Sterilization Procedures: Introduction to the Science and Methods

The course provides a basic but comprehensive presentation of sterilization procedures as they are now used in the pharmaceutical and medical devices industries. The course explores the practical application of basic scientific knowledge to the destruction of microbials in the manufacture of sterile products and the validation of the sterilization procedures used. Upon completion of this course, attendees will understand how and why specific sterilization methods are used in particular applications, how the methods are validated, and the strengths and weaknesses of different sterilization methods. Attendees will have exposure to quantitative analyses of microbial destruction, sterility sampling, sterility assurance, and sterilization cycle development. Participants will also be presented with the trends in microbial monitoring techniques.

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.