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1h Steam Test Pack (with one point integrator - yellow)

Brand

Bionova

Process

Steam

Packaging

Single PCD

Microorganism

Geobacillus Stearothermophilus (ATCC 7953)

Population

10^6

Read-Out Time

1 h

Conditions

See Product Description

Regulations

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

Description

PCD222-1 / Process Challenge Device for Steam sterilization processes with self-adhesive Class 5 Integrator Indicator (Turns from Yellow to Black) and Bionova® Super Rapid Self-contained Biological Indicator BT222.

For routine load release, especially for loads containing implants. For routine sterilizing monitoring, and for periodic validation of the sterilizer.

Detects inadequate air removal and steam penetration in dynamic air-removal (pre-vacuum) and gravity air-displacement steam sterilization processes between 121°C – 135°C.

Instructions for use

1- Place the pack inside a normally loaded steam autoclave. Place it in areas which you consider a priori most inaccessible for the sterilizing agent (high temperature steam). Generally, the center of the load and areas on the bottom shelf near the door and over the drain are problematic.

2- Run the sterilization cycle: 132/135 ºC dynamic-air-removal steam sterilization processes 4 minutes 121 ºC gravity displacement steam sterilization processes 30 minutes

3- After the sterilization process has finished, open the sterilizer door, wait for 5 minutes and remove the test pack. NOTE: The color of the box design may vary from the original color after undergoing the sterilization cycle. This does not represent a problem regarding the operation or quality of the product.

4- Check that the external process indicator color on the outside of the test pack has changed. Open the test pack, wait 5 minutes and remove the SCBI. Allow it to cool down to room temperature. PRECAUTION: Wear safety glasses and gloves when removing the biological indicator from the sterilized test pack. WARNING: Do not crush or handle the biological indicator excessively, since this might cause the glass ampule to burst.

5- Check the chemical integrator on the Record Card for correct exposure. Color change to the reference confirms that the inside of the pack has been exposed to sufficient sterilization conditions. Otherwise, check the sterilization process.

6- Check the process indicator on the label of the biological indicator. A color change to brown confirms that the biological indicator has been exposed to steam. IMPORTANT: This color change does not indicate that the process was sufficient to achieve sterility.

7- Identify the Bionova® BT222 SCBI by writing the sterilizer number (in case of having more than one sterilizer), load number, and processing date on the label. Fill out the required information on the Record Card.

8- Crush the glass ampule contained in the SCBI. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spores carrier entirely. Incubate at (60 ± 2) ºC in a compatible Bionova® autoreader/incubator.

IMPORTANT: Use a non-sterilized biological indicator as a positive control whenever processed biological indicator is incubated. The positive control ensures that appropriate incubation conditions are met. Both the positive control indicator and the processed indicator should belong to the same batch. The indicator used as positive control must yield a positive result.

9- Incubate the processed biological indicator and the indicator used as positive control for 1 hour at (60 ± 2)°C to get the final fluorescence result. A 48-hour readout is optional to confirm the 1-hour result by visual color change.

A positive fluorescence result (or growth medium color change during the 48-hour optional incubation) of the sterilized biological indicator means a sterilization process failure has occured. If a negative fluorescence result is obtained (or growth medium remains the original color after the incubation period) the sterilization process was satisfactory.

10- Wait for the final results. Fill out the SCBI results and adhere the self-adhesive whole Record Card or alternatively, only the area containing the integrator indicator. WARNING: Do not use the sterilizer until the biological indicator test results are negative.

11- Discard the test pack and SCBI immediately

Description

PCD222-1 / Process Challenge Device for Steam sterilization processes with self-adhesive Class 5 Integrator Indicator (Turns from Yellow to Black) and Bionova® Super Rapid Self-contained Biological Indicator BT222.

For routine load release, especially for loads containing implants. For routine sterilizing monitoring, and for periodic validation of the sterilizer.

Detects inadequate air removal and steam penetration in dynamic air-removal (pre-vacuum) and gravity air-displacement steam sterilization processes between 121°C – 135°C.

Instructions for use

1- Place the pack inside a normally loaded steam autoclave. Place it in areas which you consider a priori most inaccessible for the sterilizing agent (high temperature steam). Generally, the center of the load and areas on the bottom shelf near the door and over the drain are problematic.

2- Run the sterilization cycle: 132/135 ºC dynamic-air-removal steam sterilization processes 4 minutes 121 ºC gravity displacement steam sterilization processes 30 minutes

3- After the sterilization process has finished, open the sterilizer door, wait for 5 minutes and remove the test pack. NOTE: The color of the box design may vary from the original color after undergoing the sterilization cycle. This does not represent a problem regarding the operation or quality of the product.

4- Check that the external process indicator color on the outside of the test pack has changed. Open the test pack, wait 5 minutes and remove the SCBI. Allow it to cool down to room temperature. PRECAUTION: Wear safety glasses and gloves when removing the biological indicator from the sterilized test pack. WARNING: Do not crush or handle the biological indicator excessively, since this might cause the glass ampule to burst.

5- Check the chemical integrator on the Record Card for correct exposure. Color change to the reference confirms that the inside of the pack has been exposed to sufficient sterilization conditions. Otherwise, check the sterilization process.

6- Check the process indicator on the label of the biological indicator. A color change to brown confirms that the biological indicator has been exposed to steam. IMPORTANT: This color change does not indicate that the process was sufficient to achieve sterility.

7- Identify the Bionova® BT222 SCBI by writing the sterilizer number (in case of having more than one sterilizer), load number, and processing date on the label. Fill out the required information on the Record Card.

8- Crush the glass ampule contained in the SCBI. Then shake the tube down vigorously, with movements similar to those performed to lower the temperature in a mercury thermometer, until the medium reaches the base of the tube and soaks the spores carrier entirely. Incubate at (60 ± 2) ºC in a compatible Bionova® autoreader/incubator.

IMPORTANT: Use a non-sterilized biological indicator as a positive control whenever processed biological indicator is incubated. The positive control ensures that appropriate incubation conditions are met. Both the positive control indicator and the processed indicator should belong to the same batch. The indicator used as positive control must yield a positive result.

9- Incubate the processed biological indicator and the indicator used as positive control for 1 hour at (60 ± 2)°C to get the final fluorescence result. A 48-hour readout is optional to confirm the 1-hour result by visual color change.

A positive fluorescence result (or growth medium color change during the 48-hour optional incubation) of the sterilized biological indicator means a sterilization process failure has occured. If a negative fluorescence result is obtained (or growth medium remains the original color after the incubation period) the sterilization process was satisfactory.

10- Wait for the final results. Fill out the SCBI results and adhere the self-adhesive whole Record Card or alternatively, only the area containing the integrator indicator. WARNING: Do not use the sterilizer until the biological indicator test results are negative.

11- Discard the test pack and SCBI immediately

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