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Microbio - BIs population verification

Biological indicator population verification following ISO 11138-1 and 11138-2 confirms spore counts meet specifications for sterilization validation. Enumeration through heat shock and plate counting validates BI manufacturers' claims and ensures adequate challenge for sterilization processes. Critical for sterilization validation studies, qualifying new BI lots, and investigating unexpected sterilization results potentially linked to inadequate spore populations.

No.
100901
Method
Spore enumeration by heat shock and plate count
Standard
USP 55, ISO 11138, ISO 11138-1
Stage category
Early Stage, Go to Market, Commercialisation
Industry category
Medical Devices
Analyses category
Microbiology
Sample type
Others
Sample requirement (type)
Non-sterile required
Sample quantities
4 product
Equipment
Manual counting
Lead Time Standard (Days)
10
Lead Time Express (Days)
5
Lead Time Super Express (Days)
3
Accredited
Oui
Test facility
In House
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