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October 1999

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Subject:
From:
Antti Mikkola <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Fri, 22 Oct 1999 11:59:32 +0200
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Dear members of the forum

I have two questions about the correct way of storing microbial cultures
at low temperatures.

USP 24 (under <51> Antimicrobial Effectiveness Testing, Test
Organisms) defines that the vials, containing glycerol-protected cell
suspensions must be stored in the following way: "Store the vials in
liquid nitrogen or in a mechanical freezer at no more than -50 C."

What is the rationale behind the limit -50 C?

Would it be acceptable to store the cultures at temperatures less than
-50 C, provided that it can be shown that viability or other characteristics
are not adversely affected during the maximum storage time?


Many thanks in advance for your help

Antti Mikkola
Orion Pharma
Finland


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