Product Code TCI 013
Description
The Class 5 Chemical Indicator for Steam Sterilization, Unique Point, provides a reliable and efficient means of verifying the effectiveness of autoclave sterilization processes. It is designed to react to all the critical parameters of steam sterilization: time, temperature, and steam quality. It is thus a strong process monitoring tool in laboratories, pharmaceuticals, and healthcare institutes. Each is made with a unique mixture of thermochemical ink that changes color in a distinct and irreversible way when the sterilization conditions are sufficient. This colour transition gives an immediate and easily understandable indication that the load has reached the desired sterilization parameters, removing uncertainty and ensuring the reliability of the process.
Being a Class 5 integrator, this indicator’s performance is very close to that of biological indicators, and thus it is of the highest value for routine monitoring, load release, and process validation. The company maintains the highest degree of precision, consistency, and safety with every indicator through its manufacture under ISO 13485:2016, ISO 9001:2015, and ISO 11133:2014 certified systems in accordance with GMP. Advanced formulation in combination with strict quality control has positioned TM Media’s Class 5 chemical indicator as a trusted means for providing real and reproducible verification of sterilization. It is perfect for pharmaceutical, medical, and research applications where sterility assurance is crucial.
Principle
The Unique Point Chemical Indicator, Class 5 is a precise Chemical Indicator that is used to confirm the effectiveness of steam sterilization, or autoclaving, cycles. It provides an immediate and distinct colour change when all critical sterilization parameters—time, temperature, and steam—are achieved. Manufactured under ISO 13485:2016, ISO 9001:2015, ISO 11133:2014, and GMP-certified quality systems, this Class 5 indicator provides consistent, repeatable, and traceable sterilization validation for pharmaceutical, healthcare, and biotechnology industries.
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