Temperature-controlled logistics are imperative for many pharmaceutical products, as spoiled drugs can severely affect health and well-being.
What is temperature-controlled logistics?
Temperature-controlled logistics or Temperature-controlled supply chain specialises in storing, preserving, and transporting cargo sensitive to atmospheric conditions and needs to maintain a specific temperature. Many pharmaceutical items require this, as rotten pharmaceuticals can have severe consequences for one's health and well-being.
Temperatures above or below freezing can impact the chemical stability of medicine and potentially change its physical qualities. It can take the form of emulsion system sedimentation and separation.
Regulators' standards have become more stringent due to the consequences of incorrectly stored medications, and pharmaceutical businesses must be able to demonstrate that their products are moved via temperature-controlled logistics.
Depending on the product, the margin of error varies. However, the industry has seen a greater regulatory emphasis on drugs that can maintain integrity between 2 º C and 8ºC. This temperature range is called "cold-chain" – a temperature range where the medicine is maintained above sub-zero temperatures. The manufacturer, shipper, and wholesaler are all responsible for ensuring these circumstances.
While the shipping services are responsible for preserving the cargo's temperature, the manufacturer's job is to guarantee that all parties know the product's optimal conditions—some things to consider before deciding on a temperature-controlled supply chain.
• The temperature and humidity levels that are acceptable
• The temperature's margin of error
• acceptable Risk levels
• Areas of potential danger and touchpoints
• Specific acts that are not permitted because they may jeopardise the product's integrity
Additional criteria for choosing a cold storage system include, but are not limited to, the following:
• The medicine's temperature range and volume
• Controls for temperature
• Temperature controls as a backup
• The storage unit's layout and airflow
• Temperature logging and data collection from the outside
• Placement of cargo (avoid areas where temperature variation is likely such as near bay doors)
• Have temperatures been tested?
• The volume of the medicinal product
What are the critical touchpoints?
Logistics is complex, dynamic and ever-changing. As a result, several touchpoints and hand-off processes exist between the various actors involved in the product's distribution.
Risk must be understood to ensure the proper handling of medicines.
Different medicines and transportation methods will come with unique touchpoints. However, here's a rundown of the most common touchpoints that jeopardise your medication.
Getting the product ready for delivery to the shipper – Although the principal mode of transportation may have temperature-controlled storage, does the warehouse where the goods are held before transportation have similar facilities?
Transportation to the shipper location – Refrigerated vehicles or passive cooling systems will have to be considered to ensure that the pharmaceuticals are not tampered with. Similarly, when the goods arrive at the shipper's storage facility, will they be equipped with the necessary equipment to assure the safety of your medications
Physical loading – There must be considerations for ramp management, covered storage, and potential delays. Do all touchpoints have a compatible connection and the ability to generate appropriate watts if an electrical connection to power is required?
During transit – Finally, is the merchandise adequately safeguarded once it is in the cargo hold of the aircraft or vessel? Although the temperature-controlled logistics have been addressed, the location of the cold storage unit is as critical. Keep your medicine away from cargo doors and other cargo in general. The adequate circulation around the product is often required to reach a stabilised temperature. To guarantee that all variables are addressed, a notice to the captain should be issued.
Standards and regulations
Keeping up to date might be difficult due to the complexities of international drug delivery. However, companies operating within the cold pharmaceutical chain must be aware of the latest rules and standards in the market. Some countries may even have safety regulation that involves physically opening and inspecting cargo, resulting in temperature deviations. Therefore, it is good practice to make data and temperature loggers accessible from outside the storage container to keep opening containers to a minimum.
FET Logistics Ltd is a Pharma Cold Chain Logistics Company based in Heathrow and is a pharmaceutical specialist providing reliable logistical solutions across Europe. Get in touch with us to learn more.