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Frequency of Sampling for High Acid Commercially Sterile Products

aseptic microbiology commercial sterility

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#1 shannonw

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Posted 24 March 2021 - 07:03 PM

Good Afternoon, I work in an apple processing facility that has traditionally produced dehydrated RTE and fresh slice products for further processing. These products are classified as low risk and we have a very basic sampling program in place to test for standard micro for each production lot (APC/Coliform, E.coli, Y&M) all using 3M petrifilm. My company wants to expand our processing line to include an aseptic puree line to process and aseptically package bulk puree into hermetically sealed bulk 1000L totes. We will be processing high acid products ie, apple puree and I will be writing test methods for our lab based on the commercial sterility/ canned foods testing standard from the Canadian HPC Compendium (MFHPB-01).  I anticipate capturing ~ 5L samples from the filler into aseptic sampling bags for analysis and shelf life.My question is, what frequency of testing should I begin with to verify commercial sterility for a daily production lot? (the aseptic process itself will be validated by a Process Authority). The commercial sterility test is time consuming and I don't want to commit to oversampling. I don't have any guidance on a target defect rate or confidence level ( i.e 1 in 1000 at 90% confidence). Would sampling at Beginning, End and once every 8 000 L (which is approx. once every 4 hours) be sufficient for a one day production run (estimated volumes are 30 000L/ 16 hour day)?  We will also be verifying sanitation with ATP and anything else I can think of. I still have to write the risk analysis for frequency of micro testing etc. but I'd like a rough estimate of # of samples so that I can plan the testing capacity of our future micro lab. Is there anything that I am missing completely here? I've worked in many micro labs over the years but haven't personally developed the sampling programs and have never worked in a canning facility. I see a lot of information for the low acid canned foods but not for high acid..... Any suggestions would be appreciated. Thank you :)



#2 Charles.C

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Posted 25 March 2021 - 03:07 PM

Good Afternoon,

I work in an apple processing facility that has traditionally produced dehydrated RTE and fresh slice products for further processing. These products are classified as low risk and we have a very basic sampling program in place to test for standard micro for each production lot (APC/Coliform, E.coli, Y&M) all using 3M petrifilm.

My company wants to expand our processing line to include an aseptic puree line to process and aseptically package bulk puree into hermetically sealed bulk 1000L totes. We will be processing high acid products ie, apple puree and I will be writing test methods for our lab based on the commercial sterility/ canned foods testing standard from the Canadian HPC Compendium (MFHPB-01).  I anticipate capturing ~ 5L samples from the filler into aseptic sampling bags for analysis and shelf life.

My question is, what frequency of testing should I begin with to verify commercial sterility for a daily production lot? (the aseptic process itself will be validated by a Process Authority). The commercial sterility test is time consuming and I don't want to commit to oversampling. I don't have any guidance on a target defect rate or confidence level ( i.e 1 in 1000 at 90% confidence). Would sampling at Beginning, End and once every 8 000 L (which is approx. once every 4 hours) be sufficient for a one day production run (estimated volumes are 30 000L/ 16 hour day)?  We will also be verifying sanitation with ATP and anything else I can think of. I still have to write the risk analysis for frequency of micro testing etc. but I'd like a rough estimate of # of samples so that I can plan the testing capacity of our future micro lab.

Is there anything that I am missing completely here? I've worked in many micro labs over the years but haven't personally developed the sampling programs and have never worked in a canning facility. I see a lot of information for the low acid canned foods but not for high acid..... Any suggestions would be appreciated. Thank you :)

 

Hi shannonw,

 

Regret unfamiliar with the "standards' you refer but an answer to yr query presumably,  initially, will depend on how you quantitatively estimate achievance of commercial sterility ? Offhand, I would have thought impossible for the process you initially refer to.

 

Maybe you now plan to do some canning/measure APC and apply a maximum limit ? Or ?


Kind Regards,

 

Charles.C






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