The post Steam Test Pack PCD Kit – 7 Second Readout first appeared on Terragene.

FDA cleared

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 132-135 °.

Please review the instructions for use for applicable cycles in your country

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 IT26-C moving front chemical integrator for correct exposure. If the dark bar has reached the ACCEPT zone, this 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® BT224 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, until the medium reaches the base of the tube and soaks the spore carrier entirely. Incomplete wetting of the spore carrier may lead to an incorrect fluorescence readout.

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 20 minutes at (60 ± 2) °C to get the final fluorescence result. A 48-hour readout is optional to confirm the 20-minute 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

The post 20min Steam Test Pack (with moving front integrator) first appeared on Terragene.

FDA cleared

Integron® PCD26-C Process Challenge Device (PCD) Test Pack has been designed to simulate a load to be sterilized and to pose a challenge to the sterilization process. It is used to evaluate the effective performance of the process by detecting inadequate air removal and steam penetration. Furthermore, it allows to perform the routine monitoring and periodic validation of the sterilizers (after repair, installation, relocation).

Integron® PCD26-C consists of a disposable pre-assembled package as outlined in ANSI/AAMI ST79 which contains in the middle an IT26-C moving front chemical integrator (Type 5 according to ISO 11140-1:2014 standard) and a PCD26-C-RC self-adhesive Record Card where sterilization cycle information can be recorded.

The extent of migration of the dark bar along the ACCEPT/REJECT zone of the integrating indicator indicates whether sterilization conditions were met or not. The ACCEPT result is reached when a theoretical spores population reaches its kill time, indicating integration condition has been reached.

This condition is calibrated with the kill time of a 106 Geobacillus stearothermophilus ATCC 7953 spores population, calculated in a BIER (Biological Indicator Evaluator Resistometer).

This pack also has a process indicator (Type 1 according to ISO 11140-1:2014 standard) printed on the outside of the package, which allows to quickly identify if it has been exposed to the sterilization process (color change from light blue to grey), and to distinguish between processed and unprocessed items.

Please review the instructions for use for applicable cycles in your country

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 and remove the integrating indicator. PRECAUTION: Wear safety glasses and gloves when removing the indicator from the sterilized test pack.

5- Check IT26-C moving front chemical integrator for correct exposure. If the dark bar has reached the ACCEPT zone, this confirms that the inside of the pack has been exposed to sufficient sterilization conditions. For chemical integrator reference change, please refer to Result Reference Guide. Otherwise, check the sterilization process.

6- Fill out the required information on the Record Card.

7- Discard the pack immediately

The post Test pack PCD for Steam ( with moving front integrator) first appeared on Terragene.

Usage

For routine release of Ethylene Oxide sterilized loads. For routine sterilizer monitoring. For periodic validation of the sterilizer (after installation, repair, relocation).

Applicable regulation

Designed under ISO 13485:2016/NS-EN ISO 13485:2016 Quality Management System standards.

ISO 11140-1:2014, ISO 11138-1:2017, ISO 11138-2:2017.

Authorization

ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM 1614-4.

Classification

Class 1, according to the risk (ANMAT).

Characteristics The kit consists of:

PCD110: PET process challenge system designed to challenge the path and arrival of the sterilizing agent to the Bacillus atrophaeusspore population of a Bionova' BT110 Self-Contained Biological Indicator. On its outer side, the Bionova®' PCD110 process challenge device also contains a Process Indicator that turns orange after exposure.

Process Indicator Initial color: pink Final color: orange

Self-contained Biological Indicator Bionova® BT110 (inside the challenge device): 10⁶ spores of Bacillus atrophaeus ATCC 9372 (ATCC is a registered trademark of American Type Culture Collection) per vial on a paper carrier. Glass ampoule with growth indicator medium. Label with chemical indicator line printed with Ethylene Oxide reactive ink (color change: brown to green).

Final results: fluorescence reading after incubation for 4 hours at 37 °C (sensitivity 97 %). Optionally, visual confirmation of the result (color change of the medium due to pH change) can be performed after 48 hours and seven days of incubation at 37 °C. NOTE: If the sterilization process is unsuccessful, the culture medium will change to yellow during incubation at 37 °C after 48 hours, indicating the presence of live spores. If the sterilization process is successful, the indicator medium will remain blue after incubation.

Environmental conditions during manufacture

T = 15-30 °C, RH = 30-80 %.

Storage conditions

T = 10-30 °C, RH = 30-80 %, keep the product in the original box away from light.

Transport conditions

Storage conditions should be strictly followed. Carry in closed and reinforced boxes in order to avoid damages. The transport of this product does not represent a risk for health.

Shelf life 2 years.

Packing

25 PCD110 + 25 BT110 Biological Indicators per box.

Data on the package:

Product code and description, the process for intended use, presentation, regulation, storage conditions, manufacturer's data, and information on the package label.

Labeling

On the package:

Product code and batch number, the Self-Contained Biological Indicator batch number, manufacturing and expiration dates, regulations, bar code, and datamatrix code.

On the BT110 Self-Contained Biological Indicator:

Label printed with EO reactive ink (turns to green), product code, batch number, expiration date, process for intended use and name of the organism.

Possible target markets

Healthcare, Food, Pharmaceutical and Medical Industries.

Other important information

Read product's instructions for use thoroughly before use.

Precautions

Do not store the product near sterilizing agents.

Do not expose this product to Steam, Dry Heat, Radiation or any other sterilization process than EO.

NOTE: if the lecture was done in 7 days it requires a humidified ambient to prevent the crop getting dry.

The post 4h Ethylene Oxide Sterilization Test Pack PCD Kit first appeared on Terragene.