Usage

Monitoring Ethylene Oxide Sterilization Processes.

4 Hour rapid read. 

FDA 510(k)

K191021

 

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: 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 microfibers on spore carrier, 17.0 mm diameter.
Spore carrier: filter paper, 16.0 mm diameter.
≥ 106 Bacillus atrophaeus ATCC 9372 spores per vial.
 

Final fluorescence reading is performed after 4 hour-incubation at 37 °C (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 37 oC, thus showing the presence of living spores. If sterilization process is successful culture medium will remain blue after the incubation process.
7-day readout for visual confirmation by color change is optional and not intended to be routinely performed; it is an initial validation of the 4 hour-reading. Fluorescence results may be compared to the 7-day visual reading.

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Storage conditions

T= 10-30 oC, RH 30-80 %, keep in the dark place in its original box.

 

The transport of this product does not represent any risk for human health.

 

Shelf life

2 years.

 

Packing

50 units per box.
Packing information: product code and description, process for intended use, presentation, regulation, bacterial strain, storage conditions, manufacturer information and data on pack ́s label.

 

Labelling

On product: 17.0 mm x 33.0 mm polypropylene label. Chemical indicator line, printed with EO reactive ink (Color change to green). Graph showing final fluorescence reading time, product code, batch number, expiration date, process for intended use and name of organism printed in black.

On product’s pack: product code and description, batch number, bacterial load, manufacture and expiration date, barcode and datamatrix code.