Sterilization Procedures: Technology, Equipment and Validation™

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..

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

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.

“Excellent course!  I wish I would have taken it several years ago.”
Craig K., Regional Manager, JEOL USA

“Very clear explanations of the technical aspects of various sterilization processes.  Gives the attendee a good working knowledge of how these processes work and their effect on microbial contamination!”
Tom H., Product Manager, Colder Products Company

“Excellent course to review sterilization from basic microbiology through methods and current regulations.  I would recommend this course for anyone in manufacturing or engineering.”
Daniel M., Director of Engineering, Surgical Specialties Corporation

“This is a very good source of information for professionals to better understand and increase job performance.”
Celia E., QA Supervisor, Medtronic Mexico

“Good training course!”
Barbara H., Sr. Sterility Assurance Tech., Arthrex Manufacturing

“Great information and very helpful for those just starting out in the business.”
Ashley L., Quality Engineer, Ethicon Products J&J