EO sterilization

[summer]

Hi, we have a few questions about sterilization validation.

1. Fractional cycle is used to demonstrate that the relative resistance of EPCD>IPCD>Product. The minimum number of BI/PCDs used in fractional cycle is recommended in Annex C.3 Biological indicators of ISO 11135. We are confused what is the minimum amount of product used for sterility test? Are there any requirements?
2. If the most difficult part of product to be sterilized was previously wrongly determined, but from the test result it can be determined that the resistance of EPCD>IPCD>product. The mistake does not influence the slection of worst-case product in product family. Would the mistake affect effectiveness of the sterilization validation?
3. In Figure D.1 Requalification decision tree of ISO 11135, full requalification is needed if there is significant change. It seems there is not definition of significant change. Does the significant change mean changes that creat a new worst-case condition which may be a new worst-case product, worst-case or most-difficult-to-sterilize location, worst-case loading configuration? How to determine if it's a significant change?

Thanks a lot!

 

[Diman]

Fractional cycle is used to demonstrate that the relative resistance of EPCD>IPCD>Product. The minimum number of BI/PCDs used in fractional cycle is recommended in Annex C.3 Biological indicators of ISO 11135. We are confused what is the minimum amount of product used for sterility test? Are there any requirements?

hi,

As mach I know, the amount of products for sterility test at the fractional cycle are same as IPCD. I'm not sure were to find a reference to this at the ISO.

 

[summer]

Hi,
Thank you very much for your reply.

 

[overandownunder]

Hi,
Thank you very much for your reply.

hi,

As mach I know, the amount of products for sterility test at the fractional cycle are same as IPCD. I'm not sure were to find a reference to this at the ISO.

A bit late but info located in ISO 11135:2014 Annex D 7.1.6
1- We used the "minimum load" count as what is the load you will be validating or have validated for your process.
2- ISO 11135:2014 Annex D 7.1.6 "A means of demonstrating equivalence to a previously qualified product or internal PCD is the comparison of the relative rates of inactivation of BIs placed in a challenge location within the new or modified product and previously qualified product/master product (see D.8.6 and D.12.5.2) when both are exposed to a fractional cycle. Equivalence studies should compare the new or modified product to the internal PCD used to validate the process. If a PCD is used for this comparison, this resistance of the PCD should be assessed as part of the annual review."
3- ISO 11135:2014 Annex D 12.3.3 "Full Qualification – consisting of PPQ and MPQ. This can be required in certain situations, e.g. following a significant change to product/packaging design or configuration (creating a new “worst-case” condition), process design or equipment/service."