Ambient Temperature Control: Medicinal Product Storage

Temperature Control: Why is it important?

Storing and transporting medicinal products at the right temperature is essential for ensuring their quality, safety and efficacy.

Medicinal products are sensitive to temperature changes and may lose their potency or stability if exposed to extreme or inappropriate conditions. Therefore, it is important to follow the guidelines and regulations on good distribution practice (GDP) for medicines, which include the requirements for environmental control.

What are the temperature ranges for ambient products?

Ambient products are those that do not require refrigeration or freezing, but still need to be stored and transported within a certain range. The label or outer packaging of the product should indicate the specific storage conditions, such as “store below 25°C” or “store between 15°C and 25°C”. If there are no specific requirements, the product can be stored at any temperature between 8°C and 30°C, which is the general definition of "ambient".

However, some products may have different ranges depending on the manufacturer or the market authorisation holder. For example, some test strips, oncology products and hospital lines may have a narrower range of 15°C to 25°C. Therefore, it is necessary to check the label or packaging of each product before storing or transporting it.

How to optimise temperature control in storage areas

Storage areas for ambient products should be temperature mapped, qualified and validated to ensure that they provide suitable conditions for the products. Mapping is a process of measuring and recording the temperature variations in a storage area over any given period of time. This helps to identify any hot or cold spots, as well as the average and maximum temperatures in the area.

Based on the results of the mapping, storage areas can be optimised by installing air conditioning, moving products away from heat sources or direct sunlight, keeping windows and doors closed, using ambient storage cabinets or reorganising the storage layout. Temperature monitoring devices, such as thermometers or data loggers, should be used to regularly check and record the temperature in the storage area.

Using two monitors at optimum levels of the storage area is the minimum, but at least three is preferred. This way, you can see accurately what the temperature is doing at floor level, mid-height and top level of storage within the building.

Equipment Maintenance

The equipment you use to maintain the temperature and environment in the storage area constantly within the required range, requires the management to ensure that regular servicing, maintenance checks and filtration (if fitted) is replaced. This would be an outsourced activity where specialist engineers will take care of this.
A written report must be supplied to the RP as evidence that such maintenance has been undertaken. This forms part of your QMS and fulfils GDP for documentation.

How to ensure temperature control during transportation

The transporting vehicle of ambient products should be considered as an extension of the storage area, and therefore follow the same principles of temperature control. Products should be transported under label conditions or within the boundaries of the market authorisation. This means that products should not be exposed to temperatures outside their specified range during transit.

To achieve this, various methods are employed such as using temperature-controlled vehicles or couriers, validated shippers or containers, passive or active cooling systems, thermal blankets or insulation materials. The choice of method depends on the type and quantity of products, the distance and duration of transportation, the external weather conditions and the cost-effectiveness.

If the vehicle to be used for transporting the goods is not apparently environmentally controlled, a Risk Assessment must be carried out.

This is to validate the route, any obstacles on the route such as roadworks, the weather (as this can change dramatically over a long distance), careful consideration of the vehicle’s payload area etc. It will be necessary to ensure the receiving customer understands the situation (if they are demanding the goods come what may) and secure their agreement, as part of the Risk Assessment. Whatever happens, the condition of the medicines and patient safety are your top priority.

What are the consequences of failure to control temperature?

Failure to control temperature during storage or transportation can have serious consequences for both the quality of the products and the safety of the patients. Products that are exposed to temperatures outside their specified range may degrade, deteriorate or become contaminated. This can affect their potency, stability, appearance or performance. As a result, they may not work as intended, or a component within the medicine may become damaged i.e; the slow-release component within a tablet may be compromised thus the API is released in the patient to quickly or too early, causing adverse reactions in patients.

The cost of failure

Failure to control temperature would lead to regulatory actions such as inspections, audits, warnings, suspensions or recalls. These can damage the reputation and credibility of the wholesalers, distributors or suppliers involved in the supply chain. Moreover, they can incur financial losses due to wasted products, legal liabilities or compensation claims.

Therefore, it is vital to follow the GDP guidelines and regulations on temperature and environment control for ambient medicinal products. This will ensure that the products are stored and transported under appropriate conditions and reach their intended destination in a safe and effective manner.

Conclusion

A failure in temperature and environmental control in a facility storing medicinal products can be prohibitively expensive and damaging to the wholesaler. Regular maintenance and temperature recording is an absolute priority, to ensure the storage area is maintained within a required range at all times, regardless of the weather outside.

Assistance and Support

EU GDP Guidelines 2013/C 343/01
Chapter 3, section 2, paragraph 1

Why Good Distribution Practice Matters

Online GDP Webinar for RPs and Management

Contracts for Outsourced Activities

MHRA Blog: Temperature Mapping Introduction

Cold Chain Storage of Medicinal Products

Transportation of Medicines in GDP