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April 2017

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Subject:
From:
Rob E Warburton <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 25 Apr 2017 15:18:23 +0000
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Hi Saiyem ,

When we perform MF, the inoculum is added to the final rinse as Tony mentioned previously.

When performing pour plates we dilute the sample, aliquot into tubes and inoculate.  Aliquots are transferred to plates and agar added.

Rob
 

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Julie B
Sent: Sunday, April 23, 2017 11:06 AM
To: [log in to unmask]
Subject: [EXTERNAL] Re: [PMFLIST] MET method validation: recovery of microorganisms

Saiyem,

it will depend on antimicrobial activity of your product. When you to execute method suitability via pour plate method you should add microorganisms into your product matrix (i.e. product and dilutent combination), and then plate aliquotes out. It should be no different with filtration method. No, if you experiencing inhibition, then yes you can add organisms into last rinse as it was recommended previously. However, I would not jump directly to the adding organisms to the last rinse without proving that adding organisms into product matrix does not work.

Hope that helps
Julie Barlasov, MBA
[log in to unmask]

Julie Barlasov, MBA
[log in to unmask]
(908) 342-3582

On Fri, Apr 21, 2017 at 12:51 PM, moataz el gaaly <[log in to unmask]>
wrote:

> During the last third wash
>  Hope it helps
>
> Sent from my HTC
>
> ----- Reply message -----
> From: "Muhammod Saiyem" <[log in to unmask]>
> To: "[log in to unmask]" <[log in to unmask]
> MICROBIOLOGYNETWORK.COM>
> Subject: [PMFLIST] MET method validation: recovery of microorganisms
> Date: Fri, Apr 21, 2017 16:59
>
> Dear All
> During method validation of microbial enumeration test of raw 
> materials by filtration, at which stage should I add test organisms?
>
> Is it to the prepared sample solution, then filter & wash the filter 
> paper
> 3 times with suitable diluent (3*100ml)?
>
> Or at first filter the sample solution, then wash the filter paper 2 
> times and add test organisms into the filtration cup during last time 
> (3rd) washing?
>
> Please let me know your ideas.
>
> Regards
> Saiyem
> Square Pharmaceuticals Ltd.
> Bangladesh
>
>
> On Apr 20, 2017 9:09 PM, "Joan" <[log in to unmask]> wrote:
>
> Dear Forum,
>
> Does anyone have any experience of neutralizing ascorbic acid?
>
> I am trying to validate the bioburden test (pre-sterile filtration
> bioburden) for a product that contains 50mg/ml of ascorbic acid, but 
> it is inhibiting the growth of Pseudomonas aeruginosa. I have tried 
> neutralization with MgCl2 but the results have been somewhat inconclusive.
> The product cannot be diluted enough without compromising the 
> sensitivity of the test method, and I can't use membrane filtration. 
> Do you have any suggestions what would be a suitable method and/or a neutralizer?
>
> Thank you in advance
>
> Best regards,
> Joan
>
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> The nature of this service is to provide a medium for communication.  
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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.
>
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> Nelson Labs - http://www.nelsonlabs.com
>
> BD Diagnostic Systems - http://www.bd.com/ds/
>
> Boston Analytical http://www.bostonanalytical.com/
>
> MilliporeSigma  http://www.emdmillipore.com/
>
> Charles River Microbial Solutions:  Endosafe, Accugenix & Celsis   -
> www.criver.com/micro<http://www.criver.com/micro>
>
> Avista Pharma Solutions  http://www.avistapharma.com
>
> Associates of Cape Cod, Inc. - http://www.acciusa.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.
>
>
> Veltek Associates, Inc - http://www.sterile.com
>
> Microbiologics, Inc. - http://www.microbiologics.com
>
> Nelson Labs - http://www.nelsonlabs.com
>
> BD Diagnostic Systems - http://www.bd.com/ds/
>
> Boston Analytical http://www.bostonanalytical.com/
>
> MilliporeSigma  http://www.emdmillipore.com/
>
> Charles River Microbial Solutions:  Endosafe, Accugenix & Celsis   -
> www.criver.com/micro
>
> Avista Pharma Solutions  http://www.avistapharma.com
>
> Associates of Cape Cod, Inc. - http://www.acciusa.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.


Veltek Associates, Inc - http://www.sterile.com

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

Nelson Labs - http://www.nelsonlabs.com

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

Boston Analytical http://www.bostonanalytical.com/

MilliporeSigma  http://www.emdmillipore.com/

Charles River Microbial Solutions:  Endosafe, Accugenix & Celsis   - www.criver.com/micro

Avista Pharma Solutions  http://www.avistapharma.com

Associates of Cape Cod, Inc. - http://www.acciusa.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.


Veltek Associates, Inc - http://www.sterile.com

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

Nelson Labs - http://www.nelsonlabs.com

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

Boston Analytical http://www.bostonanalytical.com/

MilliporeSigma  http://www.emdmillipore.com/

Charles River Microbial Solutions:  Endosafe, Accugenix & Celsis   - www.criver.com/micro

Avista Pharma Solutions  http://www.avistapharma.com

Associates of Cape Cod, Inc. - http://www.acciusa.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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