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November 2019

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Subject:
From:
Dale Kelley <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 12 Nov 2019 14:54:50 +0000
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Reuven,
Yes, you should have a negative control.  The negative control should be based on the testing technique and mimic as near a practical the manner in which the test is performed.  You need to consider not making it more risky than the actual test.
Based on your test description I would recommend either: perform a mock dilution and transfer to media, or transfer of Fluid A direct to media.

Hope this helps,


Dale Kelley
Director
Protocol Link, Inc.
175 E. Hawthorn Parkway, Suite 210
Vernon Hills, IL 60061 USA
office +1-847-549-0390
www.protocollink.com





-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Reuven Baum
Sent: Sunday, November 10, 2019 1:27 PM
To: [log in to unmask]
Subject: [PMFLIST] sterility test control

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 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/


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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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