Steam Chemical Integrator, 250/bg , Terragene IT26-C

Steam Chemical Integrator, 250/bg , Terragene IT26-C

Usage Control of Steam sterilization processes between 118 °C and 138 °C. Applicable Regulation Designed under Quality Management Systems standards ISO 13485:2016/NS-EN ISO 13485:2016. ISO 11140-1:2014 Classification Class 1, according to risk. Authorization ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM 1614-4. FDA 510(k) K191021 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. Environmental conditions during manufacture T= 15-30 °C, RH = 30-80 %. Storage conditions T= 10-30 °C, RH = 30-80 %, keep out of direct light. Transport conditions Storage conditions should be strictly followed. Transport in closed and reinforced boxes in order to avoid damages. The transport of this product does not represent a risk for health. Shelf life 5 years. Packing 100 or 250 units per aluminum foil bag.