Cold Chain Storage of Medicinal Products

Cold Chain Storage of Medicinal Products in Wholesale

Cold chain storage is the process of maintaining the quality and integrity of medicinal products that require lower than ambient temperatures throughout the supply chain.

This includes the storage and transportation of these products from the manufacturer to the wholesaler, and from the wholesaler to the end user. Cold chain products are often referred to as ‘fridge lines’ and they include vaccines, biologicals, insulins, and some eye drops. These products are sensitive to temperature fluctuations and may lose their efficacy or become unsafe if exposed to inappropriate conditions. Therefore, it is essential that wholesalers comply with the good distribution practice (GDP) guidelines issued by the European Commission and the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure patient safety and product quality.

How to pack a cold chain product for transport

Before being transported, cold chain products should be packed in such a way as to ensure that the required temperatures are maintained throughout the journey and the products are transported in accordance with their labelling requirements.

 The following steps should be followed when packing cold chain products for transport:

 

• • Use validated insulated containers that can provide adequate thermal protection for the products.
  • Use appropriate cooling elements, such as gel or ice packs, that have been pre-conditioned to the required temperature range.
  • Arrange the cooling elements and the products in a way that ensures uniform temperature distribution and avoids direct contact between them.
  • Fill any empty spaces in the container with suitable filler material, such as bubble wrap or polystyrene chips, to prevent heat transfer and product movement.
  • Seal the container securely and label it clearly with the product name, batch number, expiry date, storage conditions, and any special handling instructions.
  • Monitor the temperature inside the container using a calibrated electronic device, such as a data logger or a min/max thermometer, that can record the temperature history and any deviations.
  • Keep a record of the packing process, including the date, time, personnel involved, container type, cooling elements used, temperature monitoring device used, and any other relevant information.

What NOT to do with a cold chain product

There are some common mistakes that wholesalers should avoid when handling cold chain products. 

These include:

• • Storing cold chain products outside a pharmaceutical refrigerator or in a domestic refrigerator that is not suitable for medicinal products.
  • Exposing cold chain products to direct sunlight, heat sources, or extreme temperatures.
  • Mixing cold chain products with other products that have different storage requirements or may contaminate them.
  • Overstocking or overcrowding the refrigerator or the container with cold chain products.
  • Leaving cold chain products out of the refrigerator or the container for longer than necessary during receipt, dispatch, or delivery.
  • Using damaged or expired cold chain products or cooling elements.
  • Ignoring temperature deviations or alarms and failing to take corrective actions.

What happens if the fridge breaks down?

In the event of a refrigerator breakdown or malfunction, wholesalers should take immediate actions to prevent or minimise the impact on the quality of cold chain products. 

These actions include:

• • Transferring the cold chain products to another suitable refrigerator or container as soon as possible.
  • Quarantining the affected cold chain products until their quality can be assessed by a qualified person or by contacting the manufacturer or supplier.
  • Investigating the cause and extent of the problem and recording all relevant details, such as the date, time, duration, temperature readings, product names, batch numbers, expiry dates, and any other observations.
  • Implementing corrective and preventive measures to restore normal operation and prevent recurrence of the problem.
  • Reporting any significant deviations or incidents to MHRA as required by law.

Correct maintenance of fridges

Wholesalers should maintain their refrigerators in good working order and ensure that they meet the specifications for storing cold chain products. 

This involves:

• • Using pharmaceutical refrigerators that have a fan-assisted air circulation system, a calibrated electronic min/max thermometer with an accuracy of ±0.5°C, a lockable door, and an alarm system.
  • Placing the refrigerator in a suitable location that is away from direct sunlight, heat sources, moisture sources, and dust sources.
  • Setting the refrigerator temperature between 2°C and 8°C and checking it regularly to ensure compliance.
  • Cleaning and defrosting the refrigerator periodically according to the manufacturer’s instructions and removing any expired or damaged products.
  • Calibrating and verifying the temperature monitoring device at least once a year by an accredited laboratory or service provider.
  • Performing routine maintenance and servicing of the refrigerator according to the manufacturer’s instructions and keeping a record of all maintenance activities.

Conclusion

Cold chain storage is a vital aspect of GDP for medicinal products that require lower than ambient temperatures. Wholesalers should follow the GDP guidelines and best practices to ensure that cold chain products are stored and transported under suitable conditions at all times. This will ensure that the products retain their quality and efficacy and do not pose any risk to the patients.

Assistance and Support

A selection of useful links are shown below.

EU GDP Guidelines

Guide to Control and Monitoring of Storage and Transportation Temperature Conditions (HPRA)

Refrigerated medicinal products, Transportation, packing, temperature management (MHRA)

Why Good Distribution Practice Matters

Online GDP Webinar for RPs and Management

The Legal Supply Chain: Protecting the Patients

Temperature Control for Ambient Medical Products