Steam Sterilization Processes in the Pharmaceutical Industry

Event Information
Product Format
Prerecorded Event
Lori Herz, Ph.D.
60 Minutes
Product Description

Master the Technical & Compliance Aspects of Steam Sterilization Processes

Steam sterilization processes, including both autoclaves and steam-in-place (SIP) cycles, are critical components in the manufacture of sterile drug products, and in cell culture and fermentation operations.  As these processes are used to ensure that products are free of microbial contamination, they play a crucial role in delivering safe and quality medicines for patients.   

Let our expert Lori Herz take you through the intricacies of steam sterilization in pharmaceutical and biotechnology processes. This course will focus on both the technical and compliance aspects of steam sterilization operations in the pharmaceutical and biotechnology industries.  This session will discuss:

  • Important concepts, such as aseptic processing and sterility assurance level
  • Equipment that is used and what items are subjected to steam sterilization
  • Theoretical aspects including the properties of saturated steam, kinetics of thermal death  and the definitions of D-value, Z-value, and Fo
  • Steam sterilization operations, starting with the key steps in a typical process and how cycles can be effectively developed  
  • Essential elements of how such processes are validated, based upon regulatory guidance, including the use of biological indicators, temperature mapping tests, and loading pattern studies
  • Requirements for on-going process control, such as periodic requalification and routine testing

Plus, here are the tools and benefits you’ll walk away with:

  • PowerPoint slides of presentation
  • Practical examples
  • Applying the theory
  • Developing a sterilization cycle
  • References for more information on topics presented

Here are few highlights of the session:

  • Introductory concepts: sterility, aseptic processing, sterility assurance level
  • Applications – use of autoclaves and steam-in-place (SIP) cycles
  • Theory of steam sterilization
    • Saturated steam properties, temperature versus pressure
    • Kinetics of thermal death
    • D-value, Z-value, Fo
  • Steam sterilization
    • Equipment
    • Four key steps
    • Cycle development
  • Requirements for compliance
    • Guidances for industry
  • Process validation
    • Biological indicators, temperature mapping and load pattern studies
  • On-going process control
    • Requalification studies
    • Leak testing, Bowie-Dick test

Who should attend?

  • Process development scientists and engineers
  • Manufacturing engineers
  • Production supervisors and managers
  • Quality assurance and quality control leaders

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About Our Speaker

Lori Herz - Pharma Training Expert

Lori Herz, Ph.D. is currently a Professor of Practice of Chemical Engineering at Lehigh University. She is the Associate Director of the Bioengineering Program at Lehigh, where she teaches the Metabolic Engineering and Biotechnology Laboratory courses. Additionally, she is affiliated with the Integrated Product Development program, for which she advises student teams working on their capstone design projects.

Prior to joining Lehigh, Dr. Herz worked at Bristol-Myers Squibb...   More Info
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