Product definition for Ethylene Oxide Sterilization Validation

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bacillus killer

#1
Dear all,
I'm designing a sterilization validation and, in general, a sterilization assurance system.
All the products in range were reviewed by a qualified team and only few products were shortlisted, being the most difficult to be sterilized products in range.

Now I have 2 questions:

Q1:
Is it mandatory to select only one "Worst-case product" before entering the sterilization validation (ISO 11135:2014 annex B) or can I start the validation with more than one candidate "worst-case productS"?
Working with an Overkill approach, Can I for example demonstrate the appropriateness of the internal PCD, comparing it with all candidate products in sublethal cycles?

Q2:
Is it mandatory to identify the most difficult to sterilize location within the product?
How this information will be used in following validation steps?

According to ISO 11135:2014 (8.6) "The PCD shall present a challenge to the sterilization process that is equivalent or greater than the challenge presented by the natural bioburden at the most difficult to sterilize location within the product".

In my case I have more than one products / locations but it is still possible to analyze whole product so I suppose there is no need to identify the most difficult to sterilize location to demonstrate the appropriateness of the Internal PCD used during the validation!
Am I right?


Thank you all for your contributes!
 
Last edited by a moderator:
Elsmar Forum Sponsor
#3
I think you can choose more than product to represent the worst case. as the worst case product can be determined from more than attribute, is it the most difficult to be sterilized? , or that it retains more EO residual?

i think in your case , you can place B.I and the products in all locations seemed to be the most challenging places, to get the relative resistance between the B.I and the product.
 
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