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Subject:
From:
Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 15 Jun 2020 13:18:04 -0400
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Dear Marcie,

Gram stains on bacterial isolates should be performed on cultures that are 18 to 24 hours in age.  If a culture is older than 30 hours in age, I have seen errors in how the stains of the Gram stain are taken up by cells that could lead to a mistaken identification for certain bacterial species. I m talking about what is Gram-positive and what is Grsm-negative rather than cell morphology.

In most introductory courses in Microbiology that I had taught, I always had recommended that. gram stain be performed on a bacterial culture that are 18 to 24 hours in age.  In addition,   most Microbiology textbooks recommend that Gram staining be performed on bacterial cultures that are 18 to 24 hours in age.  If people are performing Gram staining on bacterial cultures that are 48 hours in age, it is indication that the laboratory is not following proper microbiological techniques in conducting microbial testing of samples from my perspective which could result in a big regulatory issue.

Don

Donald J. English Microbiological Quality Consulting LLC
Florham Park, New Jersey 07932


Sent from my iPhone

> On Jun 15, 2020, at 10:33 AM, Marcie Twedell <[log in to unmask]> wrote:
> 
> ´╗┐All,
> 
> I am looking for guidance regarding the required time frame  for performing gram staining post test completion.  ISO 11737 states that bioburden characterization is to be performed; however, it does not provide a timing requirement for the completion of the characterization.
> 
> I know that gram staining should be performed on young cells and I have seen documents from various companies that require staining anywhere from 18 to 48 hours.  Are there any standards that specify the timing or provide guidance (perhaps a TIR)?
> 
> For those of you that are or have been regulatory authority auditors, what are your expectations?
> 
> Thank you for your consideration of this communication and any answers you provide.
> 
> -MT
> 
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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 - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

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/


=================================
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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