Industries: Pharma / Biotech

Understanding Sterilization Methods for Products and Devices

Course Director: Jay A. Glasel, Ph.D.

Course Description - Course runs 9:00 to 5:00 both days

The course provides a basic but comprehensive presentation of sterilization procedures as they are used in the pharmaceutical and medical device industries.After you complete this course you 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 methods. You will understand what equipment is used in sterilizations, sterilization cycle development, sampling of products for sterility, and sterility assurance.You will also be presented with the latest developments in the microbial monitoring techniques used in sterility estimations.

An extensive appendix providing detailed discussions of some sterilization topics and scientific literature references is included with the course notes. The purpose of the appendix is to provide supplementary material for attendees who wish to go deeper into specific aspects of sterilization after the course.

Who Should Attend

This basic course covers the commonly used methods for producing sterile products including terminal sterilization and aseptic processing. The course is designed for any person interested in understanding what the concept of sterility means and how it is achieved in practice. No previous knowledge of microbiology or any method of sterilization is assumed.

Course Agenda

First Day

Basic Microbiology Applied to Sterilization

  • Physical properties and internal structures of mycoplasmas, bacteria, and fungi
  • The compositions, properties and practical importance of bacterial cell walls
  • Exotoxins, endotoxins, and sterilization
  • The growth of bacteria in products and in the manufacturing environment
  • Special states of bacteria: spores, biofilms, dormancy

The Working Environment

  • Microbial contamination of products; sources and interactions within the workplace
  • People in the workplace and their role in contamination of products
  • Aseptic products

Basics of Terminal Sterilization Methods

  • Moist heat sterilization
  • Dry heat sterilization
  • Ionizing radiation sterilization
  • UV radiation
  • Chemical sterilization
  • "Sterilization" by filatration

Second Day

The Time Course of Microbial Death in Sterilization Processes

  • Analysis of decreases in microbial populations
  • What is sterilization?: The concept of sterility assurance

Understanding Validated Sterilization Procedures

  • Types of sterilization cycles
  • The use of biological indicators

Practical Sterilization Cycles

  • The parameters describing sterilization cycles
  • Biological indicators and their D-values
  • Performing and maintaining validations

Sterility Testing

  • Sampling products for sterility assurance
  • Corrective action/preventative action plans and out-of-specification investigations

Preparing Sterile, High Purity Water

  • Monitoring water purity
  • Monitoring for biofilm formation

Learning Objectives

Major learning objectives of this course:

  • To understand the principles and practices of basic microbiology applied to prevention and elimination of product and device contamination
  • To understand the basis and practices used in all contemporary sterilization methods
    • Dry and Wet heat methods
    • Chemical methods
    • Radiation methods
    • Production of sterile products using aseptic processing
    • Production of sterile waters
  • To understand how sterility is determined, what sterility assurance means, and how it is validated
  • To understand the role of humans in the potential contamination of products


"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"?

A few of the microbiology topics covered during the first hours of the course overlap. However, this sterilization course emphasizes producing sterile products whereas the cleanroom course emphasizes removing microbials from the production environment.

Are sampling methods discussed?

An important part of the course is an extensive quantitative discussion of what sampling for sterilization validation means, how sampling is done, how the results are analyzed, and what the results mean.

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.