Product type: PCD26‑C Integron® Process Challenge Device (PCD) with IT26‑C Chemical Integrator
Main application: Monitoring steam sterilization cycles in both dynamic‑air‑removal (vacuum assist) and gravity displacement autoclaves; ensures routine monitoring and sterilizer qualification testing
Key benefit: Provides visible migration front with ACCEPT/REJECT zones to confirm sterilization efficacy; incomplete migration indicates penetration failure and prevents load release
Technology / differentiator:
Porous card system containing IT26‑C Chemical Integrator (Type 5, ISO 11140‑1 compliant)
Self‑adhesive Record Card (PCD26‑C‑RC) for documentation of sterilization cycle data
Cardboard box (10.5 × 6.5 × 1.8 cm) with Type 1 Process Indicator printed on the surface
Process Indicator: blue → dark grey/black
Chemical Integrator: migration front visible, calibrated against kill time of Geobacillus stearothermophilus ATCC 7953 spores
FDA 510(k) cleared (K191021) and ANMAT authorized (PM‑1614‑4)
Eco‑friendly 100% toxic heavy‑metal free formulation
Compatibility / usage environment:
United States: Gravity displacement (121 °C, 30 min) / Dynamic air removal (132 °C, 4 min)
Outside US: Gravity displacement (≥30 min at 121 °C) / Dynamic air removal (≥4 min at 132–135 °C)
Not suitable for EO, dry heat, or other sterilization methods