Quite Involved in Discussions
Dear All,

Due to the delays in the regulatory approval, our medical device (syringe) now have a manufacturing gap of 1 year. Last year we performed a full gamma validation (VDmax25) that included the dose mapping.

We manufacture other products at our clean room and regularly monitor environmental monitoring data and bio-burden determination of few products (they are not kind of products though).

Considering there are no major changes in the design and packaging can we conduct partial gamma validation? (as below)

? Bioburden determination on 10 samples
? Dose verification (10 sample with ref to table 9 ISO 11137-2)
? Sterility test (accept if no more than one positive test obtained)
? Prepare partial validation report (summarizing details)

Just want to know am I on right track or we need to perform a full validation along with dose mapping?




Quite Involved in Discussions
I don't believe this is a valid approach, you should validate the new products from scratch

Its not clear to me what the existing valdiation is for, you suggest that you manufacture other sterile products but say they are not the same. You then go on to say that there are no major changes to design or packaging

The standard gives a whole list of things that would require revalidation, I can't remember them off the top of my head but you should review that list.

It is possible to validate a worst case scenario but you have to be able to be able to state your assumptions and justify your decision making.


Quite Involved in Discussions
My apologies, i wasnt clear with my question. The device is in question is the same, I mean we validated our Syringe last year and because we havent received approval for the same, there was delay in manufacturing of one year. Now we have device approved and ready to go to the market. Although, there is gap of one year, we would like to ensure that the Syringe achieves SAL of 10-6

As we have already validated Bioburden method and sterility we only required to perform bio-burden determination and sterility testing (no need to validate product for bio-burden and sterility).

As per my information if there is no any change related to the device including packaging we can prove partial validation. We will opt this approach as product will be intermittent (that is there will be gap of more than 3 months). So, we have to do partial validation for every production run untill sufficient history established. Dose mapping we will need not do as the sterilizer has not changed their gamma source. When the sterilser provider will change the gamma source we will perform dose mapping again.

By doing the partial validation we might able to save some money.


Quite Involved in Discussions
I hope someone else with more experience in sterilisation can offer there advise here -

I have a vague recollection of the standard and what you suggest in this case seems to be valid, but there has been a significant change that you have to consider....time!

sorry I can't be any more helpful


Quite Involved in Discussions
I have reviewed ISO 11137 and confirmed with our sterilisation facilitator, I guess we are on right track.

If anyone are having some other ideas please share


Inactive Registered Visitor
I agree that you are on the right track. Although my experience has been in ETO sterilization, my advise would be to consult with your sterilization provider since they see all the ins and outs of what is allowed and what is prohibited.


Quite Involved in Discussions
Yes, I confirmed with the sterilisation provider and yes the path we have selected is acceptable as long as I document all rationale. Thanks for your help.