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November 1998

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The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Wed, 25 Nov 1998 08:48:24 EST
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     Dear Greg:

     You are correct in indicating that there is no USP referee methods for
     media -fills.However, in the 8th Supplement of USP 23 is an
     information chapter <1116> Microbiological Evaluation of clean Rooms
     and Other Controlled Environments that discusses under a section
     titled "Operational Evaluation of the Microbiological Status of
     Aseptically Filled Products in Clean Rooms and Other Controlled
     Environments"(p.4430) the issue of media fill, and that quote the 1987
     FDA Guidelines on Sterile Drug Products Produced by Aseptic
     Processing. We indicate that the filled containers are incubated at
     22.5 (+ or -) 2.5 C OR at 32.5(+ or -)2.5 C, for a minimum of 14 days.
     If two temperatures are used for incubation then they should be
     incubated for at least 7 days at each temperature.



            Roger Dabbah,USP

            [log in to unmask]
______________________________ Reply Separator _________________________________
Subject: Re: [PMFLIST] Media Fill Incubation Temperature
Author:  The Pharmaceutical Microbiology Mail List <[log in to unmask]> at
internet-mail
Date:    11/25/98 7:52 AM


I don't believe that there currently are any USP methods for media fill
incubation; thus it would be difficult to circumvent them.  It seems
that even quite recent espousements from the Agency recognize that this
is a rather undefined area, with no firm regulatory guidance as of yet.
I am also unsure as to how one validation exercise, if properly
documented and performed, could be viewed as "noncompliant with already
validated methods" - if this is correct, it seems that improvements in
an established ("validated") system would thus be precluded, since any
attempts to validate such an improvement would be "noncompliant with
(the) already validated method".  I do think, however, that the use of
stock bugs (C. alb and A. niger) is suspect - the theoretical argument
can be made that they are much more hardy than potential environmental
inhabitants, and that's a difficult argument to handle.  Better evidence
would be the inclusion (successfully) of isolates from the local filling
environment.

Greg Carrier
[log in to unmask]

-----Original Message-----
From: Davin C. Enigl [mailto:[log in to unmask]]
Sent: Tuesday, November 24, 1998 10:17 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Media Fill Incubation Temperature


In a message dated 11/23/1998 4:17:01 PM Pacific Standard Time,
[log in to unmask] writes:

<< How do you think FDA microbiologists would handle validation data
(using C.
 albicans and A. niger) that showed adequate recovery with the 30-35C
 incubation first followed by 20-25C? >>

I my opinion, they (and I would agree with them) would say:  You got
lucky
this time, but in general, you are violating standard methods procedures
and
are therefore noncompliant with already validated methods.  It sounds to
me
like someone is trying to circumvent the method in order to save time
and
money -- to heck with the USP method validations and standard methods
protocols.

Davin C. Enigl,
Regulatory Compliance Microbiologist
[log in to unmask]


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