Sterilization: Processes & Validation

Sterilization: Processes & Validation
October 12-14, 2010 - Princeton, NJ

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Course Description

This course covers the entire range of sterilization processes utilized in the pharmaceutical, biotechnology and medical device industries. It begins with a review of the microbiology of sterilization, and how that relates to sterilization process selection, cycle development, operation and validation. Sterilization methods to be covered in the course include:

  • Steam sterilization for porous loads (fill parts, stoppers, utensils, etc)
  • Terminal Sterilization for products, intermediates and media
  • Steam sterilization-in-place (SIP for tanks, freeze dryers, bioreactors, etc.)
  • Dry heat sterilization and depyrogenation (ovens and tunnels)
  • Gas sterilization for materials and equipment (medical devices and intermediates)
  • Vapor and liquid sterilization (including isolator decontamination)
  • Radiation sterilization (gamma, electron beam and other methods)
  • Filtration sterilization for liquids and gases
  • Emerging sterilization methods

An overview of the validation requirements for each of the sterilization methods will be provided. Regulatory expectations for compliance and submission applicable in the US and rest of the world will be included.

Who Should Attend

This course is intended for individuals requiring an in-depth knowledge using sterilization processes. Those experienced with sterilization technology can refine their knowledge of the subject through comprehensive treatment of the subject matter. Those without a background will learn the fundamentals of sterilization processes, before progressing into details of the sterilizing methods. The course is appropriate for personnel working in production, R&D, QA/QC, engineering, validation, microbiology, and regulatory affairs. Examples of applications for pharmaceuticals, biologics and medical devices will be utilized.

Your Instructor

Jim Agalloco

James Agalloco is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry. Since the formation of Agalloco & Associates in 1991, Jim has assisted more than 100 health care firms in a wide range of validation, automation and compliance areas. Jim has over 35 years of industry experience and has worked in organic synthesis, pharmaceutical formulation, pharmaceutical production, project and process engineering, validation and process automation during his career at Merck, Pfizer, Squibb and Bristol-Myers Squibb. He received his BS in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979. He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983. He is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He is a member of USP's Microbiology and Sterility Assurance Expert Committee for 2005-2010. He is a frequent author and lecturer on the subject of sterilization, aseptic processing and process validation.

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