Product type: KPCD110 Test Pack Kit — Process Challenge Device (PCD) for ethylene oxide sterilization
Main application: Routine release of ethylene oxide sterilized loads, sterilizer monitoring, and periodic validation (installation, repair, relocation)
Key benefit: Provides a complete validation system combining a process challenge device with a self‑contained biological indicator, ensuring reliable EO sterilization monitoring
Technology / differentiator:
PCD110: PET process challenge system designed to test sterilant penetration to the spore population of Bionova® BT110 SCBI
External process indicator: pink → orange (pH change) after EO exposure
BT110 SCBI: ≥10⁶ spores of Bacillus atrophaeus ATCC® 9372 per vial on paper carrier, glass ampoule with growth medium
Chemical indicator line on label: brown → green after EO exposure
Final results:
Fluorescence reading after 4 hours at 37 °C (sensitivity ≥97%)
Optional visual confirmation after 48 hours or 7 days (blue = sterile, yellow = growth)
Designed under ISO 13485:2016, ISO 11138‑1:2017, ISO 11138‑2:2017, ISO 11140‑1:2014 standards
Authorized by ANMAT (PM 1614‑1)
Compatibility / usage environment: For EO sterilization only; suitable for healthcare, food, pharmaceutical, and medical industries