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April 2017

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Subject:
From:
Muhammod Saiyem <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Sat, 22 Apr 2017 10:14:29 +0600
Content-Type:
text/plain
Parts/Attachments:
text/plain (211 lines)
Dear members
In our new sterile manufacturing area, we selected locations for
environmental monitoring based risk assessment before initial HVAC PQ
start. Now, after one year, we want to reduce the no. of sampling locations
for routine EM based on proper justifications. We have planned to justify
this considering the followings-

1. Previous EM data of HVAC PQ
2. Previous EM trend of routine EM.
3. Type of area, activity & impact on product.

I would like to know is there any statistical approach for evaluating the
previous EM data & trend to justify the reduction of sampling locations for
routine EM?

Any references & further suggestions?

Please let me know.

Thanks
Saiyem
Square Pharmaceutical Ltd.
www.squarepharma.com.bd

On Apr 22, 2017 1:46 AM, "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 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.

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