3h Steam Test Pack PCD Kit(with one point integrator – yellow) (FDA)
More info about this product
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, ISO 11140-5 |
| Length | 2 m |
Description
KPCD220-1 / Steam Test Pack PCD Kit. Process Challenge Device for Steam sterilization processes, with self-adhesive Type 5 Indicator (Turns from Yellow to Black) and Bionova® Rapid Self-contained Biological Indicator BT220, plus Bionova® BT220 Biological Indicators for 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.
Condition: vacuum-assisted steam sterilization processes at 132/135 °C 4 minutes and gravity-air displacement steam sterilization processes at 121 °C 30 minutes.
Characteristics
Porous cards system holding a Bionova® BT220 Self-contained Biological Indicator and a Chemical Integrator (Type 5 according to ISO 11140-1: 2014) printed on PCDBI-1-RC self-adhesive Record Card, 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. Cardboard box (10.5 cm x 6.5 cm x 1.8 cm approximately) with a Process Indicator (Type 1 according to ISO 11140-1: 2014).
Process Indicator:
Initial color: blue
Final color: dark grey or black
PCDBI-1-RC Chemical Integrator (within the challenge device):
Initial color: yellow
Final color: black
100 % Toxic Heavy Metals free
Integrating 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.
BT220 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).
Final results: fluorescence readout after a 3-hour incubation at 60 ºC (sensitivity 97%). A visual confirmation of the result is optional (color change of the culture medium caused by pH change) and can be made after incubation at 60 °C for 48 hours and/or 7 days.
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
KPCD220-1 / Steam Test Pack PCD Kit. Process Challenge Device for Steam sterilization processes, with self-adhesive Type 5 Indicator (Turns from Yellow to Black) and Bionova® Rapid Self-contained Biological Indicator BT220, plus Bionova® BT220 Biological Indicators for 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.
Condition: vacuum-assisted steam sterilization processes at 132/135 °C 4 minutes and gravity-air displacement steam sterilization processes at 121 °C 30 minutes.
Characteristics
Porous cards system holding a Bionova® BT220 Self-contained Biological Indicator and a Chemical Integrator (Type 5 according to ISO 11140-1: 2014) printed on PCDBI-1-RC self-adhesive Record Card, 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. Cardboard box (10.5 cm x 6.5 cm x 1.8 cm approximately) with a Process Indicator (Type 1 according to ISO 11140-1: 2014).
Process Indicator:
Initial color: blue
Final color: dark grey or black
PCDBI-1-RC Chemical Integrator (within the challenge device):
Initial color: yellow
Final color: black
100 % Toxic Heavy Metals free
Integrating 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.
BT220 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).
Final results: fluorescence readout after a 3-hour incubation at 60 ºC (sensitivity 97%). A visual confirmation of the result is optional (color change of the culture medium caused by pH change) and can be made after incubation at 60 °C for 48 hours and/or 7 days.
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.
