Terragene Spore Coupon Biological Indicator

Usage
Monitoring Plasma or Vaporized Hydrogen Peroxide (H2O2) Sterilization Processes.
Applicable Regulation
Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016.
ISO 11138-1:2017 and IRAM 37102-1:1999.
Classification
Class 1, according to risk.
Authorization
ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM 1614-1.
Characteristics
25 mm x 70 mm non-absorptive material package. Blue code.
Stainless steel coupon 34.0 mm x 7.0 mm x 0.8 mm.
106 Geobacillus stearothermophilus ATCC 7953 spores per coupon.
Upon completion of the sterilization cycle, the spore coupon should be tested in a suitable culture medium. We suggest the use of Bionova®
MC1020-2 culture medium.
Incubation conditions: 24 hours, between 55-62 °C.
For conventional culture media like TSB, incubation for 7 days between 55-62 °C is recommended.
Environmental conditions during manufacture
T= 15-30 ºC, 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 %.
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
100 units per aluminum foil bag.
Labelling
On product’s envelope: product code and description, process for intended use, bacterial strain, batch number, expiration date and datamatrix code.
On product’s packing: product code and description, bacterial strain, process for intended use, bacterial load, batch number, manufacture
date, expiration date, presentation, classification according to regulation, storage conditions, manufacturer information, barcode 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 directions for use thoroughly before use.