Chemical Integrator for Steam (FDA)

IT26-C / Moving front Chemical Integrator to monitor Steam sterilization processes between 118°C and 138°C.

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

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.

NOTE: In some extended or wet steam cycles, the dark bar can display discoloration in some zones of the reading window, imposing a difficulty for result´s interpretation (see Result Reference Guide for reference).

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.