultant for Microrite. Morgan brings 30 years’ experience working in cleanrooms and is a subject matter expert in particle monitoring. He has been involved with various cleanroom projects working in over 40 countries. With hands on experience in projects ranging from cleanroom design, construction, validation, monitoring program development, particle counter design, and product management for cleanroom related products and systems. Addressing monitoring and control solutions in a wide variety of clean industries such as pharmaceutical, medical device, semiconductor, data storage, aerospace, defense, automotive, optical, and food and beverage manufacturing. He has lectured on particle monitoring and contamination control in North America, South America, Europe, Asia, and the Middle East.

Next Date and Location

Tuesday, November 15, 2022
9:00 a.m. - 4:30 p.m. Central Time
During EDUCON 2022
In-person or virtual
Hyatt Regency Chicago - Schaumburg
Schaumburg, Illinois
Registration information

Buy 3 Get 1 Free! Register three personnel from your company for the same course and receive a complimentary fourth registration. Contact IEST for details.