1h Steam Test Pack PCD Kit (with moving front integrator) (FDA)

KPCD222-C / Test Pack PCD Kit. Process Challenge Device for Steam sterilization processes with moving-front Type 5 Indicator and Bionova® Super Rapid Self-contained Biological Indicator BT222, plus Bionova® BT222 Biological Indicators Positive Control.

For routine load release, especially for loads containing implants. For routine sterilizer monitoring. For periodic validation of the sterilizer (after installation, repair, relocation).

Detects inadequate air removal and steam penetration in dynamic-airremoval (pre-vacuum) and gravity displacement steam autoclaves between 121-135 ºC. Please review the instructions for use for applicable cycles in your country

Characteristics

The kit consist of:

– PCD222-C: Porous cards system holding:

-A Self-contained Biological Indicator Bionova® BT222.

-A Type 5 chemical indicator Integron® IT26-C (moving-front integrator).

-A self-adhesive Record Card, PCDBI-C-RC, where data on sterilization cycle may be written.

– Self-contained Biological Indicator Bionova® BT222 (to be used as a

positive control)

Process Indicator:

Initial color: blue

Final color: dark grey or black

IT26-C Chemical Integrator (within the challenge device) The migration is visible through a zone marked ACCEPT or REJECT, thus indicating whether sterilization conditions were met. Integration condition is calibrated against the kill time of a 106 G. stearothermophilus ATCC 7953 spores€™ population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 °C, 128 °C, 135 °C.

BT222 Super Rapid Self-contained Biological Indicator (within the challenge device): ‰¥106 G. stearothermophilus ATCC 7953 spores per vial in paper carrier. Glass ampoule with growth indicator medium.

Label with chemical indicator line printed with Steam reactive ink (Color change: pink to brown)