Many medicines can be destroyed by storage and transportation at the wrong

Almost one third of “critical and major deficiencies” uncovered in the storage and transportation of medicines relate to the control and monitoring of temperature, according to the Medicines and Healthcare Products Regulatory Agency (MHRA). The Agency reported in 2009 that problems with temperature accounted for 30% of deficiencies, which is more than quality management failures (25%), documentation (24%), problems with premises or supply (8% each), and products (5%). MHRA bases its guidance about storage and transportation on EU guidelines on Good Distribution Practice (GDP), which demand that distributors “ensure that storage conditions are observed at all times, including during transportation”. This not only applies to medicines that need to be stored at low temperatures (cold chain products), but also to medicines that should be stored below 25°C or 30°C (temperate chain products). There is also a smaller, but growing, subset of products that need to be kept at sub-zero temperatures, and it is not only high temperatures that can present a problem, when products such as vaccines, insulin, biotechnology products, and blood products, can all be denatured by freezing. Following dispatch from a manufacturing facility, the distribution chain for medicines can be complex, potentially involving several storage facilities, wholesalers, and modes of transport. Effective systems to measure and record the temperature at which products are held at every stage of their journey are therefore an important feature of systems designed to protect the quality of medicines ultimately administered to patients. All distributors of medicinal products are required to record storage and transportation temperatures, as well as being licensed by the MHRA or its equivalent national regulatory body. 

Storage requirements 

For instance, storage facilities looking to handle significant volumes of high-risk cold chain products need specialist refrigeration capable of holding contents reliably at between 2°C and 8°C throughout the storage volume. As a minimum in small fridges, temperature monitoring should be performed by electronic maximum/minimum thermometers accurate to ±0.5°C. Continuous, independent, recording with alarms is also advisable. Probes should be placed within the load (or within a suitable buffer) so that they record the temperature of the products, and not the air. Maximum and minimum temperatures should be logged daily. Larger refrigerators and walk-in cold rooms used in high-volume operations should be fitted with an electronic temperature-recording device that measures load temperatures. The chart, printout, or direct reading, should be checked and recorded daily. Paper records do the basic job, but it may be worth considering electronic recorders, which offer several advantages. For a start, videographic recorders can display multiple readings at a glance, making it much easier to keep track of installations that need to deploy a network of multiple temperature probes. The latest recorders also offer communications capabilities. For example, ABB units can be connected to wider control systems via Ethernet. This makes it easier to notify a central controller when a potential temperature problem triggers an alarm, or the system could be set up to send an SMS message to a responsible person so that remedial action can be taken right away. The third advantage is that electronic logging makes it easier to retrieve data days, weeks, or even months later, making batch traceability much easier if a problem comes to light later on.