Product Description
for Steam (GD), 60°C
(30 min), 50/bx
Terragene BT223″ title=”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
UsageMonitoring gravity-air displacement Steam sterilization cycles at 132 °C -135 °C.Applicable regulationDesigned under Quality Management System standards ISO13485:2016/NS-EN ISO 13485:2016.ISO 11138-1:2017 and ISO 11138-3:2017; IRAM 37102-1:1999 and IRAM37102-3:1999.ClassificationClass 1, according to risk.AuthorizationANMAT (Argentinean National Administration of Drugs, Food and MedicalDevices) PM 1614-1.FDA 510(k)K163646CharacteristicsPolypropylene tube: 50.7 mm high x 8.5 mm external diameter. Wallthickness: 0.5 mm.Polypropylene cap: 16.4 mm high x 10.7 mm external diameter. Wallthickness: 0.9 mmCap filter: medical grade paper, 17.0 mm diameter.Glass ampoule: 35.0 – 40.0 mm high. External diameter: 6.8 mm. Wallthickness: 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 60ºC (sensitivity: ≥ 97 %).An optional visual pH color change confirmation could be made after 48hours of incubation. If sterilization process has not been successful,culture medium will change to a greenish color first, and then to yellowduring incubation at 60 ºC, thus showing the presence of living spores. Ifsterilization process is successful culture medium will remain purple afterthe incubation process.7-day readout is optional and not intended to be routinely performed; it isan initial validation of the 30 minute-reading. Fluorescence results may becompared to the 7-day visual reading.NOTE: if 7-day readout is performed, a humidified environment will berequired to avoid medium to dry out.D-Value: Not lower than 1.5 minutes at 121 ºC. Another D-value isinformed at 132 ºC and at 135 ºC.Z-Value is informed.
