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 theirEO 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.

We developed this training utilizing not only the ISO guidance's but the hands-on experience acquired while successfully establishing parametric release for severalmedical device manufacturing companies.  Learn the use of this practical approach which will allow for a simple, straight-forward implementation of parametric release which has been evaluated by the FDA and found in compliance in all of these companies. We will discuss the validation and other requirements along with monitoring methods.

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