Product Code TBI 006
Description
Geobacillus stearothermophilus 10⁶ (Vol. 2 ml) Biological Indicator is used widely to validate the efficiency of moist heat sterilization (autoclaving) cycles applied in pharmaceutical, healthcare, and biotechnology industries. One 2 ml ampoule contains 10⁶ viable spores of Geobacillus stearothermophilus ATCC 7953 – a thermophilic bacterium very resistant to steam sterilization-and is the preferred choice for the validation of sterilizer performance and process control.
Manufactured under quality management systems certified to ISO 13485:2016 and ISO 9001:2015, TM Media ensures consistency in manufacturing, product traceability, and sterility assurance. ISO 11133:2014-compliant processes and compliance with GMP further confirm the reliability and reproducibility of each batch.
During validation, the Biological Indicator is positioned inside the load and subjected to steam at 121°C–134°C. At the end of sterilization, it is incubated at 55°C–60°C; absence of turbidity or colour change after incubation would indicate successful sterilization, while evidence of growth indicates an incomplete process.
Engineered with precision and supported by certified quality systems, TM Media’s reliable G. stearothermophilus 10⁶ Biological Indicator (Vol. 2 ml) gives dependable results for sterilizer qualification, process validation, and routine monitoring, assuring confidence in every sterilization cycle.
Principle
Geobacillus stearothermophilus 10⁶ (Vol. 2 ml) Biological Indicator guarantees accurate validation of steam sterilization (autoclave) processes. Each ampoule contains a standardized spore population of G. stearothermophilus ATCC 7953, known for its resistance to moist heat. Manufactured under ISO 13485:2016, ISO 9001:2015, ISO 11133:2014, and GMP-certified quality systems, this indicator guarantees reliability, traceability, and performance consistency in sterilization monitoring.
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