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October 2019

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Subject:
From:
Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 1 Oct 2019 11:38:08 -0400
Content-Type:
text/plain
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text/plain (268 lines)
Dear Michael,

I can understand in using a 48 hour incubation for a rapid microbial test method in conducting a sterility test in comparison to a 14-day incubation period to ensure recovery of stressed microorganisms.

Because you are saying that a 48-hour incubation is required to recover stresses microorganisms, are you saying that the 24-hour incubation time in USP Chapter 62 is now incorrect?

For many companies that are using rapid microbial test methods for non- sterile product formulations, they are using a 24-hour incubation period for both bacterial and mild detection with no microbial contamination issues in the marketplace as a release test.

Regards,
Don

Donald J. English Microbiological Quality Consulting LLC
Florham Park, New Jersey 07932

Sent from my iPhone

> On Sep 30, 2019, at 6:06 PM, "[log in to unmask]" <[log in to unmask] wrote:
> 
> 24 hours is not enough time for incubation prior to ATP or CO2 detection, especially for stressed organisms. 48 hours may work for a bioburden assay but certainly not for a sterility test. Michael
> 
>> On Sep 30, 2019, at 1:24 PM, Donald English <[log in to unmask]> wrote:
>> 
>> Hi Jeanne,
>> 
>> Thank you for your reply.  Because of the Eurofins data, I suspected that all rapid methods could detect both of the slow growers of Burkholderia cepacia complex with a 48 hour incubation period.  Your reply confirmed my theory that they would be detected at 48hours, but I still wonder whether  if ATP bioluminescence or Carbon dioxide detection could detect their presence in a test sample with a 24 hour incubation period by metabolism because cells are not detected for these 2 species until after a 48-hour incubation period.  When it comes to rapid  microbial test methods, most companies prefer a 24 hour incubation period instead of 48 hours. But, it is still better detect microorganisms in a test sample at 48-hours than at 5 to 7 days.
>> 
>> Regards,
>> Don
>> 
>> Donald J. English Microbiological Quality Consulting LLC
>> Florham Park, New Jersey 07932
>> 
>> 
>> 
>> Sent from my iPhone
>> 
>>> On Sep 30, 2019, at 11:04 AM, Jeanne Moldenhauer <[log in to unmask]> wrote:
>>> 
>>> Don
>>> 
>>> One of my clients, using a Celsis method was able to detect the two slow
>>> growers.  They held the samples for 48 hrs and then did the rapid test
>>> method.  FYI, they were also required as part of the validation to show
>>> that they could recover injured forms of these organisms.  These
>>> requirements were tied to a Warning Letter.
>>> 
>>> Jeanne
>>> 
>>> On Mon, Sep 30, 2019 at 9:40 AM Donald English <[log in to unmask]>
>>> wrote:
>>> 
>>>> Dear all,
>>>> 
>>>> In the past, Burkholderia cepacia ATCC 25416 or any other Burkholderia
>>>> species was not routinely used by most companies in validating a
>>>> traditional microbial limit test for an aqueous products formulation.
>>>> 
>>>> However, this situation will be changing shortly in USP Chapter 60 becoming
>>>> effective on December 1, 2019.  According to this chapter, the following
>>>> Burkholderia cepacia complex organisms will need to be used to conduct
>>>> growth promotion and suitability testing of aqueous product formulations:
>>>> Burkholderia cepacia ATCC 25416, Burkholderia cenocepacia ATCC BAA-245 and
>>>> Burkholderia multivorans ATCC BAA-247.
>>>> 
>>>> If a company is using a rapid microbial test method for Quality Control
>>>> release testing of an aqueous product, I suspect that Burkholderia was not
>>>> even used as one of the test organisms in validating the rapid microbial
>>>> test method for that test sample.
>>>> 
>>>> With USP Chapter 60 becoming effective, it looks like that companies will
>>>> now need to include the above identified Burkholderia cepacia complex
>>>> organisms as test microorganisms for validating their rapid methods for
>>>> aqueous product formulations to demonstrate equivalence to the USP.
>>>> 
>>>> In the Eurofins webinar presentation on USP Chapter 60, they had indicated
>>>> that Burkholderia cenocepacia ATCC BAA-245 and Burkholderia multivorans
>>>> ATCC BAA-247 could not be detected in a pre-enrichment sample until after a
>>>> 48-hour incubation period.
>>>> 
>>>> In most rapid microbial test methods, a 24-hour enrichment step of a test
>>>> sample is used.  Because Burkholderia cenocepacia ATCC BAA-245 and
>>>> Burkholderia multivorans ATCC BAA-247 are slow growers and could not be
>>>> detected in a traditional pre-enrichment as shown in the Eurofins data, I
>>>> have a question as to whether a rapid microbial test method would even
>>>> detect the presence of these 2 organisms in which a 24-hour incubation
>>>> period is used for enrichment.
>>>> 
>>>> I have a theory.  If your rapid microbial test method is based upon
>>>> metabolism (e.g. ATP Bioluminescence or Carbon dioxide detection), I
>>>> suspect that you could detect the presence of Burkholderia cenocepacia ATCC
