Product Description Rev. 1 | Date: 03-2021 Infection Control Division | Biological Indicators Usage Monitoring Dry Heat sterilization process. Compatible with extremely high temperatures generated during depyrogenation cycles and sterilization processes in ovens and dry heat tunnels. Applicable regulation Designed under Quality Management System standards ISO 13485:2016/NS-EN ISO 13485:2016. Authorization ANMAT (Argentinean National Administration of Drugs, Food and Medical Devices) PM 1614-1. Classification Class 1, according to risk (ANMAT). Characteristics Glass ampoule. 10.2 mm internal diameter. Wall thickness of 0.5 mm. Length: 58.0 mm. > 106Bacillus atrophaeus ATCC 9372 spores per ampoule. Upon completion of the sterilization cycle, the content of the ampoule should be incubated in a suitable culture medium at 37 °C. We suggest the use of Bionova'' MC1030-2 culture medium to final reading in 72 hours. D-ValueoRY is provided: Not lower than 2.0 min. Conditions: 160 °C. Z-ValueDRY is provided: Not lower than 20 °C 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. 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 information: product code and description, process for intended use, regulation, storage conditions, presentation, manufacturer information and data on box's label. Ruta Nac. Ne 9, Km 280, CP 2130, Parque Industrial Micropi, Alvear, Santa Fe, Argentina Tel +54 341 5587007 - [email protected] - www.terragene.com

Product Description Rev. 1 | Date: 03-2021 Infection Control Division | Biological Indicators Labelling On the ampoule: product code, process for intended use, name of organism, batch number, expiration date and trademark. On product's packing: product code, bacterial load, batch number, expiration date, barcode and datamatrix code. Possible target markets Healthcare and Industry. Other important information It is advisable to incubate the content of BT31 in MC1030-2 culture medium at 37 °C using Bionova1, IC10/20 incubators. Read product's instructions for use thoroughly before use. Precautions...

Description de producto Rev. 1 | Fecha: 03-2021 Division Control de Infecciones | Indicadores Biologicos Uso previsto Control de procesos de esterilizacion por Calor Seco. Compatible con temperaturas extremadamente altas generadas durante los ciclos de depirogenizacion y procesos de esterilizacion en homos y tuneles de Calor Seco. Normativa aplicable Diseiiado bajo normas de Sistema de Gestion de Calidad ISO 13485:2016/NS-EN ISO 13485:2016. Clasificacion Clase 1, de acuerdo al riesgo (ANMAT). Caracteristicas Ampolla de vidrio. Diametro interno de 10,2 mm. Pared de 0,5 mm de espesor. Longitud:...

Description de producto Rev. 1 | Fecha: 03-2021 Division Control de Infecciones | Indicadores Biologicos Informacion en el envase: codigo y descripcion del producto, proceso para el cual se utiliza, presentacion, normativa aplicable, condiciones de almacenamiento e informacion del fabricante. Etiquetado Sobre la ampolla: codigo del producto, proceso para el cual se utiliza, lote, fecha de vencimiento, nombre del organismo y marca. En el envase: codigo del producto, poblacion bacteriana, lote, fecha de vencimiento, codigo de barras y codigo datamatrix. Posibles mercados de destino Salud e Industria....