Who Should Attend

This is a basic course covering the microbial, scientific, technological, and statistical foundations of sterilization methods. The purpose of the course is to provide fundamental information on the application of sterilization methods in production processes for technicians, engineers, cleanroom designers, and supervisors.  Those who may have knowledge of established processing procedures but lack a clear picture of the scientific principles of microbial destruction will benefit from this course. The course is geared for people without advanced courses in microbiology, chemical/physical science, or sterilization engineering, as well as, those looking for a review of present sterilization methods and future trends in their development and validation..



Learning Objectives

Upon completion of this course, you will:

• Understand the principles and practices of the basic microbiology of procaryotes and eukaryotes applied to their potential contamination of products 
• Understand the principles and methods for microbial detection and identification 
• Know the detailed scientific and technological basis of all contemporary sterilization methods
  • Physical and chemical methods
  • Filtration
  • Water sterilization and standards
• Understand current practices for autoclave, dry heat, and radiation sterilization methods and technologies 
• Have a quantitative understanding of the statistical nature of sterility assurance and its validation
• Understand the role of humans in the potential contamination of products
• Have an overview of present regulatory mandates and guidances on sterilization of products
• Have knowledge of current trends in regulatory thinking on sterilization harmonization

Course Description

The course provides a basic but comprehensive presentation of sterilization procedures as they are now used in the pharmaceutical industry. With an emphasis on autoclave sterilization, the course explores present-day basic scientific knowledge: from the destruction of microbials, to the manufacture of sterile products, and 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.