Monitoring vacuum-assisted Steam Sterilization processes at 121 ºC – 135 ºC and gravity air-displacement Steam Sterilization processes at 121 ºC – 135 ºC.
ISO 11138-1:2006 and ISO 11138-3:2006; IRAM 37102-1:1999 and IRAM 37102-3:1999.
Class 1, according to risk. Authorization Designed under Quality Management System standards ISO 13485:2003/NS-EN ISO 13485:2012. ANMAT (Argentinean National Administration of Drugs, Food and Medical Technology) PM 1614-1.
Polypropylene random copolymer tube: 50.0 mm high x 8.5 mm external diameter. Wall thickness: 0.5 mm Polypropylene microfiber cap at the bottom of the tube. Polypropylene cap: 10.5 mm external diameter, 16.5 mm high. Wall thickness: 1.0 mm Glass ampoule: 35.0 – 38.0 mm high. mm. External diameter: 6.5 mm. Wall thickness: 0.2 – 0.3 mm. Culture medium 0.5 – 0.7 ml, purple color. Cap filter: medical grade paper, 60 g/m2 , 16.0 mm diameter. Spores carrier: psychology-essays.com Filter Paper: 5.0 x 20.0 mm, 160 g/m2 . ≥ 106 Geobacillus stearothermophilus ATCC 7953 spores per vial. Final fluorescence reading is performed after 3 hour-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 3 hour-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 135ºC. Z-Value: Not lower than 6 ºCLeave a reply →