How to Implement Parametric Release in EO Sterilization - A Practical Approach

This webinar will present a practical approach for implementing parametric release in EO sterilization. We will discuss the cycle validation and other requirements for implementation of parametric release in EO sterilization as per EN/ISO 11135.

Why Should You Attend:

Even though many companies are utilizing the advantage of parametric released for their EO sterilized products, there are some which still thinks is too complex or risky to be implemented. Latest EN/ISO 11135 and TIR 20 revisions clearly defines the validation requirements but since it does not provides guidance on how to establish the parameters many sterilization experts has doubts regarding this critical aspect.

Areas Covered in the Seminar:

• Introduction.
• Cycle Validation for parametric release.
  • Microbiology requirements.
    • Methods A or B
  • Equipment Requirements
    • Pre-conditioning
    • Sterilization
    • Aeration
  • Product considerations
    • Pallet configuration
    • Product density
  • Parameter Establishment for routine monitoring
    • Humidity
    • EO concentration
    • Product temperature
• Routine EO cycle monitoring.
  • Equipment requirements
  • Processing requirements
• References

Who Will Benefit:

This seminar is designed for professionals with responsibility for validating or making decisions related to the EO sterilization process.

• Sterilization/Quality Managers
• Directors and VP of manufacturing/ quality
• Quality or laboratory personnel
• Product Managers
• Regulatory Affairs
• Quality or laboratory personnel

Event Details:

Date:              September 11, 2012

Time:              10:00 AM - 11:00 AM PDT

Cost:              $249 per attendee per computer terminal

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