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May 2018

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Subject:
From:
"Stewart, Jonathan" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 1 May 2018 17:13:54 +0000
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Brad,

USP Chapter <61> requires that negative controls are performed and that failed negative controls are investigated, therefore negative controls are required. Negative controls are critical to microbial data deviation investigations and cheap insurance against false positives. Even if they weren't requirement, running negative controls is in your best interest, especially when your bioburden test produces unexpected growth. Ruling out media contamination as a contributing factor is difficult without all test data available representing each media utilized under the same test conditions. If you are using a rinse media such as Fluid A, filtered a portion of the rinse media, placed the filter on an agar plate, and neither the rinse filter nor agar around the filter show growth, then both the agar plate and rinse media negative controls pass. Alternately, having a separate negative control plate for both the agar and the rinse fluid gives greater granularity and can be important if you have ever experienced negative control failures implicating contamination of agar plates or rinse fluid. You could go one step further and place an unused filter on an agar plate to show that the filter alone did not contaminate the test. If you inadvertently run a bioburden or other microbiological test without performing the negative control(s) you will need to write an investigation as to why the written procedure was not followed. I hope this helps.

Best,
Jon

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Bradford Booth
Sent: Monday, April 30, 2018 2:38 AM
To: [log in to unmask]
Subject: [PMFLIST] Negative Control requirements

 

Hello all,

 

In Micro testing, sometimes more than one lot of a particular media is used (e.g. for a bioburden test, 5 TSA plates from Lot A, and 3 TSA plates from Lot B).  While this is not ideal, sometimes it is required if stocks are low, etc.

 

In this case, my experience is that a negative control is required for each lot of media.

 

 

Does anyone know if there is any actual regulatory requirement for this, or is it just a good lab practice?

 

 

Thanks for any feedback,

 

-Brad

 

 


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