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Old 12th January 2018, 03:24 AM

Total Posts: 12
Please Help! Gamma Irradiation - dose audit and source replenishment

Hello all!

I'm a QA Manager in a medical device manufacturing company. We were doing EO sterilization for our products but now we have started to manufacture a device that not suitable for EO but required Gamma irridation. Neither I or company has no past with gamma as we are using EO for many years.
We completed validation process (dose setting, bioburdens, sterility and dose mapping) cooperated with a testing institue. Validation done according to Method 1 as recommended by lab chief. Now it's been 6 months since we perform the validation and we will start production. So we did perform bioburden tests on 10 products from one batch.
I read ISO 11137 however there are two issues that not clear to me. I'll appreciate if you can help me if you have any experience or knowledge on these issues.

1) What does 'dose audit' mean? Is it enough if we test the avarage bioburden level on 10 units of product? Do we need to irridate the products in verification dose and perform sterility every 3 months or only if bioburden level is high? I saw that standard asks for 110 products for dose audit so do we really use all these number of product for dose audits?

2) We received a letter from our irridation sterilizer and they are replenishmenting the irridation source. IQ and OQ will be revalidated by sterilizer. However I wonder if replenishment of source is effecting our PQ validation? Is it enough if we perform only dose mapping or do we need to repeat all PQ process?

Thank you in advance for your helps.

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