Terragene 48H Biological Indicator for Room Disinfection with Aerosolized H2O2

Usage
Monitoring of airborne and surface disinfection processes by Hydrogen Peroxide (H2O2).
Applicable regulation
Designed under Quality Management System standards
ISO 13485:2016/NS-EN ISO 13485:2016.
Classification
Class 1, according to risk.
Authorization
ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM 1614-1.
Characteristics
Tubes A and B: polypropylene, 45.0 mm high x 8.5 mm external diameter. Wall thickness: 0.5 mm
Cap A: polypropylene, 10.5 mm external diameter, 13.0 mm high Wall thickness: 1.0 mm. This cap contains a 28.0 mm stem with a slot in which the carrier is located.
Cap B: polypropylene, 10.0 mm external diameter, 16.5 mm high. Wall thickness: 1.0 mm.
Cap filter: polyethylene fibers, 160 g/m2 , 17 mm in diameter.
Glass ampoule: 38.0 - 40.0 mm height. External diameter: 6.5 mm. Wall 0.2 - 0.3 mm thick.
Culture medium 0.65 - 0.75 ml, purple color.
Carrier in tube A: stainless steel 4.9 mm x 15.0 mm x 0.8 mm.
≥ 104 Geobacillus stearothermophilus ATCC 7953 spores per vial.
Upon completion of the disinfection process, incubate the indicator for a maximum of 48 hours at temperature between 55-62 °C.
If disinfection process has not been successful, culture medium will change to yellow during incubation, thus showing the presence of living spores. If disinfection process is successful culture medium will remain purple after the incubation process.
Environmental conditions during manufacture
T =15-30 ºC, RH =30-80 %. Sterility conditions are only necessary during the inoculation and manufacturing process, which is performed in laminar flow.
Storage conditions
T =10-30 ºC, RH =30-80 %, keep in the dark place in its original box.
Transport conditions
Storage conditions should be strictly followed.
Products should be transported in closed and reinforced boxes in order to avoid damages. The transport of this product does not represent any risk for human health.
Shelf life
2 years
Packing
50 units per box. 25 tubes A + 25 tubes B.
Packing information: product code and description, process for intended use, presentation, regulation, bacterial strain, manufacturer information and data on pack´s label.
Labelling
On product: 17.0 mm x 33.0 mm polypropylene label on each tube. On tube A: product code, batch number, process for intended use and name of organism printed in black. On tube B: product code, batch number, process for intended use and a chemical indicator line printed with Hydrogen Peroxide reactive ink, which turns to green after exposure.
On product’s packing: product code and description, batch number, bacterial population, manufacture and expiration date, bar code and datamatrix code.
NOTE: manufacture date is calculated by subtracting 24 months to the expiration date.
Possible target markets
Healthcare and Industry.
Other important information
It is advisable to incubate at 60 ºC in Bionova® IC10/20 auto-reader incubators.
Read product’s instructions for use thoroughly before use.