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October 2019


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"Dr. Michael J. Miller" <[log in to unmask]>
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Thu, 3 Oct 2019 16:29:14 -0400
text/plain (99 lines)
Hi Sam. A number of my clients have the BACTEC or BacT/ALERT. We have been validating these systems to provide comparable results to the USP test with, on average, 5-7 days incubation. 


The minimum time to incubation will depend on the panel of organisms challenged into the system, which may include stressed organisms, slow growers or fastidious cultures. Your panel should include compendial organisms, facility isolates and/or organisms isolated from failed sterility tests, media fills or in-process or pre-filtration samples.


For validation, you should consider Limit of Detection and Equivalence, at a minimum, compared to the USP 71 test. Guidance for validation can come from PDA TR 33, USP 1223 and even Ph Eur 5.1.6.


As for stressed organisms, I have used sub-lethal heating for a few minutes for vegetative cells and incubation at 2-8 deg C for one week for spores. 


Please contact me if you would like additional guidance at [log in to unmask] or for additional information visit the tutorial pages at  The website also provides information on regulatory expectations for validation and a new page on sterility testing of gene and cell therpay products (ATMP) where you can justify using smaller test volumes than the current compendial method.




From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of sam taba <[log in to unmask]>
Reply-To: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date: Wednesday, October 2, 2019 at 9:57 PM
To: <[log in to unmask]>
Subject: Re: [PMFLIST] Sterility USP 71 & USP 797


Dear all, thanks you so much for your input .here are more questions &

infos that some of you have requested:


the system is  BD BACTEC FX. the product tested for 5 days sterility with

this system is CSPs ( compound sterile preparation) in a clean room

facility. This system is also used bor blood sterility testing.

They add 5-10 ml of product to this system( a bottle of BActec Fx) and

incubate 30-35C for 5 days then if turbidity is there they will do ids if

not product is released


Is this easy to validate and have a good comparison results for

equivalency, suitability, etc..?

How about stressed/fastidious microorganisms?

What would be the best approach to validate this?


Looking forward to  having your valuable input again

Have a great day to all


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