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January 2017

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Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 12 Jan 2017 10:13:07 +0000
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Dear forum members,

Can we perform specified microorganisms test only for purified water storage tanks (or) testing of specified microorganisms for point of use once in a month instead of daily?
Pl. suggest.

Thanks & regards,
RK

-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Phanindhar T V
Sent: 11 January 2017 19:10
To: [log in to unmask]
Subject: Re: [PSDGLIST] Purified water “Specified Microorganisms test”

Dear Reddy

We can reduce the frequency of testing based on the trend data, and can reduce the detection of all specified microorganisms, pseudomonas and s.aureus must be tested. But every point o f use must be tested for specified microorganisms,

On Tue, Jan 10, 2017 at 10:29 AM, [log in to unmask] < [log in to unmask]> wrote:

> Hello Good Morning,
>
> Dear forum members please suggest
>
> Can we reduce purified water “Specified Microorganisms test” for point 
> of use & return loops, historically no specified microorganisms 
> observed in purified water system.
> Purified water storage tank contains composite water from generation 
> system & distribution (POU and return loop), is it sufficient to test 
> storage tank water for specified microorganisms?.
>
>
> Thanks & Regards,
> Ramakrishna Reddy
>
> -----Original Message-----
> From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]
> MICROBIOLOGYNETWORK.COM] On Behalf Of Siti Nurul Afizah Awang Tengah
> Sent: 10 January 2017 07:59
> To: [log in to unmask]
> Subject: [PSDGLIST] Efficacy test of 70% IPA
>
> Dear forum member,
>
>
> We have tonnes of expired IPA which was mainly used for disinfectant. 
> My question is, is it acceptable to use this expired IPA for cleaning 
> if the efficacy test is still within spec? I really appreciate if 
> anyone could share documents on the simple procedure to test for the 
> efficacy of IPA in pharmaceutical plant.
>
>
> Thank you,
>
>
> Ken
>
> SP
>
>
>
> =================================
> 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 PSDG, or the sponsors of the list.
>
> ------------------
> The PSDGList (http://microbiol.org/psdglist.htm) is operated from The 
> Microbiology Network (http://www.microbiol.org) 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.
>
>
> Avista Pharma Solutions - http://www.avistapharma.com/
>    Comprehensive testing and CMC services organization
>    Analytical and Microbiology support to early stage API and drug 
> product development and manufacturing.
>
>
> BahnsonEnvironmental Specialties - http://www.eschambers.com/
>    Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, 
> Freezers and
>    Ultra Low Storage Chambers with Complete Validation, Maintenance & 
> Calibration
>
> Cincinnati Sub-Zero - http://www.cszindustrial.com/
>     Provides a large selection of environmental chambers from 
> benchtop, reach in to walk-in
>     rooms along with chambers for freeze/thaw, temperature cycling 
> applications.
>
> =================================
> 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 PSDG, or the sponsors of the list.
>
> ------------------
> The PSDGList (http://microbiol.org/psdglist.htm) is operated from The 
> Microbiology Network (http://www.microbiol.org) 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.
>
>
> Avista Pharma Solutions - http://www.avistapharma.com/
>    Comprehensive testing and CMC services organization
>    Analytical and Microbiology support to early stage API and drug 
> product development and manufacturing.
>
>
> BahnsonEnvironmental Specialties - http://www.eschambers.com/
>    Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, 
> Freezers and
>    Ultra Low Storage Chambers with Complete Validation, Maintenance & 
> Calibration
>
> Cincinnati Sub-Zero - http://www.cszindustrial.com/
>     Provides a large selection of environmental chambers from 
> benchtop, reach in to walk-in
>     rooms along with chambers for freeze/thaw, temperature cycling 
> applications.
>

=================================
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 PSDG, or the sponsors of the list.

------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) 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.


Avista Pharma Solutions - http://www.avistapharma.com/
   Comprehensive testing and CMC services organization
   Analytical and Microbiology support to early stage API and drug product development and manufacturing.


BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Cincinnati Sub-Zero - http://www.cszindustrial.com/
    Provides a large selection of environmental chambers from benchtop, reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling applications.

=================================
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 PSDG, or the sponsors of the list.

------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) 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.


Avista Pharma Solutions - http://www.avistapharma.com/
   Comprehensive testing and CMC services organization
   Analytical and Microbiology support to early stage API and drug product development and manufacturing.


BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Cincinnati Sub-Zero - http://www.cszindustrial.com/
    Provides a large selection of environmental chambers from benchtop, reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling applications.

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