Remember when looking at the BI CofA that each manufacturer has a
potentially different set of conditions when performing d-Values for VHP --
they aren't fully harmonized yet. So you need to compare your D-Value label
claim to that of the manufacturer ONLY if you have matched their
sterilization conditions. Remember to also review their survival-kill
window on their cert.
-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]]On Behalf Of David Keen
Sent: Tuesday, May 23, 2006 5:01 AM
To: [log in to unmask]
Subject: [PMFLIST] D-Values
Hello Members,
I have a query on performing a system D-value on an isolator system using
VHP at a concentration of 700ppm at 21°C.
Would you expect to see total kill of Geobacillus (population of 1.9x106) on
stainless steel coupons after 35 mins exposure to the above concentration of
VHP?
This is the first system D-value we are performing using VHP. I am unsure as
to whether we have a poor batch of manufactured BI's or if the bugs really
are that resistant to VHP at the given Temp and concentration.
Any comments or thoughts would be appreciated.
Many thanks
David Keen
Microbiologist
Tel: 01661 839266
www.clinical-manufacturing.com <http://www.clinical-manufacturing.com/>
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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
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ATS Laboratories - http://www.ats-labs.com
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Biomerieux - http://industry.biomerieux-usa.com
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