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3h Steam Test Pack PCD Kit (with moving front integrator)

Brand

Bionova

Process

Steam

Packaging

Kit with 25 PCDs + 25 SCBIs

Microorganism

Geobacillus Stearothermophilus (ATCC 7953)

Population

10^6

Read-Out Time

3 h

Conditions

See Product Description

Regulations

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

Description

KPCD220-C / Test Pack PCD Kit. Process Challenge Device for Steam sterilization processes with moving-front Type 5 Indicator and Bionova® Self-contained Biological Indicator BT220, plus Bionova® BT220 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.

Characteristics

The kit consist of:

– PCD220-C: Porous cards system holding:

A Self-contained Biological Indicator Bionova® BT220.

A Type 5 chemical integrator 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® BT220 (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.

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 (color change of the medium 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-C / Test Pack PCD Kit. Process Challenge Device for Steam sterilization processes with moving-front Type 5 Indicator and Bionova® Self-contained Biological Indicator BT220, plus Bionova® BT220 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.

Characteristics

The kit consist of:

– PCD220-C: Porous cards system holding:

A Self-contained Biological Indicator Bionova® BT220.

A Type 5 chemical integrator 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® BT220 (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.

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 (color change of the medium 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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