Cleanroom Microbiology for the Non-Microbiologist

This course provides practical information on contamination control and cleanroom management. Extensive guidance is presented for the critical daily aseptic maintenance and housekeeping functions necessary to maintain required cGMP cleanliness levels.

Topics to be discussed include:

• Basics of microbial biology and physiology
• Cleanroom design requirements
• Sources of microbial contamination in cleanrooms
• Non-viable airborne particle standards and monitoring
• Airborne and surface microbial standards and monitoring
• Origin and minimization of pyrogen contamination
• Cleaning technologies and operations
• Disinfection and sanitization materials and techniques
• Rapid microbial monitoring methods
• Training methods for proper contamination control

An extensive appendix providing tables and monograph and scientific literature references is included with the course notes.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

Dr. Jay A. Glasel is an internationally recognized scientist with extensive experience in molecular immunology, biochemistry and pharmacology. He is the founder and Managing Director of Global Scientific Consulting, LLC.

Prior to becoming a scientific consultant, he was a Professor in the Department of Molecular, Microbial and Structural Biology at the University of Connecticut Medical/Dental School. He has conducted extended scientific research and delivered presentations at leading science/technology organizations in North America, Europe and Asia.

As a scientific consultant, Dr. Glasel has had many diverse clients in the areas of pharmaceutical R&D, as well as, cleanroom and sterile environment facilities. He has published numerous articles dealing with the general subject of removal of microbial contamination from work areas.

He was awarded a Ph.D. in Chemical Physics at the University of Chicago and holds a B.S., with honors, major in Chemistry, minor in Physics from the California Institute of Technology.