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Details

The use of ETO sterilization process has been worldwide accepted for more many years. The process has proof of it compatibility to many of disposable plastic medical devices with very minimum potential of risk.
The ETO Validation processes shall need to be in accordance to the ISO 11135 guidance standard for ETO validation processes.

Outline

  • Process Validation, definition and current approaches
  • Important of Validation in Technical Documentation requirement
  • Understanding risk assessment as part of process validation
  • Understanding the ISO 11135 standard for ETO validation
  • Pre-requirement prior for ETO Validation
  • Biological Indicator and PCD preparation
  • Validation methodology: IQ/OQ/PQ
  • Validation documentation and support
  • Post Validation requirement
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