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October 2019

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Subject:
From:
Jeanne Moldenhauer <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 3 Oct 2019 10:14:42 -0500
Content-Type:
text/plain
Parts/Attachments:
text/plain (286 lines)
Sam

In many ways this is an easier system to test.  There is good guidance in
USP <1223> and PDA's Technical Report No. 33.  In addition to the testing
in these two documents, you will need to generate data to show that the
reduced sample size is equivalent or non-inferior to the existing method.
Many compounding sites have used this product or the BacT/Alert for
sterility testing.  Several have been cited for not having data to support
the reduced sample size.

Another concern for you is how to cover the range of products you make.
For example, will you qualify the instrument with a solution like saline,
which is not bacteriostatic and then do method suitability over all your
products and/or do you have a matrix to identify which products can be
tested as representative of a series of products.

Jeanne Moldenhauer
Excellent Pharma Consulting
847 414 4828

On Wed, Oct 2, 2019 at 8:57 PM sam taba <[log in to unmask]> wrote:

> 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
> > specific statements and endorsements of individuals participating in the
> > discussions are not necessarily those of The Microbiology Network, Inc.,
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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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