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Additional information
| Brand | Bionova |
|---|---|
| Process | Steam |
| Packaging | Kit with 25 PCDs + 25 SCBIs |
| Microorganism | Geobacillus stearothermophilus (ATCC® 7953) |
| Population | 10^6 Spores/carrier |
| Read-Out Time | 1 h |
| Regulations | ANSI/AAMI ST79, ISO 11138-3, ISO 11140-1 |
| Field of activity | Dental, Healthcare |
Description
KPCD222-2 / Steam Test Pack PCD Kit. Process Challenge Device for Steam sterilization processes, with self-adhesive Type 5 Indicator (Turns from Purple to Green) and Bionova® Super Rapid Self-contained Biological Indicator BT222, plus Bionova® BT222 Biological Indicators Positive Control.
FDA cleared
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 °C. Please review the instructions for use for applicable cycles in your country
Characteristics
The kit consist of:
– PCD222-2: Porous cards system holding:
A Self-contained Biological Indicator Bionova® BT222.
A Type 5 chemical indicator.
A self-adhesive Record Card, PCDBI-2-RC, where data on sterilization cycle may be written.
Two possibilities for documentation record: the whole Record Card can be adhered, or alternatively, only the area containing the indicator may be recorded.
Self-contained Biological Indicator Bionova® BT222 (to be used as a positive control)
Process Indicator:
Initial color: blue.
Final color: dark grey or black.
PCDBI-2-RC Integrator Indicator (within the challenge device):
Initial color: purple.
Final color: green.
100 % Toxic Heavy Metals free.
Integration condition is calibrated against the kill time of a 106 G. stearothermophilus ATCC 7953 spore population, calculated in BIER (Biological Indicator Evaluator). Conditions: saturated steam at 121 ºC, 128 ºC, 135 ºC.
Self-contained Super Rapid Biological Indicator BT222 (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 1 hour at 60 ºC (sensitivity 97%).A 7-day readout is optional to confirm 1-hour 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.
Description
KPCD222-2 / Steam Test Pack PCD Kit. Process Challenge Device for Steam sterilization processes, with self-adhesive Type 5 Indicator (Turns from Purple to Green) and Bionova® Super Rapid Self-contained Biological Indicator BT222, plus Bionova® BT222 Biological Indicators Positive Control.
FDA cleared
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 °C. Please review the instructions for use for applicable cycles in your country
Characteristics
The kit consist of:
– PCD222-2: Porous cards system holding:
A Self-contained Biological Indicator Bionova® BT222.
A Type 5 chemical indicator.
A self-adhesive Record Card, PCDBI-2-RC, where data on sterilization cycle may be written.
Two possibilities for documentation record: the whole Record Card can be adhered, or alternatively, only the area containing the indicator may be recorded.
Self-contained Biological Indicator Bionova® BT222 (to be used as a positive control)
Process Indicator:
Initial color: blue.
Final color: dark grey or black.
PCDBI-2-RC Integrator Indicator (within the challenge device):
Initial color: purple.
Final color: green.
100 % Toxic Heavy Metals free.
Integration condition is calibrated against the kill time of a 106 G. stearothermophilus ATCC 7953 spore population, calculated in BIER (Biological Indicator Evaluator). Conditions: saturated steam at 121 ºC, 128 ºC, 135 ºC.
Self-contained Super Rapid Biological Indicator BT222 (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 1 hour at 60 ºC (sensitivity 97%).A 7-day readout is optional to confirm 1-hour 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.
