Hi Ken,
During the validation of autoclave,the strip is placed as such with the
envelope.
Regards
Prashanth N
On 08-Dec-2016 12:09 AM, "David Brodersen" <[log in to unmask]> wrote:
The D-Value for the BI lot being used is established with the BI strip
within the glassine envelope. Thus, it is not recommended to remove
necessary for BI placement.
David Brodersen
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]
MICROBIOLOGYNETWORK.COM] On Behalf Of Siti Nurul Afizah Awang Tengah
Sent: Tuesday, December 06, 2016 10:02 PM
To: [log in to unmask]
Subject: [PSDGLIST] Autoclave validation using biological indicator
Dear forum members,
We are trying to validate autoclave using the biological indicator
(Sterility indicator strips from Sigma-Aldrich). My question is, when we
put the indicators inside the autoclave at specify locations, do we need to
put the strip with the envelope or without the envelope? Kindly advice on
this. Sorry for the stupid question.
Regards,
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.
|
