Process Challenge Device
4h Ethylene Oxide Sterilization Test Pack PCD Kit
Process Challenge Device (KPCD110) for Ethylene Oxide sterilization processes. Usage For routine release of Ethylene Oxide sterilized loads.
SKU: KPCD110
Category: Process Challenge Device
Brand: Bionova®
Description
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 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