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Signatrol’s
range of SL150 temperature data loggers, running the Tempit-Pro
and Tempit HS software packages, can now be configured to compute
and record Mean Kinetic Temperature (MKT). It is widely recognised
that MKT gives a far more representative picture of the effects
of temperature changes on sensitive
materials such as pharmaceuticals and food products during storage
and distribution. It can be shown that the ‘shelf life’
of sensitive materials is directly related to the MKT.
MKT,as
defined by the United States Pharmacopoeia (USP), is a “single
calculated temperature at which the total amount of degradation
over a particular period is equal to the sum of the individual degradations
that would occur at various temperatures” In non-technical
terms, the MKT converts a variable temperature into an equivalent
steady temperature, which is then used to determine the effect of
the excursion on product quality. For example, Pharmacopoeia’s
recommendations for "controlled room temperature," define
that the temperature should be maintained between 15°C and 30°C,
with a mean kinetic temperature less than 25°C. The calculation
gives increased weighting to higher temperature excursions than
normal arithmetic methods, recognising the accelerated rate of thermal
degradation of materials at higher temperatures.
The
SL150 series of temperature loggers are specifically designed to
travel directly with goods and provide a detailed date and time
temperature profile that can be used to highlight any problems.
The data loggers are housed in a fully weld sealed crevice free,
robust food grade polystyrene tags only 10mm thick and are the only
loggers approved by the Royal Institute of Public Health.
The
tags use a patented induction technique for set up and data down
load. As a result there are no plugs, sockets or entries of any
kind thereby avoiding potential ‘bug traps’ and ensuring
total sealing. Powered by an internal battery, the units can be
selected to log at intervals from 30 seconds up to 100 hours and
have a measurement range from -30ºC to +60ºC. With an
internal capacity of 16000 readings, the unit can keep recording
for more than four years! The ‘delayed start’ feature
can be set to coincide with the start of a particular travel schedule.
The
MKT software is available as a free upgrade to registered users
of the Tempit Pro and HS software. As Signatrol’s MD Brian
Turner concludes: “ Users could calculate MKT themselves from
the standard data using the Arrhenius equation. However it’s
far quicker and safer to use our ready made calculator in the software.
All the user has to do is enter the activation energy during set
up (this can vary from 42-125 kJ/mol) and this can be determined
by differential scanning calorimetry.
MKT
= (-DH/R)/Ln{(SUM(exp(-DH/R*Tn))))/n}
where
DH is the activation energy, R the universal Gas Constant (.0083144
kJ/molK), T is the temperature in Deg K, and n the total number
of equal time periods over which data are collected., Ln the natural
log, exp the natural log base and SUM is the total over n periods.
The
following data loggers can be used to measure MKT:
For
more information - click
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