Companies in the health and pharmaceutical sectors are held to strict
standards across various aspects of their operations. Compliance with these
mandatory regulations, also known as GxP regulations, is important for
continued operations – failure to do so would not only result in heavy
penalties but also damage the company’s reputation in the market.
Product quality is maintained in the health and pharmaceutical
industries by ensuring optimal temperature levels throughout production,
storage, transit and transportation. Temperature mapping has emerged as a
popular method for organisations to monitor and log conditions in rooms
where GxP regulations dictate carefully controlled climates.
Biopharmaceuticals are occupying a larger space in the health industry,
requiring companies to allocate higher budgets towards temperature monitoring. Cold
chain storage temperature monitoring currently represents roughly 19 per cent
of the industry’s expenditure on storing medicines, which equates to around
$12.6 billion worldwide, according to Pharmaceutical Commerce’s 2016
Sourcebook. This is expected to rise to 22 per cent by 2020.
With regulatory authorities keeping a close watch, pharmaceutical
manufacturers are increasingly relying on temperature monitoring equipment to
store accurate logs that can be used to prove compliance to auditors.
The first step to creating a controlled climate is to map the storage area
– companies need to identify warm zones, entrances and exits affecting
temperatures, and other deficiencies commonly found in cold chain storage.
Creating cold chain efficiency
Companies will commonly utilise temperature monitors over a period of
time to evaluate their effectiveness and prevent system failures from going
unnoticed. These monitors have proven to be valuable tools in mapping
temperature loss in warehouses, as well as cold chain storage.
For the sake of accuracy, organisations follow the regulatory rule that
these devices should be calibrated within three points of the range
of temperature that a biopharmaceutical is stored, according to PharmOut. Organisations
are also advised to calibrate their monitoring devices every year following a
validation of their temperature mapping strategy and tools.
The validation process will ensure that the mapping process didn’t miss
anything, and temperature monitoring devices won’t malfunction.
In such a competitive industry, having one regulatory infraction can be
catastrophic for a company’s reputation, finances and even existence. Businesses
must necessarily go beyond simply monitoring the temperatures in their storage
facilities by mapping and consistently calibrating and validating the
technology responsible for temperature monitoring.