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October 2019

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Subject:
From:
sam taba <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 2 Oct 2019 08:33:39 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (218 lines)
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
Sam.T

On Tue, Sep 24, 2019 at 2:56 PM Jeanne Moldenhauer <
[log in to unmask]> wrote:

> Most of the contract laboratories using RMMs for sterility testing utilize
> the BacT/Alert or the BacTec.  Some have claimed a 5 day sterility test.
>
> The issue is whether the contract laboratory has adequately validated the
> system (see USP <1223> and PDA's Technical Report 33 (Revised) to assess
> the quality of the validation.
>
> Depending upon the system used and the method of validation, some have
> claimed shorter incubation times.
>
> An additional concern with the use of contract laboratories, is that many
> of these systems test a smaller volume of sample than that in USP <71>,
> There also needs to be sufficient validation data that shows that the
> smaller sample size is not inferior to the sample size used in USP <71>.
>
> Several compounding pharmacies have been cited by FDA on the incubation
> time and smaller sample size validation being inadequate.
>
> Jeanne Moldenhauer
>
>
> On Mon, Sep 23, 2019 at 6:01 PM Dr. Michael J. Miller <
> [log in to unmask]> wrote:
>
> > Not enough info to provide an answer. Need the following:
> >
> >
> > What is the rapid method?
> > What was performed in the lab’s PQ validation? LOD, equivalency,
> > specificity, etc.
> > Have they performed any method suitability studies?
> > Will your client’s samples be compatible?
> >
> >
> > Please advise accordingly or contact me separately.
> >
> >
> >
> > Regards, Michael
> >
> >
> >
> > Michael J. Miller, Ph.D.
> >
> > President
> > Microbiology Consultants, LLC
> > 19009 St. Laurent Drive, Lutz, FL 33558
> > phone: 727-437-2743 (RAPID-RAPID)
> > email: [log in to unmask]
> > web: http://microbiologyconsultants.com
> > linkedIn: http://www.linkedin.com/in/drmichaelmiller
> >
> > http://rapidmicromethods.com – advancing the science and implementation
> > of rapid microbiological methods.
> >
> >
> >
> >
> >
> >
> >
> > 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: Monday, September 23, 2019 at 4:08 PM
> > To: <[log in to unmask]>
> > Subject: [PMFLIST] Sterility USP 71 & USP 797
> >
> >
> >
> > Dear Forum, an external laboratory offers ( to one of our clients)that
> the
> >
> > sterility test  with rapid method ( only 5 days incubation compared to 14
> >
> > days recommended by above methods) . do you think this is acceptable?
> why?
> >
> > Thank you for your valued input.
> >
> > Regards
> >
> > Sam.T
> >
> >
> >
> >
> >
> >
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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
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>
> ------------------
> 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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