>>>> BAA-245 and Burkholderia multivorans ATCC BAA-247 in a test sample just
>>>> like Aspergillus brasiliensis can be detected in a rapid microbial test
>>>> method from metabolism in which mycelium or spores are not available for
>>>> detection by using a 24-hour incubation period.  If you are using a rapid
>>>> microbial test method such as Flow Cytometry, I suspect that you may not
>>>> detect the presence of Burkholderia cenocepacia ATCC BAA-245 or
>>>> Burkholderia multivorans ATCC BAA-247 in a 24-hour enrichment sample due to
>>>> the lack of cells as shown by the Eurofins data when the pre-enrichment
>>>> broth was sub-cultured.
>>>> 
>>>> I wondering as to whether people have been able to detect the presence of
>>>> Burkholderia cenocepacia and/or Burkholderia multivorans in a test sample
>>>> by using a rapid microbial test method such as ATP Bioluminescence or
>>>> Carbon dioxide detection and not by Flow Cytometry in which a 24-hour
>>>> enrichment period is used.
>>>> 
>>>> Don
>>>> 
>>>> Donald J. English Microbiological Quality Consulting LLC
>>>> 
>>>> Florham Park, New Jersey 07932
>>>> 
>>>> ------------------
>>>> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
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>>>> 
>>>> 
>>>> Science Advisory Board https://www.scienceboard.net/
>>>> 
>>>> Steris - http://www.sterislifesciences.com/
>>>> 
>>>> Charles River Laboratories - http://www.criver.com/
>>>> 
>>>> Veltek Associates, Inc - http://www.sterile.com
>>>> 
>>>> Microbiologics, Inc. - http://www.microbiologics.com
>>>> 
>>>> BD Industrial Media - http://www.bd.com/ds/
>>>> 
>>>> Boston Analytical http://www.bostonanalytical.com/
>>>> 
>>>> Associates of Cape Cod, Inc. - http://www.acciusa.com/
>>>> 
>>>> 
>>>> =================================
>>>> The nature of this service is to provide a medium for communication.  The
>>>> specific statements and endorsements of individuals participating in the
>>>> discussions are not necessarily those of The Microbiology Network, Inc.,
>>>> the PMF, or the sponsors of the list.
>>>> 
>>> 
>>> ------------------
>>> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
>>> The Microbiology Network (http://microbiologynetwork.com) and supported by
>>> our sponsors as a service to the scientific community.
>>> 
>>> Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
>>> If your company would be interested in sponsoring this community, please contact [log in to unmask]
>>> 
>>> 
>>> 
>>> Science Advisory Board https://www.scienceboard.net/
>>> 
>>> Steris - http://www.sterislifesciences.com/
>>> 
>>> Charles River Laboratories - http://www.criver.com/
>>> 
>>> Veltek Associates, Inc - http://www.sterile.com
>>> 
>>> Microbiologics, Inc. - http://www.microbiologics.com
>>> 
>>> BD Industrial Media - http://www.bd.com/ds/
>>> 
>>> Boston Analytical http://www.bostonanalytical.com/
>>> 
>>> Associates of Cape Cod, Inc. - http://www.acciusa.com/
>>> 
>>> 
>>> =================================
>>> The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.
>> 
>> ------------------
>> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
>> The Microbiology Network (http://microbiologynetwork.com) and supported by
>> our sponsors as a service to the scientific community.
>> 
>> Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
>> If your company would be interested in sponsoring this community, please contact [log in to unmask]
>> 
>> 
>> 
>> Science Advisory Board https://www.scienceboard.net/
>> 
>> Steris - http://www.sterislifesciences.com/
>> 
>> Charles River Laboratories - http://www.criver.com/
>> 
>> Veltek Associates, Inc - http://www.sterile.com
>> 
>> Microbiologics, Inc. - http://www.microbiologics.com
>> 
>> BD Industrial Media - http://www.bd.com/ds/
>> 
>> Boston Analytical http://www.bostonanalytical.com/
>> 
>> Associates of Cape Cod, Inc. - http://www.acciusa.com/
>> 
>> 
>> =================================
>> The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.
> 
> ------------------
> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
> The Microbiology Network (http://microbiologynetwork.com) and supported by
> our sponsors as a service to the scientific community.
> 
> Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
> If your company would be interested in sponsoring this community, please contact [log in to unmask]
> 
> 
> 
> Science Advisory Board https://www.scienceboard.net/
> 
> Steris - http://www.sterislifesciences.com/
> 
> Charles River Laboratories - http://www.criver.com/
> 
> Veltek Associates, Inc - http://www.sterile.com
> 
> Microbiologics, Inc. - http://www.microbiologics.com
> 
> BD Industrial Media - http://www.bd.com/ds/
> 
> Boston Analytical http://www.bostonanalytical.com/
> 
> Associates of Cape Cod, Inc. - http://www.acciusa.com/
> 
> 
> =================================
> The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



Science Advisory Board https://www.scienceboard.net/

Steris - http://www.sterislifesciences.com/

Charles River Laboratories - http://www.criver.com/

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

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