The Requirement for Temperature Mapping.
regulatory controlled product is being manufactured, and thermal
processing or storage is involved (heating or cooling), the individual Operational
Qualification (OQ) of the equipment in use, must call for heat
distribution studies of the actual product processing or storage
compartment to be undertaken. This study must verify that all
product will be subject to the same thermal environmental conditions;
no matter where the product is situated within the processing
compartment. This verification is mandatory and applies to all
environmental process and storage equipment such as; mixers, ovens,
freezers, hot rooms, cold rooms, sterilizers, warehouses, delivery
vans, transport containers, stability chambers, freeze dryers and
During and after manufacture, the product is often held in storage
areas or warehouses. The environmental conditions in these
facilities are traditionally held to human comfort levels and that is
purely within the physical level; humans are working within.
Large fabricated metal storage warehouses can show enormous variations
in both heat gains and heat losses. They can in certain locations
and certain seasonal times hit highs of plus 60 degrees centigrade and
lows of minus 30 degrees centigrade. This renders it essential to
ensure your validation performance qualification (PQ) verifies that
during these extremes of temperature your product is maintained within
the temperature range specified by the product makers.
distribution studies of large stores and warehouses requires sensors to
be fitted strategically throughout the storage shelving, covering a
percentage of the shelving area horizontally and vertically. A typical layout for a 1000 Square meter (floor
area) warehouse with shelves stacked 4 meters high (giving 4000 cubic
meters of storage area); would be one sensor in each corner of the
storage area, one midway along each wall and one in the center. This means nine sensors would be placed on the
lowest storage shelf, then nine on the middle shelf and finally nine on
the top shelf; a total of 27 sensors.
processing equipment such as; stability
should be scaled similarly, with one sensor
in each corner and one high layer and one lower
layer, giving a total in a smaller volume of eight sensors. With
autoclave it is required to place an additional sensor in or close to
the drain. Do not insert it down the drain, as it will
fail. Remember you are required to demonstrate that
climatic condition are uniform throughout the usable product processing
areas - down the drain is not such an area.
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, 21
CFR 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.