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August 2022

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Subject:
From:
Renee Mickowski <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Mon, 22 Aug 2022 08:43:11 +1000
Content-Type:
text/plain
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Hello Mohab Ameen,
TSP= Terminally sterilised products.

Kind regards,
Renee 

-----Original Message-----
From: Pharmaceutical Stability Discussion Group <[log in to unmask]> On Behalf Of Mohab Ameen Al Desouki
Sent: Wednesday, 17 August 2022 3:43 AM
To: [log in to unmask]
Subject: Re: [PSDGLIST] LAL and sub-visible testing as part of stability testing

What is TSP please?

Sent from my iPhone

> On 16 Aug 2022, at 19:29, Renee Mickowski <[log in to unmask]> wrote:
> 
> ´╗┐Hello,
> 
> Our company is TSP manufacturer and about a couple of years ago due to regulatory audit, we introduced LAL and sub-visible testing into our finished product specification. I have been wondering why the same testing were not included in the stability testing program.
> Does anyone have any input whether if we need to do these testing (i.e. are they stability-indicating tests)? Any expert advise is appreciated.
> 
> Kind regards,
> Renee Mickowski
> 
> =================================
> 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.
> 
> 
> ScienTek - http://www.iStability.com/
>   Provides iStability - Web browser based software for stability management,
>   reporting, testing/data management, statistical data analysis, and more.
> 
> 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

=================================
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.


ScienTek - http://www.iStability.com/
   Provides iStability - Web browser based software for stability management,
   reporting, testing/data management, statistical data analysis, and more.

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

=================================
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.


ScienTek - http://www.iStability.com/
   Provides iStability - Web browser based software for stability management,
   reporting, testing/data management, statistical data analysis, and more.

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

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