Terragene Biological Indicator Self Contained Spore Ampoiles

Usage
Monitoring industrial Steam sterilization processes of liquids between 121 °C - 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.
Classification
Class 1, according to risk.
Authorization
ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM 1614-1.
Characteristics
Glass ampoule. 10.2 mm internal diameter. Wall thickness of 0.5 mm.
Length: 58.0 mm.
Culture medium 2.0 ml, purple color.
106 G. stearothermophilus ATCC 7953 spores per ampoule.
Incubation conditions: 48 hours (maximum), between 55 - 62 °C.
Culture medium turns to yellow due to bacterial growth.
D-Value ≥ 1.5 minutes at 121 ºC. Another D-value is declared 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= 2-8 °C (in refrigerator), RH= 30-80 %, keep out of direct light.
Storage at T≤ 25 °C is possible for a period no longer than 15 days.
Transport conditions
Storage conditions should be strictly followed.
Transport in closed reinforced boxes to avoid damage.
The transport of this product does not represent a risk for health.
Ampoules can be stored at temperature below 25 °C for up to 15 days during transportation.
Shelf life
2 years.
Packing
50 units + 5 negative controls per box.
Packing information: product description, process for intended use, regulation, storage conditions, presentation, manufacturer information and data on box´s label.
Labelling
On product’s packing: product code and description, bacterial strain and load, batch number, manufacture and expiration date, bar code and datamatrix code.
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 instrictions for use thoroughly before use.