Gamma Irradiation Process Validation Help

alonFAI

Involved In Discussions
#1
Guys Hello

I have a question regarding process validation for Gamma Irradiation.
one part of the validation includes dose verification.
this is done by initially calculate an average Bioburden, then apply the calculated dose to the items and then perform a sterility test.
now, lets assume I manufacture my medical device in 2 different facilities (i.e. I have a second source) should I perform the Gamma Sterilization Process Validation twice? one time for products manufactured in facility 1 and another time for products manufactured in facility 2?
it does make some sense since part of the Gamma irradiation process validation includes calculation of the Average Bioburden level, and the Bioburden level is also depends on the specific facility were the products are manufactured.

thanks!!:thanx:
 
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shimonv

Trusted Information Resource
#2
Hi Alon,
Yes, you should repeat the process validation for the second site.
You must demonstrate that the calculated dose is sufficient to sterilize items coming from the second site which, quite likely, will have a somewhat different Bioburden level. It's difficult to rationalize your way out of it.
Also down the road, as changes occur and not necessarily in both sites simultaneously, you will need to repeat the validation process.

-Shimon
 
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