CfPIE - The Center for Professional Innovation & Education, Boston, MA USA
July 23 & 24, 2018

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

This course provides comprehensive practical information on microbial contaminants and contamination control in modern cleanrooms. Extensive guidance is presented on the daily functions and monitoring necessary to maintain required cGMP microbial and particle cleanliness levels in cleanrooms.

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

Emphasis is placed on attendees sharing information on their practical cleanroom knowledge and experiences with the group.

An extensive appendix providing tables, technical discussions, and scientific literature references is included with the course notes and is intended to provide background material for attendees wishing to go deeper into the subject of cleanroom microbiology.

Who Should Attend

This introductory course is designed for any person who wants to understand the basic methods used to minimize cleanroom microbiological contamination. The course does not assume any knowledge of microbiology by attendees. For those persons who are already working in cleanrooms, but unfamiliar with microbiology, the course will provide basic understanding of why certain procedures are used. Traditional microbial sampling and monitoring and the latest developments in doing these tasks are critically discussed and analyzed.

Jay A. Glasel, Ph.D.

Jay A. Glasel, Ph.D.

Specialties: Biotechnology, Manufacturing

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.

Courses:

• Understanding Sterilization Methods for Products and Devices

Publications:

He is the Senior author of 120 original research articles, invited chapters and invited reviews in scientific publications. He is also the editor of a widely used textbook, "Introduction to Biophysical Methods for Protein and Nucleic Acid Research."

Other Publications:

• "Summary of the MRSA Problem", CIRIscience.org online, November, 2007
• "Cleaning Methods for Ceramic Tile Floors: A Quantitative Comparison of Conventional and Fluid Extraction", Controlled Environments, April, 2008
• "Development of an Optimal Cleaning Program Through ICM: What does measurement mean to you?", CM/Cleaning & Maintenance Management online, February, 2009
• "Bringing Home Something Other than Homework from School: Microbial Contamination from Highly Touched Objects", CIRIscience.org online, July, 2009
• "The All-important Fine Details Underlying an Effective Cleaning and Disinfection Program", Pharmaceutical Microbiology Forum Newsletter, 17(7) July, 2009
• "Restroom Cleaning: Using Science in the Fight Against Design Flaws", CIRIscience.org online, August, 2009
• "The Importance of Correct Sampling and Swabbing in ICM Programs", CIRIscience.org online , May, 2010
• "Detergent Residues on Surfaces—Food for Microbes", CIRIscience.org online, January, 2011
• "Hot Spot Cleaning For Safer Environments", CleanFax online, Fall 2011
• "What The Cleaning Industry Can Learn From Cleanrooms: Standardized, consistent cleaning lends itself to various applications in the JanSan industry", CM/Cleaning & Maintenance Management online, November, 2011
• "Biowarfare in the Restroom", Clean India Journal, February, 2012