KPCD224-C / Test Pack PCD Kit. 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.

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 132-135 ºC.

Characteristics:

The kit Consists Of:

PCD224-C: Porous Cards System Holding:

• A Self-contained Biological Indicator Bionova® BT224.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® BT224 (to be used as a positive control)

Specifications:

• Initial Color: Blue.
• Final Color: Dark Grey or Black.
• Process: Steam
• Microorganism: Geobacillus stearothermophilus (ATCC 7953)
• Population: 10^6 Spores/carrier
• Read-Out Time: 20 min
• Regulations: ANSI/AAMI ST79, ISO 11138-3, ISO 11140-1

IT26-C Integrator Indicator (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 spore population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 ºC, 128 ºC, 135 ºC.

BT224 Self-contained Ultra Rapid 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)

Final results: by fluorescence after incubation for 20 minutes at 60 ºC (sensitivity 97%). An optional visual pH color change confirmation could be made after 48 hours of incubation. A 7-day readout is optional to confirm 20-minutes results by color change.

Note: If sterilization process was not successful, indicator medium will turn yellow after incubation, thus indicating the presence of living G. stearothermophilus spores. If sterilization process was successful, indicator medium will remain purple after incubation.