It's not a stupid question!
We keep the BI in the glassine envelope unless we're validating tubing, narrow piping, etc., in which case we remove the BI from the envelope and test the "naked" spore strip as it's easier to fit into tight spaces. However, it's pretty rare that we do this. Hope this helps!
-Cara
Cara Yelland
Quality Specialist
InSite Vision, Inc.,
a Sun Pharma Company
-----Original Message-----
From: Siti Nurul Afizah Awang Tengah [mailto:[log in to unmask]]
Sent: Tuesday, December 06, 2016 7:02 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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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.
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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.
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