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November 2013

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Subject:
From:
Daniel Guntle <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 6 Nov 2013 16:52:28 -0800
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Brian and Ram,

I come across this issue many times with our clients. The USP chapter <61> gives guidance for small batch sizes like yours. It specifies a sampling size of 1% of the batch if the total batch size is less the 1 Kg or Liter along with other pertinent guidance that may be relevant to your situation. 

Thank You,

Daniel Guntle 
Sr. Microbiology Manager
T: 949.951.4425 x 257 | F: 949.587.8435 
E: [log in to unmask] 

Irvine Pharmaceutical Services, Inc. 
www.irvinepharma.com|www.avriobiopharma.com 


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Sivasailam Ramasubramanian
Sent: Tuesday, November 05, 2013 4:16 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] salmonella

Hi Brian,

I have one more request on this, if API batch size itself 30 - 40g, in this case I cannot use 10g for Salmonella. 

Please suggest.

Thanks and Regards
Ram S

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Brian Matthews
Sent: Saturday, November 02, 2013 2:42 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] salmonella

Comments below in CAPITALS for clarity.

Regards,

Brian Matthews.



>     during MLT analysis most cases we use to take 10g for salmonella.
> in some cases we use to do analysis with 0.1g or 1g . in this case how 
> to interpret result to 10g?. what about recovery of least quantity 
> sample? . whether it will give correct result or false result when 
> your taking least quantity?`
>

IF YOU USE LESS THAN A 10 G SAMPLE THEN YOU HAVE NO WAY OF PREDICTING WHAT THE RESULT WOULD BE ON A FULL-SIZED SAMPLE.  MICROORGANISMS ARE NOT USUALLY EVENLY DISTRIBUTED IN BULK SAMPLES.

>
>
>    As per usp <1116> sampling  to be done each operating shift. how 
> many hours for each operating shift?.
>

THAT WILL DEPEND ON HOW YOU OPERATE YOUR PLANT.  HOW OFTEN DO YOU HAVE A  CHANGE OF PERSONNEL?

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The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from The Microbiology Network (http://microbiologynetwork.com) and supported by our sponsors 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.


Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics

Accugenix - http://www.accugenix.com

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

ATS Labs - http://www.ats-labs.com

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

Biolog - http://www.biolog.com

EMD Millipore -  http://www.emdmillipore.com/biomonitoring

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

Microtest Laboratories, Inc. - http://www.microtestlabs.com

Pall - http://www.pall.com

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

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

Steris - http://www.sterislifesciences.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://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors 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.


Life Technologies - http://www.lifetechnologies.com/PharmaAnalytics

Accugenix - http://www.accugenix.com

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

ATS Labs - http://www.ats-labs.com

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

Biolog - http://www.biolog.com

EMD Millipore -  http://www.emdmillipore.com/biomonitoring

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

Microtest Laboratories, Inc. - http://www.microtestlabs.com

Pall - http://www.pall.com

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

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

Steris - http://www.sterislifesciences.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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