There are a couple of possibilities: improper seating and/or deterioration of gaskets in the vessel's access points, faulty vacuum pump, or gases in supply line(s) which prevent steam from fully penetrating cold spots within the chamber.
Bowie-Dick and Vacuum Leak Test.
“...industry standards call for an average leak rate of 1mmHG/min or less"
https://my.aami.org/aamiresources/previewfiles/ST8_1304_preview.pdf
https://consteril.com/autoclave-steam-sterilization-cycle-bowie-dick-test/
Bob
> On Dec 1, 2017, at 4:53 AM, RC PANTOLA <[log in to unmask]> wrote:
>
> Dear All,
>
> I am not sure about this group is only for stability and or for
> microbiology also?
>
> If this is for microbiology also, Please suggest the limit of vacuum leak
> test for sterilization cycles of steam sterilizer, mainly for the vacuum
> cycles. As the stem sterilizer becomes older the limit for vacuum leak test
> cycles suggested by the manufacture could not achieved easily. Please share
> the guidelines and industrial practices.
>
>
>
> Thanks and regards
>
>
>
> Dr.R.C.Pantola
>
>
>
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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.
|
