Product type: KPCD220‑2 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:
PCD220‑2 porous card system containing:
Bionova® BT220 Rapid SCBI (≥10⁶ Geobacillus stearothermophilus ATCC 7953 spores per vial)
PCDBI‑2‑RC Type 5 Chemical Integrator (ISO 11140‑1:2014) with self‑adhesive Record Card for documentation
External Process Indicator (Type 1): blue → dark grey/black
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)
100% toxic heavy‑metal free formulation
Compatibility / usage environment: For steam sterilization only; suitable for healthcare, food, pharmaceutical, and medical industries