1h Steam Test Pack (with one point integrator – purple) (FDA)

PCD222-2 / 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.

For routine load release, especially for loads containing implants. For routine sterilizing monitoring, and for periodic validation of the sterilizer (after installation, repair, relocation).

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, in those areas which are considered most inaccessible for the sterilizing agent (e.g., the center of the load and areas near the door).

2- Run the sterilization cycle.

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 may vary from the original after undergoing the sterilization cycle. This does not represent a problem regarding the operation or quality of the product.

4- Check that the process indicator printed on box has changed color from light blue to grey. 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 ampoule to burst.

5- Check the chemical integrator on the Record Card for correct exposure. Color change to green confirms that the inside of the pack has been exposed to correct sterilization conditions. For chemical integrator reference color, please refer to Result Reference Guide. Otherwise, check the sterilization process.

6- Check the process indicator printed on SCBI ´s label. 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), load number, and processing date on the label. Fill out the required information on the Record Card.

8- Press the cap to seal the tube. Crush the glass ampoule contained in the SCBI with an individual ampoule crusher or with the ampoule crusher placed within the incubator s incubation area. 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 spore carrier entirely.

IMPORTANT: Use a non-sterilized biological indicator as a positive control in order to ensure that correct incubation conditions were met; capability of culture medium to promote rapid growth; no alteration of spore€™s viability due to improper storage temperature, humidity or proximity to chemicals and also correct functioning of Terragene® Bionova® Auto-reader Incubator. Both, the positive control indicator and the processed indicator, should belong to the same batch.

9- Incubate the processed biological indicator and the indicator used as positive control in Terragene® Bionova® Auto-reader Incubators 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 culture medium color change after the 48-hour incubation) means failure of sterilization process. If a negative fluorescence result is obtained (or culture medium remains the original color after 48-hour incubation), it means that sterilization process was successful.

10- Record the SCBI and integrator results and adhere the self-adhesive 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 pack and the indicators immediately.