Hi Eric,
Emil's comment is cogent and the simplest solution to cycling studies (under most circumstances). However, if you need to qualify a cycling chamber for your operations then you have to adopt acceptance criteria which are within the chamber's capabilities. Not sure why ramping speed would be critically important but you should stretch those ramp time acceptance criteria out to match demonstrated chamber performance. After all, the chamber can only do what it can do.
If the answer to Tony Cundell's question is no (it is not designed for cycling) then I would not use that chamber and either go to Emil's suggestion or purchase a chamber which is designed for your needs.
Bob Friedel's comments are spot on for the red flag about averaging but, if time is a resource in short supply, one exception could be to isolate a section of the chamber which did meet the criteria (not averaged to pass) and cordon it off. Then demonstrate sample traceability that you restricted placement of samples within that zone. This is not a preferred approach but it is potentially valid for a given study. Ask your QA first.
I am sure there are other approaches which may be satisfactory.
Good luck!
Michael
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-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Emil Friedman
Sent: Tuesday, November 28, 2017 2:57 PM
To: [log in to unmask]
Subject: [Junk] Re: [PSDGLIST] Cycling program validation protocol
Why cycle the entire chamber? Why not just move the material from chamber to chamber?
-------------------------------------------
Emil M Friedman, PhD
880 Salem Ave
Hillside, NJ 07205-3035
908-355-8319 (home phone number)
216-287-0821 (cell)
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http://www.statisticalconsulting.org
On Mon, Nov 27, 2017 at 4:18 PM, Eric Hammang <[log in to unmask]> wrote:
> Hello All,
>
> It has been recommended we update the validation protocol and studies
> for a stability chamber that will begin being used for a cycling study.
> The program has 4 phases and takes 8 hours to complete before
> beginning again. It holds at -3C° for 3 hours, ramp to 40C° in 1 hour,
> holds 40C° for
> 3 hours, ramp to -3C° in 1 hour, and repeat.
>
> In review of our last study, we used 16 thermocouples placed
> methodically and consistently throughout a 40sq. ft. walk-in chamber
> and I am finding that the 1 hour ramp period for both warming or
> cooling (plus a 15 minute stabilization period written into the
> protocol) was still not enough time to get all thermocouples ±2C° of
> specified temperature. At the time the study was conducted it appears
> the results of the 16 temps may have been averaged to meet the
> necessary criteria. We do not average temp readings for our other
> constant environment stability chambers validation studies and am
> unable to find any reference indicating it is ok for cycling validation studies.
>
> The data indicates that some thermocouples took a total of 45 minutes
> into the 3 hour holding period after the 1 hour ramp period ended for
> stabilization within that ±2C°.
>
> Does anyone have experience dealing with a similar scenario? I am
> seeking guidance for what type of language to use that offers an
> appropriate defense if scrutinized.
>
> I am unable to change the cycling program times or temperatures. Also,
> the controller is working as intended with the input received from the
> thermocouple and it is capable of ramping faster when needed. For
> example, it took about 33 minutes to cool from 55C° to -3C° when being
> checked in a manual operation mode.
>
> In these instances the chamber is running empty. We will also be
> simulating an approximate load of between 60-70% of the space in
> separate studies.
>
> Any help is much appreciated.
>
> Kind regards,
>
> Eric Hammang
>
>
>
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> ScienTek - http://www.iStability.com/
> Provides iStability® - Web browser based software for stability
> management,
> reporting, testing/data management, statistical data analysis, and more.
>
> 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.
ScienTek - http://www.iStability.com/
Provides iStability® - Web browser based software for stability management,
reporting, testing/data management, statistical data analysis, and more.
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.
ScienTek - http://www.iStability.com/
Provides iStability® - Web browser based software for stability management,
reporting, testing/data management, statistical data analysis, and more.
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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