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October 2019

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Subject:
From:
"Krieger, Richard" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 9 Oct 2019 14:30:34 +0000
Content-Type:
text/plain
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Hello Claudia:

If it is a buffer solution the CoA is usually acceptable. As far as a growth media you should have an incoming process to QC your media for growth. If used in a test procedure, the parameters of the testing media and organisms used for recovery should be validated to suite that test method. You may refer to USP 1117 Microbiological Best Laboratory Practices for some guidance on growth promotions. 

My suggestion is do growth promotions.

Regards

Rick

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Claudia Lawson
Sent: Tuesday, October 8, 2019 2:09 PM
To: [log in to unmask]
Subject: [PMFLIST] Biolumix Growth Promotion

Hello Everyone,

We’re looking into purchasing a Biolumix machine from Neogen to make our micro life a little easier. The only question I have left about it that I cannot get a straightforward answer on: Do we need to perform Growth Promotion Testing on the media vials we use in the machine?

Biolumix says that their vials are certified and that it isn’t required, but…..what would FDA have to say about that? Has anyone here ever undergone an FDA audit with the Biolumix? If so, what was their take on growth promotion?

Any information you guys have would be extremely helpful!
Thank you in advance 😊
-Claudia






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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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