Process Challenge Device

20min Steam Test Pack PCD Kit (with moving front integrator)

Process Challenge Device for Steam sterilization processes with moving-front Type 5 Integrator and Bionova® Ultra Rapid Self-contained Biological Indicator BT224. FDA-cleared.

SKU: KPCD224-C

Category: Process Challenge Device

Brand: Bionova®

Description

Product type

KPCD224‑C Steam Test Pack Kit — Process Challenge Device (PCD) for steam sterilization

Main application

Terragene Bionova® KPCD224-C is designed for a rapid and easy monitoring of steam sterilization processes at 132-135 °C ≥ 4 minutes

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. FDA-cleared

Technology / differentiator

PCD224‑C porous card system containing:
Bionova® BT224 Ultra Rapid SCBI (≥10⁶ Geobacillus stearothermophilus 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

Compatibility / usage environment

For steam sterilization only; suitable for healthcare, food, pharmaceutical, and medical device industries