Precision Temperature Measurement Solutions
Medical Indicators, Inc. is a FDA registered and ISO 13485 certified manufacturing facility located in Hamilton, New Jersey producing over 100 million precision temperature measurement solutions per year. Whether it’s NexTemp, TempaDOT or TraxIt, we have a precision thermometer that meets your unique temperature measurement requirements.
Precision Built In
The manufacturing process starts with our patented chemistry system. Each dot on our thermometers contains a unique formulation of chemistry that’s designed to react at a specific temperature. That means for a single thermometer, we have 45 unique Fahrenheit mixtures, 50 unique Celsius mixtures, or 70 unique TraxIt mixtures which have been custom formulated to activate at each specific temperature point.
Every lot of NexTemp, TempaDOT or TraxIt thermometers undergoes a two stage precision accuracy testing process. The first stage of accuracy testing occurs when the thermometers are initially manufactured. Medical Indicators performs random sampling for in-process roll accuracy testing and we test in our calibrated, precision water baths to ensure that their performance meets our rigid Quality Control requirements.
A second accuracy test is performed when the thermometers are packaged. Thermometers are randomly sampled at a 1.5% AQL, based upon lot size, tested in precision water baths which have been customized to meet our stringent accuracy needs. All accuracy results are compared to the requirements of nationally or internationally recognized testing standards (Table 1.) before the thermometers are released for sale.
Table 1. Accuracy requirements of recognized testing Standards
Throughout the manufacturing and packaging processes, trained operators are constantly monitoring the processes to ensure good quality of products that meet customer satisfaction are being produced.
|Critical Range (°F)||Allowable Deviation||Critical Range (°C)||Allowable Deviation|
|ASTM E 1299||98.0 – 102.0 °F||± 0.2 °F||37.0 – 39.0||± 0.1 °C|
|ASTM E 825||98.0 – 102.0 °F||± 0.2 °F||37.0 – 39.0||± 0.1 °C|
|BS EN 12470-2||N/A||N/A||35.5 – 40.4 °C||+ 0.1/- 0.2 °C|