Self-contained Biological Indicator for Formaldehyde sterilization processes

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Monitoring Formaldehyde Sterilization Processes.
Applicable Regulation
ISO 11138-1:2006 and ISO 11138-5:2006; IRAM 37102-1:1999.
Class 1, according to risk.
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: 45.2 mm high x 8.5 mm
external diameter. Wall thickness: 0.5 mm.
Polypropylene cap: 10.6 mm external diameter, 13.0 mm high. Wall
thickness: 0.9 mm.
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.
Cap filter: medical grade paper, 60 g/m2
, 17.0 mm diameter.
Polyethylene fibers: 7.0 mm diameter.
105 or 106 Geobacillus stearothermophilus ATCC 7953 spores per vial.
Positive growth results (failure in the sterilization process): culture
medium turns to yellow, incubation at 60 ºC for 48 hours (maximum).
D-ValueFORM: not lower than 6 minutes at 60 ºC, 1 mol/l Formaldehyde


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