Process Challenge Device

20min Steam Test Pack PCD Kit (with one point integrator)

Steam Test Pack PCD Kit. Process Challenge Device for Steam sterilization processes, with self-adhesive Type 5 Indicator and Bionova® Ultra Rapid Self-contained Biological Indicator BT224. FDA-cleared.

SKU: KPCD224-2

Category: Process Challenge Device

Brand: Bionova®

Description

Product type

KPCD224‑2 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 (132–135 °C), ensuring reliable sterilization of critical loads. FDA-cleared

Technology / differentiato

PCD224‑2 porous card system containing:
Bionova® BT224 Ultra Rapid SCBI (≥10⁶ Geobacillus stearothermophilus 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
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)

Compatibility / usage environment

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