Product Description
250/bg
Terragene IT26-C” title=”Steam Chemical Integrator,
250/bg
Terragene IT26-C” />Steam Chemical Integrator,
250/bg
Terragene IT26-C
UsageControl of Steam sterilization processes between 118 °C and 138 °C.Applicable RegulationDesigned under Quality Management Systems standards ISO13485:2016/NS-EN ISO 13485:2016.ISO 11140-1:2014ClassificationClass 1, according to risk.AuthorizationANMAT (Argentinean National Administration of Drugs, Food andMedical Devices) PM 1614-4.FDA 510(k)K191021CharacteristicsType 5 Integrating Indicator (according to ISO 11140-1).Size: 52 mm x 21 mm.Chemical Integrator consists of a paper wick and a steam andtemperature sensitive chemical pellet contained in a paper/film/foillaminate. The chemical pellet melts and migrates as a dark bar alongthe paper wick. The migration is visible through a zone markedACCEPT or REJECT, thus indicating whether sterilization conditionswere met. The extent of migration depends on steam quality, time, andtemperature. The ACCEPT result is reached when a theoretical sporepopulation reaches its kill time, indicating integration condition hasbeen reached. This condition is calibrated with the kill time of 106Geobacillus stearothermophilus spore population, calculated in BIER(Biological Indicator Evaluator Resistometer).Conditions: saturated steam at 121 °C, 128 °C, 135 °C.Environmental conditions during manufactureT= 15-30 °C, RH = 30-80 %.Storage conditionsT= 10-30 °C, RH = 30-80 %, keep out of direct light.Transport conditionsStorage 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 life5 years.Packing100 or 250 units per aluminum foil bag.
