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December 2002

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Subject:
From:
Scott Sutton <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Thu, 12 Dec 2002 01:47:57 GMT
Content-Type:
text/plain
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With respect, this is not correct.  Any step that involves growth was
meant to be included in counting of transfers or passages.  If all you
are doing is re-hydrating lyo cultures in saline, that is not a
passage.  If you are suspending in a volume of growth media and then
incubating under conditions supportive of growth, that is a passage.  

Does anyone have a sugggestion about how this section could be
rewritten to make this more clear?

Scott Sutton

On Wed, 11 Dec 2002 10:45:12 -0600, you wrote:

>Jeanne,
>
>I forwarded your question on to Forest Reichal at MicroBioLogics.  They are a manufacturer of over 600 Reference Stock Cultures, most of which they derive direct from ATCC cultures.  Below is his view on definition of "passage":
>
><<The revival of the original ATCC culture, hydrating the lyophilized pellet and establishing growth is not considered a transfer or passage, see the statement below that you have taken from the USP.  The key factor as with the frozen culture is that in order to establish normal metabolic function a passage from the primary growth must be performed.  The transfer of existing growth to fresh medium is the definition of a passage.   
>
>Best regards,
>
>Forest D. Reichel
>Industrial Product Manager
>Marketing Manager 
>MicroBioLogics
>[log in to unmask]>>
>
>We represent their company in the Pharmaceutical and many international markets, so please feel free to contact me if you have any questions or comments.
>
>Sincerely
>
>Chris R. Dwyer
>Raven Biological Laboratories
>www.ravenlabs.com
>8607 Park Drive
>Omaha, NE 68127 
>USA
>  ----- Original Message ----- 
>  From: Jeanne Wilcox 
>  To: [log in to unmask] 
>  Sent: Tuesday, December 10, 2002 11:51 AM
>  Subject: [PMFLIST] Culture Passage Guidelines
>
>
>
>  We're having difficulty agreeing on what "established" means.   
>
>  The USP states: 
>  The viable microorganisms used in the test must not be more than
>  five passages removed from the original ATCC culture. For purposes of the test, one passage is defined as 
>  the transfer of organisms from an established culture to fresh medium. All transfers are counted. In the case 
>  of organisms maintained by seed lot techniques, each cycle of freezing, thawing, and revival in fresh medium
>  is taken as one transfer. 
>
>  The dictionary defines establish as:  "to introduce and cause to grow and multiply".   
>
>  Therefore, an actively growing plate or tube would be an established culture.  Can you argue that an ATCC lyo is not "established", but your first inoculation of a broth/agar medium is? 
>  If that is true, than your resuspension and inoculation of the contents of an ATCC vial would not be a passage.  Correct? 
>  What about frozen and then thawed vials?  Established or not? 
>
>  Opinions? 
>
>  Jeanne Wilcox
>
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