Hi everyone! We are about to conduct sterility testing of our new tetrapak system. Tetrapak has recommended sampling plan and we are going to follow their recommendation, which is ~7000 packs. However, this is my first time to do sterility testing and I have no idea how many samples should I test for microbiology analysis. Does anyone here could share their thoughts? Thanks ahead.
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#1
Rener De Jesus
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Posted 31 October 2017 - 03:02 AM
#2
Tony-C
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Posted 03 November 2017 - 06:34 AM
Hi Rener,
Are you following the Tetra Pak Guideline for Microbiological Evaluation of Commercially Sterile Products?:
TP Sterility Testing Protocols.pdf 259.12KB
86 downloads
We packed and incubated around 10,000 packs per machine when I commissioned a UHT plant a few years ago. Samples before and after events and 5% of the trial product were tested for micro.
Kind regards,
Tony
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#3
Adriathm
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Posted 08 January 2020 - 09:21 AM
Hi, May i understand the different of sterility test and extened shelf life (ESL) test? If i have a new filler running both UHT and pasteurized product, shouldnt the sterility test is sufficient to validate the line performance?
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Posted 08 January 2020 - 11:05 AM
Hi Adriathm,
The difference is the sterility test will check that the processing system and filler is not contaminating your product. The pasteurised product shelf life will then need to be validated as by the nature of the product it will have a limited life.
Kind regards,
Tony
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