Quality Digest

This Ethylene Oxide Sterilization training will discuss the implementation approach for parametric release in EO sterilization as per EN/ISO 11135 guidances.

Areas Covered in the seminar:

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

More Info

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