Product type: KPCD224‑C Steam Test Pack Kit — Process Challenge Device (PCD) for steam sterilization
Main application: Routine release of steam‑sterilized loads, especially implants; routine sterilizer monitoring; qualification testing and periodic validation after installation, repair, or relocation
Key benefit: Provides a defined challenge equivalent to the ANSI/AAMI 16‑towel pack, ensuring robust monitoring of steam sterilization performance in both pre‑vacuum and gravity displacement autoclaves
Technology / differentiator:
PCD224‑C porous card system containing:
Bionova® BT224 Ultra Rapid SCBI (≥10⁶ Geobacillus stearothermophilus ATCC 7953 spores per vial)
Integron® IT26‑C Type 5 moving‑front chemical integrator with clear ACCEPT/REJECT zones for easy interpretation
PCDBI‑C‑RC self‑adhesive Record Card for sterilization cycle documentation
External Process Indicator (Type 1): blue → dark grey/black
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, ISO 11138‑8:2021, ANSI/AAMI ST79:2017 standards
Authorized by ANMAT (PM 1614‑4) and FDA 510(k) K191021
100% toxic heavy‑metal free formulation
Compatibility / usage environment: For steam sterilization only; suitable for healthcare, food, pharmaceutical, and medical device industries