Introduction
Economic pressures demand that operational inefficiencies be addressed and the highly regulated pharmaceutical industry is no exception. In past years, the need to ensure accuracy of measurement and documentation of data superseded any cost/time cutting methods. Inherent sources of inaccuracy had to be offset as best as possible, despite long, time-consuming methods meant to maintain accuracy and verify results. Thermal validation is a perfect example of this, with pre- and post calibration being de rigueur in mapping projects.
However, as improved technologies emerge, calibration of measurement devices is one area that can be made more efficient. Typical calibration protocols specify pre- and post-calibrations. But, much of the associated expenditures in time and labor in thermal validation can be greatly reduced if the right tool is used.
A more efficient approach to temperature mapping is to look at the temperature range to be mapped and use the most suitable instrument for that range, which allows pre- and post-calibration steps to be entirely eliminated. Thermocouples are the traditional tool for mapping projects, but require pre- and post-cal. Thermistor-based devices are quickly becoming the preferred tool for temperature mapping because—used in moderate-range temperatures—they are a more stable, accurate sensor and do not require pre- and post-calibration. However, pre- and post-cal is not the only problem with using thermocouples. Handling and placing the wires is time-consuming and labor intensive and is the direct cause of some major sources of error.
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