Specific temperature requirements for heat-labile medicines and foodstuffs

The thumb rule for heat-labile medicines is to keep the temperature as per their labels or patient information leaflet stable. In many cases, this is 2°C–8°C, though some medicines must be stored at 15°C–25°C or in accordance with further manufacturing specifications. Official guidelines require for storage conditions to be maintained within the limits defined by the manufacturer during transport, without referring to ‘standard’ values which apply to all products.

For foodstuffs, on the other hand, temperatures depend on the type of product and the level of microbiological risk: generally speaking, chilled products must be kept at a low and constant temperature, whilst frozen products require an even more rigorous cold chain. Hygiene regulations governing the cold chain stipulate that storage conditions must be monitored throughout the process, from the warehouse through transport to delivery.

Heat-labile medicines

Medicines that are particularly sensitive to heat, such as certain vaccines, insulin, eye drops and other biological products, must be stored in a fridge and protected from sudden temperature changes. Technical documentation and industry guidelines state that the most common temperature range for refrigerated products is 2°C–8°C (unless otherwise specified).

Some medicines, however, must not be refrigerated and carry warnings such as ‘do not store above 25°C’ or ‘do not freeze’. Hence, it is essential to always read the label and follow specific storage conditions for every single product. Incorrect storage can compromise the stability, efficacy and safety of medicines.

Chilled and frozen foods

For food, correct temperatures may vary depending on the category: fresh or perishable products require refrigeration temperatures, whilst frozen foods require much lower temperatures and a continuous cold chain. European food legislation conceives maintaining the cold chain as a crucial food safety requirement.

In practice, the more delicate the product, the stricter and more continuous temperature controls. This applies to meat, fish, dairy products, ready-to-eat products and prepared foods particularly, which are more at risk of spoilage if their temperature is not kept constant.

Control and traceability

For both medicines and foodstuffs, the key issue is traceability: recording the temperature, monitoring deviations and demonstrating the correct handling of goods. For pharmaceutical products, traceability is particularly important for compliance and audits. For food, it guarantees safety and compliance with hygiene procedures.