Process Challenge Device PCD26-2 Steam
Spore: Geobacillus stearothermophilus (ATCC 7953). in a 105 or 106 population.
Type 5. Applicable regulations: EN 285, ISO 11140-1, ISO 11140-4, ISO 11140-5.
Exposure conditions: 30 min. 121°C or 4 min. 132/134°C. Units per box: 25 PCDs or Individual PCD.
Process Challenge Device Integron® PCD26-2 Test Pack was developed to detect inadequate air removal and steam penetration in dynamic-air removal (pre-vacuum) steam sterilizers at 132/135 °C ? 4 minutes and gravity displacement steam sterilizers at 121 °C ? 30 minutes. The Test Pack consists of a porous barrier system equivalent to the challenge Test Pack specified in ANSI/AAMI ST79, holding in the middle a self-adhesive
Record Card printed with Type 5 Integrator Indicator, where information about the sterilization cycle can be recorded. The indicator ink present on this self-adhesive card was developed to change to a reference color when a theoretical spore population reaches its time of death, indicating integration conditions were achieved. This condition is calibrated with the kill time of a 106 Geobacillus stearothermophilus ATCC 7953 spore
population, calculated in BIER (Biological Indicator Evaluator Resistometer). It also has a Type 1 Process Indicator located on the outside of the package, which allows to quickly identify if it has been exposed to the sterilization process, and to distinguish between processed and unprocessed units.
- Porous cards system holding a Type 5 Integrator Indicator card located in the middle of the package.
- Integrator Indicator is printed on a self-adhesive card, where data on sterilization cycle may be written. 2 possibilities for documentation record: the whole card can be adhered, or alternatively, only the area containing the indicator may be recorded.
- Cardboard box (10.5 cm x 6.6 cm x 1.8 cm) with self-adhesive Type 1