Gamma Sterilization: Change in Bulk Density vs. Revalidation

S

skipfarinha

#1
We changed a product so that the bulk density has increased 1.8%. We gamma sterilize the product and all the materials are the same. My question is: "What is the rule of thumb and at what increase in bulk density do we need to revalidate and perform a new dose study?" Thank-you.
 
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D

Denis

#2
The control parameters for the products that we irradiate are weight and physical case dimensions.

If a product varies by more than 10% of its original irradiation validation, then we have to have a re validation with the new characteristics.

Same applies if the packaging configuration within the product unit alters.
 
J

jscholen

#3
I think you would be justified with such a small increase....I don't know what the material content is, but if it is not dense material, then you might justify it a "negligible" effect.

If you have a notified body at your disposal, you can probably get an opinion from them as to the applicability of your current validation to this new configuration....but I would have your justification written up first and then submit it to them for review.
 
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