Failure to monitor and record temperatures accurately can mean
that health professionals may be unaware of these potential effects
on medicines, and of course their recipients.
In the UK, warehouses for storing pharmaceutical products need
to comply with MHRA (Medicines & Healthcare Products Regulatory
Agency) regulations concerning temperature control. The regulations
require that "medicines are… consistently stored, transported and
handled under suitable conditions, as required by the marketing
authorisation or product specification."1 This may well
include the monitoring and control of ambient as well as chilled
European Good Distribution Practice (GDP)
Good Distribution Practice Guidelines2 came into
operation in September 2013. Good Manufacturing Practice (GMP) and
GDP relate to quality assurance for medicines in the European
Economic Area (EEA). These activities are coordinated by the
European Medicines Agency and the principles and Guidelines are
mandatory within the EEA.
GDP ensures that the level of quality determined by GMP is
maintained throughout the distribution network, so that medicines
are distributed without any alteration of their properties. A
quality system requires, amongst other standards, that "storage
conditions are observed at all times."
The Guidelines require that suitable equipment and procedures
are in place to check the environment where medicinal products are
stored, taking into consideration factors such as temperature and
relative humidity. After an initial temperature mapping exercise,
monitoring equipment should be located accordingly, particularly in
areas that are shown to experience fluctuations or extremes of
temperature. Even for smaller premises which are at room
temperature, consideration should be given to potential risks such
as heaters, and temperature monitors placed as required.
Alarms should be in place to alert to any deviations from
predefined conditions. Equipment used to control or to monitor the
environment where the medicinal products are stored should also be
calibrated at defined intervals.
GDP also specifies that the correct temperature conditions are
maintained during transportation. There should be a means of
demonstrating and investigating the conditions medicines have been
exposed to, and if requested, information should be available for
review to demonstrate that the correct temperature/RH storage
conditions have been maintained.
The World Health Organisation (WHO) also has specific guidelines
for good storage practice for pharmaceuticals, stating "Where
special storage conditions are required on the label (e.g.
temperature, relative humidity), these should be provided, checked,
monitored and recorded." It recommends that pharmaceuticals stored
in ambient conditions in dry, well-ventilated premises, should be
kept at temperatures of 15-25°C.
WHO Guidelines also cover transportation, recommending that
devices to monitor conditions such as temperature are used where
The WHO goes on to recommend that recorded temperature
monitoring data should be available for review and records kept.
Like the European GDP Guidelines, it recommends temperature mapping
and regular calibration of monitoring equipment.
Vaccines require very specific storage conditions. In general,
the WHO stipulates that vaccines should be stored according to the
manufacturers' recommended temperature range until the point of
administration. This is typically +2 to +8°C, however temperature
ranges may vary, and be very specific, for different types of
The WHO states that "In all countries, systems of refrigeration,
temperature monitoring and record keeping are required to make sure
that each vial of vaccine is maintained under appropriate
Using data loggers for temperature/RH monitoring of
Tinytag data loggers can help satisfy the requirements of
European GDP to provide suitable temperature and relative humidity
monitoring for stored pharmaceuticals and other sensitive medical
Tinytags are accurate and able to measure small changes in
temperature/RH, and loggers with external probes are available to
provide monitoring in hard to reach areas or fridges. Loggers can
be easily moved to different locations, or more units added over
time to build profiles throughout a site, or as premises or the
area to be monitored expand.
Tinytag Explorer software presents the
recorded results clearly and in detail, and allows data from
different logging runs to be combined for comparison and analysis.
Data is presented initially in graphs and tables which can easily
be printed, copied and pasted, or exported into popular software
Setting up the system
In terms of setting up a data logging system according to
European GDP, this will be a two part process.
The first stage will be to temperature map the storage area(s).
This mapping enables risk areas to be pinpointed, which will be the
places in which ongoing temperature monitoring points (stage two)
will be positioned. Mapping should take into account seasonal
variations: for most climates this will necessitate both a winter
and a summer study. Secondly, mapping should include locations
which are likely to have a higher or lower temperature, for
example, loading bays, near heaters, doors, windows, the south side
of a building (north side in southern hemisphere). The mapping will
be carried out before the storage facility is brought online, and
any significant changes that are made as a result of analysing
mapping data will require the mapping exercise to be repeated.
The best practice for a mapping study duration is two weeks,
including a weekend to account for differences in building use and
HVAC system programming.
Having identified the warmest and coldest spots from the
mapping, the second stage will be to install permanent temperature
logging at the risk spots. The number of logging points the
installed system has will vary, depending on the amount of risk
points identified by the temperature mapping and the general layout
and size of the facility. As an indication, big warehouses may
require up to 100 monitoring points
Choosing the right data logger
Initial warehouse temperature mapping may require a large number
of loggers for a short period of time only. A basic entry level
logger, such as the Tinytag Transit 2 for
example, is ideal for this. Loggers can be left to record in
particular areas then moved as required, and the recorded data used
to provide an overall profile of environmental conditions
throughout a facility.
For smaller facilities or areas, standalone loggers can also be
used for all or part of the permanent monitoring solution. They are
robust and reliable, and their battery life means they can be left
to record for long periods if required.
Part of a good system (and in order to pass any GDP inspections
from the regional Health Authority inspectorate) is to have an
appropriate alarm system (and procedures for managing
alarms/temperature excursions). Standalone Tinytags provide the
necessary alarm warnings if conditions fall outside the pre-defined
range. Alarms are indicated by a red flashing LED on the logger, or
an audible alarm box which is available for some models. The
Tinytag View 2
logger has a digital display which includes an alarm icon.
The Tinytag Radio Data Logging System is
well suited to stage two permanent monitoring of pharmaceutical
warehouses. It is ideal for larger premises with multiple
monitoring points, or those requiring immediate central access to
readings, as well as logging over time. Radio loggers gather data
automatically and send it using wireless communications via a
receiver for viewing on a PC, across a LAN, or remotely across the
Radio loggers can be left to record in inaccessible areas or at
height, for example, without having to physically access them to
download data. A mains powered option is also available if
required. Logger quantities and their positions can easily be
changed due to expansion of facilities/re-mapping following other
changes. In terms of the requirement for alarm warnings, if
conditions fall outside the predefined range, notifications appear
in the software. Alarm warnings can also be sent via email or SMS,
enabling corrective action to be initiated.
The WHO and European GDP guidelines recommend regular
calibration checks for temperature monitoring equipment. Gemini
Data Loggers offers a calibration
service for Tinytags with certificates traceable to national
standards. Calibration can be purchased at the time of order, and
loggers can be returned for a service calibration for a standard
charge at any time.