Sterilization Procedures: Introduction to the Science and Methods

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Course Description

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.

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 science and engineering 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 training 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 role of humans in the potential contamination of products
  • Understand the principles and methods for microbial detection and identification including the latest rapid methods
  • Know the detailed scientific and technological basis of all contemporary sterilization methods
    • Physical and chemical methods
    • Filtration
    • Water sterilization and standards
  • Understand current practices and equipment available for autoclave, dry heat, chemical, and radiation sterilization methods and technologies
  • Have a quantitative understanding of the statistical nature of sterility assurance
  • Understand the basic principles and practices for sterilization validations

Past Participants' Comments

"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 - J&J

Frequently Asked Questions

How does this course connect with your course, "Cleanroom Microbiology for Non-microbiologists"?

The beginning few hours of the course (during which basic microbiology is discussed) overlaps between the two courses. However, this sterilization course emphasizes killing microbials in final products whereas the cleanroom course emphasizes removing microbials from the production environment.

I've heard that analysis of sterilization requires a lot of math. Will I be able to understand the subject matter in this course?

The course does involve a quantitative understanding of how effective different sterilization methods are. However, the math involved is simple algebra and is presented step-by-step with detailed explanations at each step so that even participants who have not solved an algebraic equation in a long time will understand what is discussed. There is a short problem session at the end of the course where participants are asked to calculate results of autoclave and radiation sterilization cycles. A hand calculator is all that is needed for this problem session.

What sterilization methods are covered in depth?

All the commonly used methods of sterilization, autoclaving, radiation sterilization, and gaseous sterilization are discussed at a basic level. Quantitative understanding of the development and validation of autoclaving and radiation sterilization cycles is emphasized and covered in depth.

Are sampling methods for sterilization validation discussed?

An important part of the course is an extensive quantitative discussion of what sampling for sterilization validation means and how validations are accomplished.

I see that a discussion of the production of sterilized water is part of the course. Why is this included?

Large quantities of sterilized water are used in the manufacturing of drug and medical devices. The production of sterilized water is therefore a special and important case of the production of sterilized products and an understanding of this unique substance needs to go along with a general understanding of sterilization.