The BI strip should remain inside the filter envelope during testing and
should only be removed aseptically during transfer to growth media for
incubation. The envelope acts as a sterile filter for the BI strip to
ensure no contamination of your strip after sterilization, so removal or
even a tear in the envelope prior to aseptic media transfer may impact your
growth results.
For our clients when we do sterilization validation, we use the self
contained BIs (combined BI strip and growth media in a plastic vial) where
the BI strip has low risk of contamination and a sterile environment is not
needed for media transfer for incubation. Incubation results are also
determined in 24 hours with the self contained BIs.
*Neil Enlow*Division Manager
Performance Validation
*Serving the Life Science Industries since 1988*
cell: 317-341-2819 desk: 317-248-8848 ext. 123
www.perfval.com
*[image: http://www.perfval.com/img5.gif]*
<https://twitter.com/PerfVal> *[image:
http://www.perfval.com/img7.gif]*
<http://www.linkedin.com/company/49774?trk=tyah>
On Tue, Dec 6, 2016 at 10:02 PM, Siti Nurul Afizah Awang Tengah <
[log in to unmask]> wrote:
> 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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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.
|