All pharmaceutical products are temperature-sensitive and are subject to strict regulations in order to maintain safety and quality. This means that temperature control is vital for pharmaceutical storage.
Here’s more about why it is so important and how to monitor and control temperature in a pharmaceutical warehouse.
Why Temperature Control is Important for Pharmaceuticals
From medicines to vaccines, biopharmaceuticals to medical devices, these individual products have different chemical compositions. Therefore, even the slightest variation in temperature can impact the chemical stability.
Temperature control is required to ensure medicines are fit for purpose. Compromised efficacy means entire batches can be deemed unusable, leading to significant financial losses and potential health risks.
So much so, the Medicines and Healthcare products Regulatory Agency (MHRA) state that the temperature must be kept below 25°C to avoid pharmaceutical products spoiling.
Meeting Regulatory Requirements
Maintaining consistent temperatures for pharmaceutical products not only affects the integrity of the medicines, but it also ensures regulations and standards are met. There are strict guidelines set by the MHRA around pharmaceutical storage.
This regulatory body inspects facilities that manufacture and carry out safety tests on medicines to ensure they comply with Good Manufacturing Practice and Good Laboratory Practice standards, among other activities. If these standards are not met, this can lead to fines, sanctions or loss of licenses.
Methods to Control Temperature in Pharmaceutical Industry
Temperature Monitoring
First of all, it’s important for pharmaceutical warehouses to monitor the temperatures regularly to make sure medicines are stored at the right temperatures. This way, any problems or issues can be identified and rectified quickly to avoid harmful temperature variations.
At EcoCooling, we provide a number of control systems, like the CREC, system which provides thermostats and humidstats to measure the temperature and humidity levels in pharmaceutical warehouses. With the ability to connect to external alarms and communication systems, you can be alerted to any deviations and make sure the system returns to optimal conditions.
Incubator & Controlled Ambient Storage
When testing pharmaceutical products, an ambient temperature is usually required to ensure stability and efficacy. For temperatures between 15 – 60°C, incubator stores, hot boxes and controlled room temperature (CRT) systems are used for closely monitoring products and keeping them at an optimum temperature level.
Frozen & Ultra-Low Storage
On the other end of the spectrum, some pharmaceutical products, like vaccines and large volumes of samples, require storage to be kept at temperatures between -70 – 0°C. This is where frozen storage and ultra-low storage can help maintain these temperatures, particularly for long periods of time.
Pharmaceutical Cooling Systems
Pharmaceutical cooling systems are a reliable compliance solution that are more cost-effective than refrigeration. Our pharmaceutical evaporative cooling and ventilation systems can help uphold MHRA standards even during elevated temperatures. By using water evaporation to maintain temperature limits, you can make sure product integrity is guaranteed and regulatory standards are met.
For your pharmaceutical storage cooling, come to EcoCooling. Read about our pharmaceutical case studies here or get in touch with us today to discuss your requirements.
- Published November 27, 2024
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Emma Beresford
Director at EcoCooling.
Driving the development of sustainable cooling solutions.
An experienced sales and marketing manager, working with SMEs to successfully develop and execute growth strategies. Key achievements have been in the identification and entry strategy for new markets via alignment and reapplication of existing IP/technology to new products and services.
