Pharma / Biotech
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.
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.
Basic Microbiology Applied to Sterilization
The Working Environment
Basics of Terminal Sterilization Methods
The Time Course of Microbial Death in Sterilization Processes
Understanding Validated Sterilization Procedures
Practical Sterilization Cycles
Preparing Sterile, High Purity Water
Major learning objectives of this course:
"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
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.
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.
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.
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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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