Key tips on managing medicines at controlled room temperature
With controlled room temperature (CRT) being one of the newer categories pharma handles in its supply chains, inefficiencies remain in how the industry manages the distribution of these products
The EU regulation overhaul of 2013 handed pharma firms with the new expectation to verify the temperature of medicines which do not require refrigeration during transit.
Medical authorities require that manufacturers guarantee the product stability and shelf life of these medicines by proving the drugs remained at room temperature during distribution and storage.
This extra condition placed added strains on the bottom line of pharma firms as they poured resources into controlling the temperature of these medicines and tracking their climates during transport.
Even today, inefficiencies remain in how these medicines are managed as stakeholders search for techniques to optimise how they control the distribution of these medicines.
Tips for handling medicines within the CRT temperature bracket
As highlighted by the European GDP Association there a several definitions for what qualifies as controlled room temperature and ambient temperature for storing medicines.
Japanese Pharmacopeia (JP)
Temperature in work area
Controlled Room Temperature (CRT)
20°C-25°C with allowable excursions down to 15°C and up to 30°C
Labelling on the medicine should clearly outline the required storage conditions that are determined by stability studies.
Especially when transporting to different regions be sure to detail the specific temperature range required on storage labels rather than using jargon words such as CRT or ambient. The conflicting perspectives on what temperatures those terms refer to in different regions could lead to an excursion.
Avoid using generic profiles:
A generic temperature profile is little unrealistic when validating ambient packaging. Such a profile is unlikely to withstand the large variations in temperature and climate that a lane can travel through in one season.
Unrealistic profiles usually drive overdesign in packaging. This translates into larger, heavier containers which require more insulating material or refrigerant to maintain the necessary temperatures.
Define your ambient profiles so you can fully grasp how they impact the performance of the lane at hand. Some believe that outsourcing ambient temperature profile creation to a 3rd party specialist is the most cost effective route.
Invest to save:
Many governments are pushing for the cost of medications to be lowered, especially generics. This pressure drives shippers to run the most efficient and cost effective supply chains. The upfront validation and assessment of shipping lanes and solutions does indeed absorb resources, however in the long term this will allow pharma to run leaner supply chains.
It’s never too early to re-train staff:
Staff training is essential to ensure the temperature control practices are upheld throughout.
It is vital to informing handlers of when control is necessary.
Use your data to create standard operating practices and evaluate lanes and carriers.
A study found that when looking at pharmacies in India – Sindh, all pharmacies had a temperature that exceeded storage label requirements for medicines (<25degrees) .
In 39 pharmacies the medicines experienced sunlight exposure and only 11% of the dispensers had back up power in the case of electricity shutdowns – which were frequent in this area.
Over a quarter of the pharmacy owners knew of the temperature requirements, but were not abiding to them. This prompted the authors of this paper to call for legislation to legally enforce continuous training programs for owners of such institutions.
Accountability doesn’t have to be expensive
Kevin Kohleriter president of The MarketBurst Group notes that adding accountability to your chain and simultaneously collecting compliance evidence doesn't have to be extortionate.
“Knowing when or where an excursion occurs allows you to assign accountability to the carrier, a location or an individual. Spending a couple dollars on each box to place an indicator and a bit more for a data logger on each shipment can provide evidence of temperature compliance.
“The number and cost of these measurement tools can be based on either the cost of the product, or the likelihood of exposure (crossing climate zones, length of transport, or breaking down shipments). The lowest cost temperature indicator, a ShockWatch Temperature Indicator for example, may be as low as $1 and will take a snapshot of a temperature excursion and show the length of that exposure.
“Temperature data loggers from other companies, like Berlinger, Logtag, or ATI can cost as little as $50 and store up to 8,000 data points. Higher end, networked sensors, like those from Infitrak, Sensitech, or others can even provide real-time alerts, geo-location data, and sense other environmental changes.”
These should be temperature mapped while the warehouse is empty and at full capacity in both the summer and winter to determine maintenance levels in extreme cases. This mapping should be refreshed if there are any changes made to the layout of the warehouse.
Considerations should be made for when climate control systems would be deactivated and the impact of sun facing windows.
Mercy Mvundura's recent study investigated a method used in the final stages in the immunization supply chain.
This strategy allowed particular vaccines to experience ambient excursions up to 40degrees immediately before administration. The author discovered that the approach can reduce supply chain costs for isolated facilities that lack cold chain infrastructure. Read more about this method here.