Terragene Bionova Biological Indicator BT20/6 (30) SCBI for Steam Sterilization Process 1pack(30pcs)

Usage
Monitoring vacuum-assisted and gravity air-displacement Steam Sterilization processes at 121-135 °C.
Applicable regulation
Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016.
ISO 11138-1:2017 and ISO 11138-3:2017; IRAM 37102-1:1999 and IRAM 37102-3:1999.
Authorization
ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM 1614-1.
Classification
Class 1, according to risk (ANMAT).
Characteristics
Polypropylene tube: 45.2 mm high x 8.5 mm external diameter. Wall thickness: 0.5 mm.
Polypropylene cap: 13.0 mm high x 10.9 mm external diameter. Wall thickness: 0.7 mm.
Cap filter: medical grade paper, 17.0 mm diameter.
Glass ampoule: 35.0 - 40.0 mm high. External diameter: 6.5 mm. Wall thickness: 0.2 – 0.3 mm.
Culture medium: 0.5 – 0.7 ml, purple color.
Spore carrier: filter paper, 7.0 mm diameter.
105 or 106 Geobacillus stearothermophilus ATCC 7953 spores per vial.
Upon completion of the sterilization cycle, incubate the indicator for a maximum of 24 hours at temperature between 55-62 °C.
Positive growth results (failure in the sterilization process): culture medium turns to yellow after incubation between 55-62 °C for 24 hours (maximum).
D-Value: Not lower than 1.5 minutes at 121 °C. Another D-value is informed at 132 °C and 135 °C.
Z-Value is informed.
Environmental conditions during manufacture
T = 15-30 °C, RH = 30-80 %. Sterility conditions are necessary only during the inoculation process performed in laminar flow.
Storage conditions
T = 10-30 °C, RH = 30-80 %, keep in a dark place in its original box.
Transport conditions
Storage conditions should be strictly followed.
Transport in closed and reinforced boxes in order to avoid damages.
The ransport of this product does not represent any risk for human health.
Shelf life
2 years.
Packing
30 units or 100 units per box.
Packing information: product code and description, intended use, presentation, regulation, bacterial strain, storage conditions, manufacturer information and data on box´s label.
Labelling
On product: 17.0 mm x 33.0 mm polypropylene label printed in black.
1.5 mm chemical indicator line, printed with Steam reactive ink (color change to brown). Product code, batch number, expiration date,
intended use and name of organism.
On product’s packing: product code, batch number, bacterial load, manufacture and expiration date, barcode 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 °C in Bionova® IC10/20 incubator.
Read product’s instructions for use thoroughly before use.