Usage

Monitoring plasma or vaporized Hydrogen Peroxide sterilization processes (VH2O2).

Applicable regulation

Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016.

ISO 11138-1:2017 and IRAM 37102-1:1999.

FDA 510(k) K191021

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Characteristics

Polypropylene tube: 50.4 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: polyethylene fibers. 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 microfibers on spore carrier: 17.0 mm of diameter. Spore carrier: polyethylene fibers, 17.0 mm of diameter.

≥ 10-6 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 performed after 48 hours of incubation. If sterilization process has not been successful, culture medium will change 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 prevent medium from drying out.