Process challenge device (KPCD110) for ethylene oxide sterilization processes. Bacillus atrophaeus (ATCC® 9372) 10⁶ spores per vial. Readout: 4 hours. 25PCD+25BI/BX.

• Consistent and reliable spore population
• Sensitivity >97%
• Shelf-life: 2 years
• Must be read with Bionova autoreaders (VWR part 77506-948)

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. 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.

Storage conditions:
T = 10 to 30 °C, RH = 30 to 80%, keep the product away from direct light.