TEMPERATURE MAPPING.
The Requirement for Temperature Mapping.When regulatory controlled product is being manufactured, and heat processing is involved (heating or cooling), the individual Operational Qualification (OQ) of the equipment in use (i.e. mixers, ovens, freezers, hot rooms, cold rooms, sterilizers) must call for heat distribution studies of the product containment area, to ensure that the required temperature has been attained and that it is uniformly applied to all of the product throughout the process. Rooms would be scaled similarly, with one sensor in each corner and one high layer and one lower layer, giving a total in a smaller room of eight sensors. TEMPERATURE LOGGING EQUIPMENT.
Double Click on Either Graphic for Full Technical Specifications.The use of individual self contained data loggers that measure 1.06" x 3.7" (27mm x 94mm) and have the capacity to log 16,382 temperature points, makes this a simple task. Logging at one record every 12 minutes gives a time scale of generating records continuosly for over 200 days, or 45 hours at one every 10 seconds. The data loggers listed below are used by ourselves and represent a quantum leap from the troublesome and very expensive, chart recorder days. It is really so simple to place the individual data loggers in place with no power or instrument wiring to obstruct everyday activities in the area. In fact the operators really do not notice that temperature mapping is taking place. At the end of the data logging exercise, the individual loggers are plugged straight into the laptop USB port, and the raw data down loaded. Since this is test equipment where the data is printed out, reviewed and approved as hard copy, 21CFR Part 11 does not apply. 
Data logger configuration software is supplied, allowing the user to easily set-up the data logger. Selectable parameters include logging rate, measurement units, high & low alarms and start-time. The logged data stored in USB-Data Logger is downloaded via the configuration software. Once downloaded, data can be graphed, printed, or exported to other applications. The data logger configuration software is compatible with Windows 98/2000/XP. SIMPLE REGULATORY COMPLIANCE.The introduction of these self contained data loggers has transformed the task of temperature mapping. No longer do you have to pull fridges, freezers, cold or hot rooms out of service, to temperature map them, no longer do you have to fit expensive chart recorders to obtain process records, no longer do you have to drill and fabricate bracket for recorders, sensors and power supplies. Just open the door and position a data logger among the load. For Operational Qualification, locate several (depending on volume to be logged) data loggers in the product area along with the product and preferably during routine production. For product records maintain one data logger permanently in the product area. Schedule the data longer for down loading every batch / month / quarter / year. Schedule the data logger for an annual battery change (it will not lose its records due to a flat battery or during battery change). The software is equally easy to use and comes free, with the data logger.
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