PMFLIST Archives

June 2020


Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Marcie Twedell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Sat, 13 Jun 2020 17:41:34 +0000
text/plain (38 lines)

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.


Get Outlook for Android<>

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 -

Charles River Laboratories -

Veltek Associates, Inc -

Microbiologics, Inc. -

BD Industrial Media -

Associates of Cape Cod, Inc. -

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.