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November 2019

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From:
Veronica Marshall <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 11 Nov 2019 19:14:30 -0500
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Hi Reuven,

The negative control should be executed in a similar fashion as the test. 
I would recommend that you perform a mock dilution of fluid A, then 
transfer the final test volume (1mL) to TSB and FTM as the negative 
controls.  This allows evaluation on your test environment, test analyst 
and dilution fluid.

Regards,


Veronica Marshall
Sr. Manager, Quality Control
Xellia Pharmaceuticals USA, LLC
200 Northfield Road
Bedford OH USA 44146 
tel +1 440-359-2205   fax +1 440 359 2465   mobile +1 440-903-7905   
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www.xellia.com 

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From:   "Reuven Baum" <[log in to unmask]>
To:     [log in to unmask]
Date:   11/11/2019 05:44 PM
Subject:        [PMFLIST] sterility test control
Sent by:        "The Pharmaceutical Microbiology Forum Email List" 
<[log in to unmask]>



I am doing a direct inoculation sterility test.
The test only contains a small volume. I expect to dilute the sample with
Fluid A  and will  transfer half the volume (total of 1 mL) to TSB and 
FTM.
The batch is so small that only one production vial is tested.
Do i need a negative control? If yes what is it?
I already performed sterility and growth test on receiving the TSB/FTM.


Reuven
QC Microbiologist
Yavne

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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/

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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/


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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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