The biological indicator with visual pH reading was designed to ensure vacuum-assisted steam sterilization and gravity air displacement at 121 – 135°C with a response time of up to 24 hours.
The reading is done by visualizing the color change due to the acidification of the culture medium, which changes from purple to yellow when the process fails.
A “dead” organism is considered when:
* There is no proliferation in culture media that once showed proliferation
* The probability of survival of the organism is less than 10-6 CFU
We consider an article sterile when the probability of survival of microorganisms is less than 1:1,000,000
“Standardized preparation containing live and viable microorganisms, known to be resistant to the sterilization method to be monitored, and whose objective is to demonstrate whether the conditions in the sterilizer are adequate to produce sterilization” Favero, 1998
Yes, Hygia Bio’s indicators can be read on the main readers on the market!
For assured quality, a biological indicator must be packaged within a process challenge device (PCD) and used to monitor each load of material containing sterilized critical medical devices or implants. The number of packages must be proportional to the size of the autoclave.
