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May 2011

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Subject:
From:
Raj kishore <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Sun, 1 May 2011 06:32:43 -0000
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Dear fraser,
The limits are as per USP  chapter. 

dear veronica,

i would like to know the oral liquid is an aqeuous or Non-aqeuous preparation.

most of the times bacillus species will recover on the SDA due to non-selectivity of the media. You can add chloramphenicol 50 mg into one litre SDA preparation prior to sterilisation.

Then you conduct one more analysis and observe the counts. Most probably your problem will get resolved. If not you go for a identification to confrim the source of contamination.

As a microbiologist you have to initiate investigation if this type of observation occur.

Regards
Raj Kishore  


On Sat, 30 Apr 2011 01:23:44 +0530  wrote
>Veronica......why is your limits 100cfu/g and 10cfu/g? USP limits for non-sterile oral liquids are 1000 cfu/g for TAPC and 100cfu/g for TYMC. Do you have specific requirements to have such tight limits? 



If you add an antibiotic to the SDA you probably will not have the problem of recovering extraneous organisms in the SDA. 



Also, if you stay with your current limits and recovery of organisms fails the specification, unless you find the 'smoking gun' for the failure, you should not release the batch............Lou Fraser



-----Original Message-----

From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Veronica Percovich

Sent: Tuesday, April 26, 2011 8:07 AM

To: [log in to unmask]

Subject: [?? Probable Spam] [PMFLIST] RV: Bacterias in Sabouraud Dextrose Agar

Importance: High



Dear colleagues,



I would really appreciate very much if you share your opinion about this issue.





Regards,



________________________________

Q.F. Verónica Percovich

Supervisora Sector Microbiología - LCC

Laboratorios Celsius S.A.

Avda. Joaquín Suárez 3593 - Montevideo - Uruguay



Tel 2336 54 46 int 179



www.celsius.com.uy



 De: Veronica Percovich

Enviado el: Martes, 01 de Marzo de 2011 03:58

Para: [log in to unmask]

Asunto: Bacterias in Sabouraud Dextrose Agar

Importancia: Alta





Dear forum members,



I'm in the following situation and I need your opinion or advice: I'm analyzing a liquid product (is a new product for oral administration wich is still under development) with these specifications: 100 cfu/g and 10 cfu/g for bacterias and yeasts and moulds respectively, and I had these counts: 45 cfu/g and 140 cfu/g. The microorganisms identified were Bacillus sp. Then, the product is out of specification because USP tell us that we have to inform bacterias as yeasts and moulds if they were recuperated in the y and m media.

Furthermore, I repeated the counts of other bottles and the results were always >10 cfu/g and < 100 cfu/g. I could have used a Sabouraud Dextrose Agar with antibiotics and probably the count were between limits. Then, in this case and if the sales team wants to sell the product, what would you do?

I really appreciate your opinions.

Regards,

________________________________

Q.F. Verónica Percovich

Supervisora Sector Microbiología - LCC

Laboratorios Celsius S.A.

Avda. Joaquín Suárez 3593 - Montevideo - Uruguay



Tel 2336 54 46 int 179



www.celsius.com.uy











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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



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



Biolog - http://www.biolog.com



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



Biotest - http://www.BiotestUSA.com/micro



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



Millipore - http://www.millipore.com



MODA Technology Partners: now a LONZA company http://lonza.com/moda



Pall - http://www.pall.com



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



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



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

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

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

Biolog - http://www.biolog.com

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

Biotest - http://www.BiotestUSA.com/micro

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

Millipore - http://www.millipore.com

MODA Technology Partners: now a LONZA company http://lonza.com/moda

Pall - http://www.pall.com

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

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

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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