Process Challenge Device
1h Steam Test Pack PCD Kit (with one point integrator)
Process Challenge Device for Steam sterilization processes with self-adhesive Type 5 Indicator and Bionova® Super Rapid Self-contained Biological Indicator BT222.
SKU: KPCD222-2
Category: Process Challenge Device
Brand: Bionova®
Description
Product type
PCD222‑2 Steam Test Pack Kit — Process Challenge Device (PCD) for steam sterilization
Main application
Routine release of steam‑sterilized loads, especially implants; routine sterilizer monitoring; periodic validation after installation, repair, or relocation
Key benefit
Detects inadequate air removal and steam penetration in pre‑vacuum and gravity displacement autoclaves (121–135 °C), ensuring reliable sterilization of critical loads
Technology / differentiator
Porous card system containing: Bionova® BT222 Super Rapid SCBI (≥10⁶ Geobacillus stearothermophilus spores per vial) PCDBI‑2‑RC Type 5 Chemical Integrator (ISO 11140‑1:2014) printed on self‑adhesive Record Card for documentation External Process Indicator (Type 1): light blue → dark grey/black Chemical Integrator: purple → green, calibrated against kill time of G. stearothermophilus spores in BIER resistometer SCBI label with steam‑reactive ink: pink → brown Designed under ISO 13485:2016, ISO 11140‑1:2014, ISO 11138‑1:2017, ISO 11138‑3:2017, ANSI/AAMI ST79 standards Authorized by ANMAT (PM 1614‑4) and FDA 510(k) K163646 100% toxic heavy‑metal free formulation
Compatibility / usage environment
For steam sterilization only; suitable for healthcare, food, pharmaceutical, and medical industries