In the pharmaceuticals industry, temperature-controlled logistics is crucial. This is because many pharmaceutical products can have significant implications if they are spoilt due to incorrect storage practices or temperatures which are too high. Some medications can become ineffective if they are stored at the wrong temperature which can prove dangerous for patients. Temperature controlled logistics in the pharmaceuticals industry specialises in the preservation, storage and transportation of products which are sensitive to atmospheric conditions and to maintain a consistent temperature from collection to delivery. Raised temperatures or those that are too cold can affect the chemical composition of the medicine and can even affect its ability to function. This industry is strictly regulated which means that pharmaceutical companies need to provide evidence that the products they supply and distribute are transported properly and in the right conditions.
In the pharmaceuticals industry, the margin of error is different between products, but ideally, the temperature must be maintained between 2°c and 8°c. This temperature range is referred to as the cold chain and this temperature must be observed at all stages in the supply chain from the manufacturer to the distributor to the wholesaler.
Distributors of temperature-sensitive products need to take the following into consideration:
- Acceptable ranges for both temperature and humidity.
- Margin of error in temperature fluctuations.
- Acceptable levels of risk throughout the journey.
- Areas of risk and touchpoints.
- Strictly prohibited activities that could affect the safety of the product.
- When choosing the temperature-controlled vehicle for transportation, the following also need to be considered:.
- The medicine that must be transported, the quantity and temperature range.
- What temperature controls are in place.
- Whether there is a back-up system in place in case of main system failure.
- How external temperatures are monitored and the ways in which data is tracked.
- The placement of the products being transported (avoiding areas where the temperature is likely to vary such as near doors).
- Whether facilities are available onboard to test the temperature.
- Critical Touchpoints.
The movement of products in the pharmaceuticals industry is a complex task. Throughout the journey, there are various touchpoints and processes involved in the distribution process. Therefore, it is essential that businesses understand the risks to ensure that medicines are handled properly.
Vehicles used to transport the medication must meet strict standards for cooling. The use of advanced technology such as Transcan can accurately monitor the temperature and keep it stored for up to 2 years.
Different medications will require different transportation methods and each one will require their own unique journey planning out. Some of the most common touchpoints that present a risk include:
Preparing the product for transportation – While the product may be transported in a temperature-controlled vehicle, it’s important that the warehouse also has properly regulated temperatures before the medicines are loaded into the vehicle. The refrigerated vehicle will need to be carefully monitored throughout the journey to make sure that the temperature is consistent.
Loading – Handling, storage and delays in the process must be factored into the decision-making process, so too should be electrical failure.
During Transit – Once the product is being transported in the vehicle, will it be properly protected and kept at the right temperature for the entire duration of the journey? Adequate air circulation is important so too is the placement of the products.
Any business that operates in the supply chain for temperature-sensitive pharmaceutical products must be aware of the rules and regulations. It is, therefore, good practice to have a temperature logging system in place which can automatically take and record the temperature at intervals throughout the journey.
The European Good Distribution Practice Guidelines
In 2013, the European Good Distribution Practice Guidelines were established, and they relate to quality assurance for medicines within the European Economic Area (EEA). This guidance outlines the standards that businesses in this industry must comply with and how they must make sure that these standards are reflected in every stage of the distribution process. Industry guidance states that medicines must be distributed without any alteration to their properties. When there is a fluctuation of temperature or medicines are stored incorrectly, this can affect the properties of the medication and its ability to work properly. The best way to ensure the integrity of the medication is to observe and maintain adequate storage conditions from the moment it is collected to the second it is delivered to the required location.
Businesses should put in place suitable procedures to monitor both humidity and temperature and vehicles should include alarms and notifications that alert the driver to an issue or a fluctuation in temperature. These alerts will ensure that problems are quickly identified and addressed.
In the cold supply chain for the pharmaceuticals industry, comprehensive procedures are required to ensure that medications can be fully traced through the entire distribution process. This would require detailed documentation that can be created across multiple distribution channels to locate the journey of a particular product. When products can be traced, it is easier for them to be monitored and the process runs more efficiently.
The method of transportation should be chosen with care. Local conditions should be considered such as climate and seasonal variations so temperatures can be adjusted accordingly. Delivery schedules are essential, so too are route planning strategies to get the temperature-sensitive goods to the required destination in the shortest possible time frame.
The cold supply chain for pharmaceuticals is a challenging process but with the right systems in place, it is easy to transport medicines safely and effectively.
If you would like to find out more about temperature-controlled logistics and the different types of vehicles that are available for your business, please contact our team or browse our service pages to see the logistical solutions that we offer.