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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:
Fri, 27 Mar 2020 15:02:15 -0400
Content-Type:
text/plain
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text/plain (161 lines)
Zahiruddeen,

 

If there is a shut down during incubation you have altered the validated or compendial method requirements. In this case it is unknown whether this lapse in maintaining temperature will have an impact on the recovery of organisms, especially if they are stressed. You will either have to replicate the conditions and qualify the extended incubation or simply repeat the test with new samples (if possible and if this situation was a one-time event). 

 

Michael

 

-----

 

Dear Forum,

 

Please guide me how to address Analyzed sample results (Water, Product,

GPT) observation, sample enrichment periods/incubation timings has been

increased by one day or two days due to sudden complete shut down.

And let me know for this any guideline references are available..

 

 

Regards,

Zahiruddeen

 

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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 PMF or the sponsors of the list.

 


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The PMFList is 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]



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/

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 PMF or the sponsors of the list.

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