Sterilisation Validation - VDmax for e-beam

Sam Lazzara

Trusted Information Resource
#11
Hello

I would like feedback on the following scenario:

For e-beam sterilization, it is acceptable to do a verification dose with sterilization provider -X- and then, the dose mapping with another sterilization provider -Y- with the intention to use sterilization provider -Y- for routine sterilization processing.

:thanx:
Dear csterling,

Absolutely yes. That is actually the typical scenario. Verification doses have a very tight tolerance (+/- 10% I think) that cannot typically (for gamma at least) be met in a typical production process. Also, all verification doses must include their own dose mapping.

In your example, provider Y is your production provider and they would need to perform dose mapping in support of your routine processing with them. This is typically done initially and only updated if you change your load configuration.
 
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patelj

#13
hi,
we have been following VDmax25 method to establish the sterilization dose for our medical device. We could achieve the required sterility level , however the performance of product is affected at this dose. Is there any way we can modify the sterilization dose to achieve the optimum performance. The ISO11137 standard only states requirement of desired sterility level but nothing about the functionality testing.

Can anyone guide for E beam sterilization dose setting and validation
 
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