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Date: 9th - 11th February, 2010

Location: Cork, Ireland

Summary:
Cosmetic, Pharmaceutical - Training

Providing both a theoretical foundation and a practical application of sterilisation equipment, this course gives detailed guidance on current requirements for qualifying steriliser equipment and validating sterilisation processes. The GMP expectations for the routine operation, monitoring and control of sterilisation processes will also be discussed together with practical examples of how these techniques are applied through appropriate engineering to ensure reliability in full compliance with all European and US regulatory requirements. Finally the ongoing operational, maintenance, thermal and biological validation requirements will be examined in detail.

Course Content Includes:

• Introduction to Sterilisation
  


• Principles of Moist Heat Sterilisation
  


• Steam Quality
  


• Dry Heat Sterilisation and Depyrogenation
  


• Instrumentation and Control of Sterilisation Processes
  


• Quality Systems Associated with Sterilisation Processes
  


• Auditing Sterilisation Processes and Preparing for a Regulatory Inspection
  


• Biological Indicators
  


• Validation Strategies for Sterilisation Processes
  


• Routine Operation of Sterilisers