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October 2005

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From:
Cecie Jiang <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 25 Oct 2005 10:53:23 -0400
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Hi, Dr. Farrington,

I agree with you that the tablet coating solution could have problem
within 24 hours. Could you have microbial specifications for your
coating solutions? If you do, what are the limits?  

I know no matter how high the counts of the coating solutions are, the
total counts of the finished tablets will always be <1 cfu/g. I also
understand P. aeruginosa can produce endotoxins and exotoxins. If we
only test finished products without testing the coating solution, could
the toxin be a problem for the tablets? Thank you,

Cecie   

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of Joseph Kirby
Farrington
Sent: Monday, October 24, 2005 12:11 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] Microbial stability of liquid coating for tablets

All,

  Tablet coating solutions can be problematic within 24 hours. In
particular sugar coating solutions sometimes called A!, etc. You need to
be looking for osmophilic organisms like Y & M. Even if these are made
hot, the containers, spills, etc can be real problems real fast.


Kirby

J. Kirby Farrington, Ph.D. (RM/SM)
Research Advisor-Microbiology and Sterility Assurance Eli Lilly
Indianapolis  46285
Lilly LTC   Mail Stop 5546
317-651-9620  Beep.256-2840 cell 317-430-6548



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10/20/2005 01:28 PM
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Re: [PMFLIST] Microbial stability of liquid coating for tablets






Does coating solution composition give techncial reason to believe in a
week's "stability"?  Wasn't sure from your inquiry - are you carrying
out challenge testing?





Michelle Swenson <[log in to unmask]> Sent by: The Pharmaceutical
Microbiology Forum Email List <[log in to unmask]>
10/20/2005 10:29 AM
Please respond to The Pharmaceutical Microbiology Forum Email List

 
        To:     [log in to unmask]
        cc: 
        Subject:        [PMFLIST] Microbial stability of liquid coating 
for tablets


I have been browsing the archives for some time now, but this is my
first post.  I work in a non-sterile plant, where we make mostly tablets
and capsules.  For one of our tablets, the coating solution is prepared
on the 


day of use and the remaining solution is thrown away at the end of the
day.  I have been asked to do a study and validate the microbial
stability 


of the prepared coating solution so it can be held and used for a longer

period of time
(they are trying for a week).

Does anyone have any recommendations on how to go about doing this?  I
am 
setting up prep tests and then taking samples the day of the preparation

and each day thereafter for 5-7 days.  Should I be testing only TAPC/M&Y

or full MLTs testing?  Would this yield enough information to back up
any 
decisions, as we would be testing only one prepared lot?  I'm wondering
if 


that is enough baseline info.  Would we need to continue testing after
the 


procedure is in place?

Any comments or suggestions you can provide on how to run the study and 
justify the change in procedure would be terrific!

Regards,

Michelle  Swenson
Microbiologist
IVAX Pharmaceuticals
Miami, FL
305-575-6621


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------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) 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.

Accugenix - http://www.accugenix.com/
ATS Laboratories - http://www.ats-labs.com
Biolog - http://www.biolog.com
Biomerieux - http://industry.biomerieux-usa.com/
Dupont Qualicon - http://www.qualicon.com
EMSL Analytical, Inc. - http://www.emsl.com
Genomic Profiling Systems, Inc. - http://www.genprosys.com
Microcheck Inc,  Microbial Analysis Laboratory -
http://www.microcheck.com
MicroTest World Class Services - http://www.microtestlabs.com/
MIDI, Inc. - http://www.midi-inc.com/
Millipore - http://www.millipore.com/
NovaTek International - http://www.ntint.com
Raven Biological Labs - http://www.ravenlabs.com
Veltek Associates, Inc - http://www.sterile.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 Microbiology Network, Inc.,

the PMF, or the sponsors of the list.



------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) 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.

Accugenix - http://www.accugenix.com/
ATS Laboratories - http://www.ats-labs.com
Biolog - http://www.biolog.com
Biomerieux - http://industry.biomerieux-usa.com/
Dupont Qualicon - http://www.qualicon.com
EMSL Analytical, Inc. - http://www.emsl.com
Genomic Profiling Systems, Inc. - http://www.genprosys.com
Microcheck Inc,  Microbial Analysis Laboratory -
http://www.microcheck.com
MicroTest World Class Services - http://www.microtestlabs.com/
MIDI, Inc. - http://www.midi-inc.com/
Millipore - http://www.millipore.com/
NovaTek International - http://www.ntint.com
Raven Biological Labs - http://www.ravenlabs.com
Veltek Associates, Inc - http://www.sterile.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 Microbiology Network,
Inc., the PMF, or the sponsors of the list.

------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) 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.

Accugenix - http://www.accugenix.com/
ATS Laboratories - http://www.ats-labs.com
Biolog - http://www.biolog.com
Biomerieux - http://industry.biomerieux-usa.com/
Dupont Qualicon - http://www.qualicon.com
EMSL Analytical, Inc. - http://www.emsl.com
Genomic Profiling Systems, Inc. - http://www.genprosys.com
Microcheck Inc,  Microbial Analysis Laboratory - http://www.microcheck.com
MicroTest World Class Services - http://www.microtestlabs.com/
MIDI, Inc. - http://www.midi-inc.com/
Millipore - http://www.millipore.com/
NovaTek International - http://www.ntint.com
Raven Biological Labs - http://www.ravenlabs.com
Veltek Associates, Inc - http://www.sterile.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 Microbiology Network, Inc., the PMF, or the sponsors of the list.

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