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
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Comprehensive testing and CMC services organization
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development and manufacturing.
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Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers
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Ultra Low Storage Chambers with Complete Validation, Maintenance &
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Cincinnati Sub-Zero - http://www.cszindustrial.com/
Provides a large selection of environmental chambers from benchtop,
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rooms along with chambers for freeze/thaw, temperature cycling
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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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