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September 2011

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Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 31 Aug 2011 23:17:05 -0700
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On Fri, Aug 26, 2011 at 7:44 AM, Silver, David
<[log in to unmask]> wrote:
> Min,
> My initial thought is yes. The simulated full mapping is performed to demonstrate the chamber will hold conditions if airflow is disrupted by sample loading. Continued mapping in the as found condition every three years lends well to the argumement. However, at its next scheduled event, or earlier, you could use the cartons and re-qualify again as simulated full if you are concerned or have noticed a variance in trending for the chamber as a result of the packaging change.
>
>
> David
>
>
>
>
> -----Original Message-----
> From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Min He
> Sent: Thursday, August 25, 2011 1:36 PM
> To: [log in to unmask]
> Subject: Re: [PSDGLIST] Question regarding stability chamber requalification
>
> Thanks for the response.
>
> My walk-in chamber was initially qualified with both empty and loaded
> condition. However, at that time, the samples were packaged in plastic
> bins which can hold up to 200 samples. Now, we package all the sampels
> in individual carton boxes which can hold at most 5 samples per box.
> With this change, can we still use the inital "loaded" qualification?
>
> Thanks a lot!
>
>
>
> 2011/8/24  <[log in to unmask]>:
>> We re-map every 3 years with the chambers under their current load conditions.  Our initial qualification covered empty, full and half-full loads.
>>
>> Roy
>>
>> -----Original Message-----
>> From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Min He
>> Sent: Sunday, August 21, 2011 11:12 PM
>> To: [log in to unmask]
>> Subject: [PSDGLIST] Question regarding stability chamber requalification
>>
>> Hi there,
>>
>> I would like to gain some idea regarding stability chamber
>> requalification and would appreciate if you could share with me your
>> experience.
>>
>> 1. How often do you re-qualify them?
>> 2. For re-qualification, is it sufficient to map the chambers with the
>> contents of the chamber as is? Is mapping with the empty and full
>> chambers required?
>>
>> Thanks a lot for your input!
>> Min
>>
>> =================================
>> 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.
>>
>> Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
>>   High quality controlled environmental walk-in rooms and reach-in chambers
>>   Full installation, validation and spare parts also available
>>
>> Environmental Specialties - http://www.eschambers.com/
>>   Manufacturer of Quality Stability Chambers and
>>   Provider of Complete Validation & Calibration Services
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>> =================================
>> 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.
>>
>> Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
>>   High quality controlled environmental walk-in rooms and reach-in chambers
>>   Full installation, validation and spare parts also available
>>
>> Environmental Specialties - http://www.eschambers.com/
>>   Manufacturer of Quality Stability Chambers and
>>   Provider of Complete Validation & Calibration Services
>>
>
> =================================
> 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.
>
> Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
>   High quality controlled environmental walk-in rooms and reach-in chambers
>   Full installation, validation and spare parts also available
>
> Environmental Specialties - http://www.eschambers.com/
>   Manufacturer of Quality Stability Chambers and
>   Provider of Complete Validation & Calibration Services
>
> =================================
> 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.
>
> Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
>   High quality controlled environmental walk-in rooms and reach-in chambers
>   Full installation, validation and spare parts also available
>
> Environmental Specialties - http://www.eschambers.com/
>   Manufacturer of Quality Stability Chambers and
>   Provider of Complete Validation & Calibration Services
>

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

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Environmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers and
   Provider of Complete Validation & Calibration Services

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