Stability testing of pharmaceutical
products is an essential method of determining “shelf life”
(i.e. expiration dates) and storage conditions. A stability
test period can range 6 to-12 months depending on the protocol.
The test period including the temperature and humidity (RH)
conditions are determined based on ICH (International Conference
of Harmonization) guidelines. ICH test conditions can be one
of the following: 25 C / 40% RH, 25 C / 60% RH, 30 C / 65% RH or 40 C / 75% RH.
ICH requires conditional tolerances of +/-2 C and +/- 5% RH.
Stability chambers can be refrigerator size or large “walk-in”
types. Mapping these chambers with a thermocouple based system
is time intensive because the “wires” must be carefully fed
through sealed ports or door seals. Also, separate RH sensor
assemblies must be installed and connected to the system.
Using a thermocouple based system may be the only alternative
if “seeing live data” is important. However, for most chamber
mapping work, using wireless dataloggers is by far the best
alternative.
The XpertLog wireless dataloggers were designed for stability
chamber mappings. The temperature datalogger has a range of
-60 C to 150 C with a calibrated accuracy of +/-0.1 C. The
RH datalogger has a calibrated range of 20% to 90% with an
accuracy of +/- 2%. The XpertLog RH datalogger is uniquely
calibrated for all ICH temperature points*.
*Note: RH measurements vary with temperature so calibration
at specific ICH temperature points are necessary to maintain
accuracy. Most other RH dataloggers are only calibrated at
25 C. If used for 40 C stability studies then a special calibration
is required. Otherwise, the RH measurement error can easily
exceed the ICH limit of +/- 5%.
In summary, the XpertLog dataloggers save considerable time
for stability mapping work. Also, they can be easily used
to monitor the chamber throughout the study. For critical
studies, this can insure that the exposure conditions were
in tolerance throughout the chamber.
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