Re-sterilization of product which sterilization date is expired

[RAVI12081979]

Dear all

Can any one have the answer of this question?

Can we re-sterilized the product?
If yes, can we re sterilize the expired product? Can regulation permit...

we are manufacturing product which is class IIb and implanted and stay in side the body till the life.. We are printed sterility expiration date on carton....How we can re-sterilized without violating law?

Second Question :

How can we increase the Shelf life of product greater than 5 years?

Thanks

[ontheopenroad]

In order to re-sterilize the product, you would need to validate that multiple sterilization cycles does not impact the safety or function of the device. You would perform the same testing on product which has been re-sterilized as you did when you validated the product after initial sterilization to show that multiple cycles does not negatively impact the product.

In order to validate a shelf life greater than 5 years, you would perform the same testing that you performed to validate the 5-year shelf life, using product that has been aged using the "new" shelf life. This can be performed on product using accelerated aging, but should also be followed up with real-time studies.

[RAVI12081979]

thanks ...

but my question is slightly different ...can regulation permit me to do the re-sterilization of Expired product...
As Material characteristic is not alter with re-sterilization...and even i have tested the product 1 year after expiry and sterility test is pass...

Can regulatory authority permit to give 6 year shelf life base on long term stability study data..?

awaiting your reply...

[ontheopenroad]

Which regulation--which country do you sell in?

[MIREGMGR]

I agree with OTOR's comments, but additionally:

In a normal sterilization/packaging validation, several considerations are validated for the stated sterile-product life: the sustained sterilization of the product to the required probability throughout the stated lifetime, the stability-performance of the sterile-barrier packaging throughout that lifetime, the overall performance of the packaging systems during the allowed shipping methods so as to deliver the sterile barrier packaging integrally, and the stability-performance of the product itself at the end of that lifetime.

If product that is already aged to sterility-expiration (say, five years) is to be re-sterile-barrier-packaged and re-sterilized, that product will be ten or more years old by the expiration of the second round of sterilization/packaging. Thus the validation process for that second round should verify stability-performance of the product itself, not just after the appropriate number (2+1?) of sterilization cycles, but also after that ten-or-more-years life, not just five years (or whatever).

[Duke Okes]

In Reply to Parent Post by RAVI12081979

thanks ...
but my question is slightly different ...can regulation permit me to do the re-sterilization of Expired product...As Material characteristic is not alter with re-sterilization...and even i have tested the product 1 year after expiry and sterility test is pass...Can regulatory authority permit to give 6 year shelf life base on long term stability study data..?awaiting your reply...

Regulatory authority can only permit what you have validated.

[sadeghi]

we ,afzarpezeshk, serching companies based in turkey to re-sterilization amoung our previously purchased products,there are some hip and knee
prosthesis in there manufactured paking,but their sterilzation period is expired.We need them to be re-sterilized
thanks

[bharatbuk]

Re-use and re-sterilization will cause deterioration. To avoid failure in use, products should be checked and any product showing signs of deterioration must be discarded.All products indicated for re-sterilization should be thoroughly cleaned immediately after use.