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

FDA cleared

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 106 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 Extender – Chemical Integrator for Steam first appeared on Terragene.

FDA cleared

Integron® IT12 Chemical Integrators (Type 5 according to ISO 11140-1:2014 standard) are single-use two level chemical indicators that consist of paper strips laminated on the back side and printed with indicator ink.

They have been designed for monitoring Ethylene Oxide (EO) sterilization processes. The integration level contains a purple/brown ink which was developed to turn to green when a theoretical spore population reaches its kill time, thus indicating that the SAFE condition has been met.

Level 1 - Red: Exposure level. Indicator ink turns yellow to indicate exposition to the process, but does not ensure that the variables required to achieve the integration condition have been achieved (UNSAFE condition).

Level 2 - Purple / brown: Integration level. Indicator ink turns green to indicate that the integration condition indicated in the quality certificate has been achieved. This condition consists of the kill time of a theoretical 10^6 Bacillus atrophaeus spore population, calculated in a BIER (Biological Indicator Evaluator Resistometer), and is called SAFE condition. Indicators 100% free of toxic heavy metals.

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

Instructions for Use

1. Place a Integron® IT12 Chemical Integrator along with the material to be sterilized in a suitable package according to the recommended sterilization techniques. Place the indicators in those areas of most difficult access to the sterilizing agent.

2. Perform the sterilization cycle.

3. After the sterilization process has finished and evacuation/ventilation process is over, you may:

A. Remove the integrator indicator taking the necessary precaution to avoid contact with the remaining sterilizing agent.

B. Ventilate the load together with the integrator indicator and then perform the reading.

4. Analyze the results. If the SAFE integration condition has been reached, the sterilization process has been effective.

The post Chemical Integrator for EtO first appeared on Terragene.