For routine release of Ethylene Oxide sterilized loads. For routine sterilizer monitoring. For periodic validation of the sterilizer (after installation, repair, relocation).
Each pack kit consists of 25 PCD110 + 25 BT110 Biological Indicators per box:
PCD110: PET process challenge system designed to challenge the path and arrival of the sterilizing agent to the Bacillus atrophaeus spore population of a Bionova’ BT110 Self-Contained Biological Indicator. On its outer side, the Bionova®’ PCD110 process challenge device also contains a Process Indicator that turns orange after exposure.
Process Indicator Initial color: pink Final color: orange
Self-contained Biological Indicator Bionova® BT110 (inside the challenge device): 106 spores of Bacillus atrophaeus ATCC 9372 per vial on a paper carrier. Glass ampoule with growth indicator medium. Label with chemical indicator line printed with Ethylene Oxide reactive ink (color change: brown to green).
Final results: fluorescence reading after incubation for 4 hours at 37 °C (sensitivity 97 %). Optionally, visual confirmation of the result (color change of the medium due to pH change) can be performed after 48 hours and seven days of incubation at 37 °C. NOTE: If the sterilization process is unsuccessful, the culture medium will change to yellow during incubation at 37 °C after 48 hours, indicating the presence of live spores. If the sterilization process is successful, the indicator medium will remain blue after incubation.
Shelf life 2 years.