Control of Steam sterilization processes between 118 °C and 138 °C.

FDA cleared

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

Characteristics

Type 5 Integrating Indicator (according to ISO 11140-1).

Size: 52 mm x 21 mm.

Chemical Integrator consists of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark bar along the paper wick. The migration is visible through a zone marked ACCEPT or REJECT, thus indicating whether sterilization conditions were met. The extent of migration depends on steam quality, time, and temperature.

The ACCEPT result is reached when a theoretical spore population reaches its kill time, indicating integration condition has been reached. This condition is calibrated with the kill time of 10^6 Geobacillus stearothermophilus spore population, calculated in BIER (Biological Indicator Evaluator Resistometer). Conditions: saturated steam at 121 °C, 128 °C, 135 °C.

Optionally, the readout of the chemical indicator can be done using Trazanto Automatic Quality Control and Traceability System (see instructions for use in device´s manual).

Instructions for Use

1. Carefully open the package and remove only the number of indicators needed.

Reseal the package tightly.

2. Place a Integron® IT26-C indicator in each pack, peel pouch, container system or tray to be steam sterilized in the most inaccessible area to sterilizing agent.

3. Perform de sterilization cycle.

4. After the sterilization process has finished, the dark bar should have reached the ACCEPT zone. If the dark bar has not reached the ACCEPT zone, a REJECT result is indicated and the items in the pack, peel pouch, container system, or tray were not exposed to proper steam sterilization conditions. These items should be reprocessed according to established procedures and a new IT26-C has to be used.

Despite this, regarding cycle integration parameters, this process can be considered as accepted. In case the IT26-C indicator shows a damp appearance after the sterilization process, Terragene® recommend planning an equipment´s maintenance.

The post IT26-C – Chemical Integrator for Steam first appeared on Terragene.

Bowie-Dick Test Pack is designed for testing air removal efficiency of dynamic-air-removal steam sterilizers operating at 132 °C for 4 minutes and at 134 °C for 3.5 minutes. Please review the instructions for use for applicable cycles in your country

FDA cleared

Characteristics

Type 2 Chemical Indicator

Equivalent in performance to the ANSI/AAMI ST79 Bowie-Dick Towel

Pack.

Detects residual air in the sterilizer chamber due to air leaks, air removal failures or steam quality.

Holds an early warning sheet designed for early detection of air removal failures before they appear on the test sheet.

Initial Color: yellow

Final Color: dark brown/black (should change homogeneously in the

whole sheet)

Size: 16 mm x 125 mm x 113 mm

Assembly: 1 impermeable barrier - 1 Foam - permeable barriers - 1 Glassine paper - 1 Test Sheet - permeable barriers - 1 Glassine paper - 1 Warning Sheet - permeable barriers - 1 impermeable barrier. Wrapped with crepe paper.

Instructions for use

1. Run a warm-up cycle to properly heat the sterilizer.

2. Place the Bowie-Dick Test Pack horizontally with the label facing up in an empty vacuum assisted sterilizer chamber, in the bottom/front of the sterilizer rack and over the drain. The Test Pack should read "THIS SIDE UP" when placed correctly.

3. Run the sterilizer cycle for 3.5 min. - 134 ºC / 4 min. - 132 °C.

4. Remove the test pack from sterilizer and allow it to cool down. Check color change of type 1 indicator on the label.

5. Unwrapped the pack and remove the test and warning sheets. Check them for color change and record the results.

The post Bowie-Dick Test Pack (ISO 11140-5) first appeared on Terragene.

Control of Steam sterilization processes between 121 ºC and 135 ºC.

FDA cleared

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

Characteristics

Type 5 Integrator Indicator (according to ISO 11140-1).

One-side-laminated strips printed with indicator ink.

Size: 70 mm x 23 mm.

Initial color: yellow.

Final color: black.

100 % Toxic Heavy Metal free.

Instructions for use

1. Place a chemical integrator Integron® IT26-1YS within each package, bag or tray that will be sterilized by Steam. In rigid containers place an IT26-1YS in every corner, or at least two diagonally opposite corners, to ensure that steam has reached the most inaccessible areas.

2. Perform the sterilization cycle.

3. After the sterilization process has finished, remove the indicators from the sterilizer and analyze the results. For all the chemical indicators exposed to Steam, the ink must turn to the black reference color when the integration conditions are reached.

The post IT26-1YS Chemical Integrator for Steam 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.