4h Ethylene Oxide Sterilization Test Pack PCD Kit

25 st. PCD110 + 25 st. BT110 /enhet
Art.nr: KPCD110

Process Challenge Device (KPCD110) for Ethylene Oxide sterilization processes.

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.


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