Sterilization Procedures: Technology, Equipment and Validation

Who Should Attend

This is a two-day 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 of operations who may have knowledge of established processing procedures but lack a clear picture of the scientific principles of microbial destruction.

The level of the material presented is geared for those without advanced level courses in microbiology, chemical or physical science, or sterilization engineering, and for those wishing 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
• The methods and principles for microbial detection and identification 
    -  Presently used methods
    -  Future trends
• The role of humans in the potential contamination of products
• The detailed scientific and technological basis of all contemporary sterilization methods: 
    - Physical and chemical methods 
    - Filtration 
    - Water sterilization and standards 
    - Emerging technologies
• The regulatory mandates regarding sterilization of products
    -  Present regulations and guidances
    -  Introduction to risk analysis and process analytical techniques (PAT)
    -  Cleanroom standards
    -  Trends in regulatory thinking and practice
• The statistical nature of sterility assurance and its validation

Course Description

The course provides a basic but comprehensive presentation of sterilization procedures as they are now used in the pharmaceutical industry. The content of the course emphasizes the practical application of present-day basic scientific knowledge to the destruction of microbials, to the manufacture of sterile products, and to validation of the sterilization procedures used. After you complete this course you will be able to 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. You will also be presented with the trends in regulatory thinking applied to aseptic processes and in possible near-term future technological developments in sterilization methods and in microbial monitoring techniques.