BT96
Self-Contained Biological Indicator.
Super Rapid Readout Fluorescence System.

Usage
Monitoring plasma or vaporized Hydrogen Peroxide sterilization processes (H2O2).

Applicable Regulation
ISO 11138-1:2006 and IRAM 37102-1:1999.

Classification
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.

Characteristics
Polypropylene tube: 50.5 mm high x 8.5 mm external diameter.
Wall thickness: 0.5 mm
Special filter: 17mm of external diameter polypropylene microfibers.
Polypropylene cap: 10.5 mm external diameter, 16.5 mm high.
Wall thickness: 1.0 mm Glass ampoule: 3.8 – 40.0 mm high. mm.
External diameter: 6.5 mm.
Wall thickness: 0.2 – 0.3 mm.
Culture medium 0.65 – 0.75 ml, purple color.
Cap filter: polyethylene fibers, 160 g/m2 , 16.0 mm diameter.
Polyethylene fibers: 5.0 x 40.0 mm, 160 g/m2 . ≥ 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.
D-Value at 2 mg/l H2O2, 50 ºC.

Environmental conditions during manufacture
Room temperature 15-30ºC, relative humidity 30-80%. Sterility conditions are only necessary during the inoculation and manufacturing process, which is performed in laminar flow.

Storage conditions
Best stored in original box under the next conditions: temperature 10- 30 ºC, relative humidity 30-80 %.

Transportation conditions
Storage conditions should be strictly followed. Products should be transported in closed and reinforced boxes in order to avoid damages. Product transportation does not represent any risk for human health.

Shelf-life
24 months.

Packing
50 units per box.
Packing information: product code and description, process for intended use, presentation, classification according to regulation, manufacturer information and data on box´s label.

NOTE: manufacture date is calculated by subtracting 24 months to the expiration date.

Labelling
On product: 17.0 mm x 33.0 mm polypropylene label. 1.5 mm chemical indicator line, printed with Hydrogen Peroxide reactive ink (color change to green). Graph showing final fluorescence reading time, product code, batch number, process for intended use and bacterial strain printed in black.
On product’s box: product code, batch number, bacterial load, manufacture and expiration date.

Possible target markets
Healthcare and Industry.

Other important information (optional)
It is advisable to incubate at 60 ºC in Bionova® IC10/20FR, IC10/20FR LCD o Mini Bio Auto-Reader incubators. Read product’s directions for use thoroughly before use.

NOTE: When necessary, limits of each product’s parameters should be specified.

Description of identified and/or predictable risks which could represent a risk for the product
Do not store the product near sterilizing agents.
Do not expose this product to Ethylene Oxide, Dry heat, Radiation or any sterilization process other than Hydrogen Peroxide. The positive biological indicator can be autoclaved at 121 ºC for at least 20 minutes, at 132 ºC for at least 15 minutes in gravity displacement Steam sterilization, or at 134 ºC for at least 10 minutes in vacuum Steam sterilizer.