This three-day cleanroom certification training program uses lecture, hands-on workshops and group activities to provide the knowledge needed to test HEPA filters and the support systems in regulated cleanrooms and controlled environments. Participants learn about the FDA’s Aseptic Guidelines, and relevant ISO and US standards.

Participants Will Learn To:

• list regulations and guidelines that need to be considered when certifying cleanrooms
• describe strategies for certifying cleanrooms and HEPA filtered devices
• correlate specific procedures with particular applications
• explain principles of HEPA filtration
• describe the operation of testing equipment, including aerosol generators, photometers, and particle counters
• perform in-place HEPA filter integrity testing to show particles will not be able to enter controlled environments
• verify the capability of the cleanroom system to maintain the specified pressure differential between cleanroom and surrounding areas
• calculate air exchange rates to show that if a particle does enter the controlled environment, the particle will be disposed of in a timely efficient manner
• document airflow patterns by using smoke and video
• do statistical analysis of particle counts to show that the controlled environment can maintain desired room classification
• determine if a facility meets the specified ISO 14644-part I classification

Who Is This Class For?

• Validation
• Quality Assurance and Contamination Control Personnel
• Facility Engineers
• Maintenance Personnel
• Cleanroom Certifiers
• Architects and Engineers involved in cleanroom design