The authorities
that develop standards for Good Manufacturing Practices in the United States,
Canada, European Union, Australia, Japan and China continue to tighten
regulations related to thermal mapping of a warehouse or freezer. This
tightening of regulations has put pressure on companies improve the quality of
their warehouse design and storage layout. Improvements in monitoring
technology has helped enhance standards of practices for thermal mapping,
however, the technology is only as good as the data it produces and the
analysis it provides. Action is needed from data and if companies don't have
the data they need or the right personnel to analyze that data, temperature mapping services are often needed by experienced third parties.
The Process For Temperature Mapping Studies
Mapping takes
into account the temperature and the density of humidity of warehouses for
environmentally sensitive products.
Your facility
and the products you store can determine the length and type of temperature
mapping study that is conducted. In general though, a temperature mapping study
will determine mapping protocols (and procedures) to be adapted to the needs of
your environment, and the required conditions. Generally, temperature mapping
services include the following steps:
1. Creating a Validation Plan - a validation plan and protocol
provides logical and scientific justifications for each step in your process;
each change in the plan should be documented.
2. Identify areas at risk and develop protocol information to
determine where the sensors can be fixed - the most sensitive parts of the
warehouse where the temperature tends to fluctuate must be identified so
sensors can be installed in the right places to eliminate the risk of losing
the product.
3. Select suitable technology - there are many companies that
provide solutions for temperature mapping of freezers and cold warehouses
(Berlinger, Logtag, Infitrak for example), however, it is important to select a
technology that adequately meets the requirements of your particular products.
How it is packaged, stored and transported can determine the type of sensor to
use.
4. Set up mapping equipment and conduct a test for a review -- it
is “a must” to test the equipment that is set up to map the temperature
fluctuations, to see if it meets the desired standards. Calibration is an
essential step to this process.
5. Make modifications, document and schedule the mapping test -- if
/ when necessary modifications have to be made, and if the need for an
amendment becomes apparent, the sooner you find the problem, the lesser chances
of losing your stock.
Following this
process enables you to minimize risk and maximize product safety. If you don't
have the expertise in-house, temperature mapping services can be outsourced to
an experienced provider who not only can map your facility, but calibrate
sensors, write your protocols, and aid you in meeting compliance standards.
