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October 2019

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Subject:
From:
"Dr. Michael J. Miller" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 9 Oct 2019 10:34:43 -0400
Content-Type:
multipart/related
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YES! You should perform GP and sterility verification on each incoming lot of vials. This is no different than the testing you would perform for incoming conventional media.

 

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 Claudia Lawson <[log in to unmask]>
Reply-To: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date: Wednesday, October 9, 2019 at 10:09 AM
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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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.

 


------------------
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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