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October 2009

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Subject:
From:
"Geis, Phil" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 9 Oct 2009 13:01:07 -0400
Content-Type:
text/plain
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text/plain (143 lines)
Doubt the pH is low enough to be prohibitive to contaminants (you'd need
~ 2).

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of
[log in to unmask]
Sent: Friday, October 09, 2009 5:29 AM
To: [log in to unmask]
Subject: [PMFLIST] pH as preservative agent?

Dear Forum,
I have a question concerning multidose product. Must a multidose 
injectable product have antimicrobial agents in its formulation or is it

sufficient that the formulation as it is pass the Criteria for 
Preservative Efficay Test?  Can the low pH be considered as
"preservative 
agent "in multidose product? 
Is it possible to submit an injectable product  as multidose even if it 
does not contain preservative agents (cresol, phenol,etc..) in its 
formulation but only low pH ? 

Please note that the formulation pass the USP criteria for Preservative 
Efficacy Test.  What could be FDA point of view?

My doubt is if could be correct to add to Preservative Efficacy Test
also 
low pH tolerant bacteria (e.g. lactobacillus, enterococcus or 
streptococcus) to have data supporting submission of the product as 
multidose.

Waiting for your precious feedback

Best regards
Paola



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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

American Type Culture Collection - http://www.atcc.org

Applied Biosystems, MicroSeq Microbial ID System - http://www.microseq.com/

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

EMD Chemicals - http://www.emdchemicals.com

MicroBioLogics, Inc. - http://www.microbiologics.com

Millipore - http://www.millipore.com

MODA Technology Partners - http://www.modatp.com

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

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