Fluorescence SCBI for Steam (GD), 60°C (30 min), 50/bx , Terragene BT223

Fluorescence SCBI for Steam (GD), 60°C (30 min), 50/bx , Terragene BT223

Usage Monitoring gravity-air displacement Steam sterilization cycles at 132 °C - 135 °C. Applicable regulation Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016. ISO 11138-1:2017 and ISO 11138-3:2017; IRAM 37102-1:1999 and IRAM 37102-3:1999. Classification Class 1, according to risk. Authorization ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM 1614-1. FDA 510(k) K163646 Characteristics Polypropylene tube: 50.7 mm high x 8.5 mm external diameter. Wall thickness: 0.5 mm. Polypropylene cap: 16.4 mm high x 10.7 mm external diameter. Wall thickness: 0.9 mm Cap filter: medical grade paper, 17.0 mm diameter. Glass ampoule: 35.0 - 40.0 mm high. External diameter: 6.8 mm. Wall thickness: 0.2 – 0.3 mm. Culture medium 0.5 – 0.7 ml, purple color. Polypropylene microfiber on spore carrier, 17.0 mm diameter. Spores carrier: filter paper, 16.0 mm diameter. ≥ 106 Geobacillus stearothermophilus ATCC 7953 spores per vial. Final fluorescence reading is performed after 30 minute-incubation at 60 ºC (sensitivity: ≥ 97 %). An optional visual pH color change confirmation could be made after 48 hours of incubation. If sterilization process has not been successful, culture medium will change to a greenish color first, and then to yellow during incubation at 60 ºC, thus showing the presence of living spores. If sterilization process is successful culture medium will remain purple after the incubation process. 7-day readout is optional and not intended to be routinely performed; it is an initial validation of the 30 minute-reading. Fluorescence results may be compared to the 7-day visual reading. NOTE: if 7-day readout is performed, a humidified environment will be required to avoid medium to dry out. D-Value: Not lower than 1.5 minutes at 121 ºC. Another D-value is informed at 132 ºC and at 135 ºC. Z-Value is informed.