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, plus Bionova® BT224 Biological Indicators Positive Control. Class 5 spores per strip.
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
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 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