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3h Steam Test Pack PCD Kit (with one point integrator – purple) (FDA)

SKU: KPCD220-2 Category: Tags ,

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

3 h

Regulations

ANSI/AAMI ST79, ISO 11138-3, ISO 11140-1

Description

KPCD220-2 / 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® 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 between 121-135 °C.

Characteristics

The kit consist of:

– PCD220-2: Porous cards system holding:

A Self-contained Biological Indicator Bionova® BT220.

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® BT220 (to be used as a positive control).

Process Indicator:

Initial color: blue

Final color: dark grey or black

PCDBI-2-RC Chemical Integrator (within the challenge device):

Initial color: purple

Final color: green

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.Steam Test Pack PCD Kit Process Challenge Device for Steam sterilization processes.

Infection Control Division | Chemical Indicators

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 3-hour incubation at 60 °C (sensitivity 97%). A visual confirmation of the result is optional (culture medium color change caused by pH change) and can be made after incubation at 60 °C for 48 hours and/or for 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

KPCD220-2 / 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® 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 between 121-135 °C.

Characteristics

The kit consist of:

– PCD220-2: Porous cards system holding:

A Self-contained Biological Indicator Bionova® BT220.

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® BT220 (to be used as a positive control).

Process Indicator:

Initial color: blue

Final color: dark grey or black

PCDBI-2-RC Chemical Integrator (within the challenge device):

Initial color: purple

Final color: green

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.Steam Test Pack PCD Kit Process Challenge Device for Steam sterilization processes.

Infection Control Division | Chemical Indicators

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 3-hour incubation at 60 °C (sensitivity 97%). A visual confirmation of the result is optional (culture medium color change caused by pH change) and can be made after incubation at 60 °C for 48 hours and/or for 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.

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