Temperature controlled logistics involves the storage, preservation and transportation of cargo that is sensitive to atmospheric conditions and requirements to maintain a certain temperature. This is very important for medicinal products, as spoiled drugs can lose their efficacy and have serious consequences on the patient’s health and wellbeing.
Elevated or sub-zero temperatures can affect the chemical stability of the medicine and may even alter its physical properties. This can occur in the form of sedimentation and separation of emulsion systems.
Due to the implications of improperly stored drugs, regulator demands have become more stringent and pharmaceutical companies need to be able to prove that their products are transported via a temperature-controlled supply chain.
The margin of error is different from product to product, but the industry has seen greater regulatory emphasis on drugs that can maintain integrity between 2ºC and 8ºC. this temperature range is referred to as “cold-chain” – a temperature range where the medicine is maintained above sub-zero temperatures. These conditions must be assured by all parties, including the manufacturer, the shipper, and the wholesaler.
While shipping services are responsible for maintaining the temperature of the cargo, it is the manufacturer’s responsibility to ensure the optimal conditions for the product are understood by all involved parties. There are several considerations to think about before choosing a temperature-controlled solution:
- The acceptable temperature and humidity range
- The margin of error for temperature ranges
- Acceptable and potential levels of risk
- Specific no-go actions that may compromise the integrity of the product
Additional conditions for selecting a cold storage system should be bases, but not limited to the following criteria:
- The temperature range and volume of the medicine
- Temperature controls
- Back-up temperature controls
- The layout of the storage unit and airflow
- External temperature logging and data tracking
- Cargo placement
- Whether temperatures have been tested
- The volume of medicinal product
Some argue that the biggest consideration when choosing transport for pharmaceutical logistics is the risk to the end-user if there is a delay or problem with the shipment. Either way, thorough risk assessments are necessary when selecting a suitable mode of transport and considerations must be made about the costs of replacing the product if something goes wrong.
Logistics is complex, dynamic, and ever-changing. As such, there is a wide array of touchpoints and hand-off processes between the various actors involved with the distribution of the product. It is important that these areas of risk are understood to ensure the proper handling of medicines.
Different medicines and different transportation methods have their own unique touchpoints, but here is a rundown of the most common risks to your medicine:
- Preparing the product for transport to the shipper location. The primary transportation method may have temperature-controlled storage facilities, but the warehouse the product is stored in prior to transportation may not.
- Transportation to the shipper location. Refrigerated vehicles or passive cooling systems will have to be considered to ensure the drugs will not be compromised en-route. Similarly, once the product reaches the shipper’s storage facilities, it should have the required apparatus to ensure the safety of your medicines.
Minimizing the amount of time, the drugs spend at ambient temperatures is critical, especially in warmer climates. Walk-in cold storage rooms or dry ice can be used to help maintain the temperature of active and passive containers.
- Physical loading- Ramp handling, covered storage, and potential delays need to be accounted for. Additionally, if an electrical connection is required, do all the touch points have a compatible connection and ability to output appropriate wattage?
- During transit- Finally, once the product is in the cargo hold of the aircraft or vessel, is it being sufficiently protected? The temperature controls may have been taken care of, but the positioning of the cold storage unit is just as important. Avoid storing the medicine near cargo doors and other cargo in general. Adequate circulation around the product is often required to reach a stabilized temperature. A notice to the captain should be issued to ensure that all variables are taken care of.
Furthermore, it is important to ensure cooling apparatus remains active for the duration of the transit. Mistakes can be made with energy saving modes being turned on without notice, and cooling apparatus being switched off during rest periods.
Standards and regulations for temperature-controlled logistics
Companies operating within the pharmaceutical cold chain must be aware of the latest rules and standards in the market. Due to the complexity of transporting drugs internationally, keeping up to date can be a daunting task.
Some countries may even have safety regulations that involves physically opening and inspecting cargo, which can result in temperature deviations, it is good practice to make data and temperature loggers accessible from outside of the storage container to keep opening containers to a minimum.
In the EU, the directive 2001/83/EC is the foremost legal document with regards to governing the production, distribution, and use of medicinal products.
In addition, regulations are routinely published in the following groups:
- European Union
- World Health Organization
- Parenteral Drug Association
- International Air Transport Association
Types of temperature-controlled logistics
- Refrigerated vehicles. This category includes conventional vehicles that have thermostatically controlled cargo compartments, enabling the temperature range to be maintained. Refrigerated vehicles often come in the form of small vans and trucks, which can be equipped with electronic control systems to manage temperature. While some vehicles in this category rely on the engine to supply power to the refrigeration unit, larger vehicles have independently powered units and electrical backups.
- Passive shipping container. Passive shipping systems are storage containers that utilize a combination of insulating materials and electronics to maintain a temperature range. While they do not require human or external input to function, they can only maintain a temperature range for a set period before they expire, making them an effective option for short journeys. Impact resistant containers are often needed to mitigate any potential damage to the transported cargo during road transportation. Passive shipping systems can be used alongside the other major types of temperature-controlled logistics for an additional layer of protection.
- Active shipping system. These are like passive shipping containers but are much larger in scope. Active shipping systems are used abroad airfreight and sea freight shipping- and are effectively large thermostatically controlled cargo containers. On air freight, they are typically powered via internal batteries or an external electrical source and maintain power via large cooling fans and heating mechanisms. Meanwhile, sea freight active shipping systems are generally powered by the ships onboard power supply.
Air freight temperature-controlled logistics
Air freight is the most popular form of temperature-controlled transport, as this method can help alleviate time considerations, geographical obstacles, and a lack of infrastructure. Air transportation is even the most popular mode of transport for in-country logistics.
- Capacity oversupply- Overcapacity has created more competitive service for manufacturers and as a result, services have become more temperature-controlled and pharmaceutical focused, which I positive for the quality of the products.
- Weak points- It is very acknowledged that the weakest points in the air freight supply chain are the transfer points between the different players. Staff training, increased planning for the aircraft type and increased due diligence are areas that require more attention.
- Cost efficiency- A key element of cost-saving and efficiency in the air freight industry is modernization and the use of technology for process improvement and optimization. Like other industries, pharma logistics companies face the challenge of incorporating digitization, despite the cargo industry not being technology-driver.
- The future of air freight- With the demise of huge blockbuster drugs hitting the market every couple of years, the generics industry now covers a large proportion of the genetic medicines that are being delivered to patients. Transportation methods will be approached in a far more cost-conscious manner in the years to come.
Types of air freight
- Commercial airlines- Commercial airlines tend to primarily transport passengers, but most offer cargo services to take advantage of airport destinations. However, commercial airlines tend to have smaller storage capacity in comparison to dedicated cargo airlines. In addition, cold storage apparatus will likely be retrofitted within the airliner and hired from a third-party company, as opposed to being an innate feature of the airliner. Coordination will be balanced between a freight forwarding agent and the airliner.
- Integrators- Integrators refer to dedicated mail delivery services such as DHL and UPS. These companies will coordinate directly within airlines to ensure the optimal delivery of the drugs.
- Specialized cargo airlines- Cargo-only aircraft do not carry passengers and have substantially more room for cargo as a result.
Sea freight temperature-controlled logistics
In the last few years, the price of air freight has been on the incline; as a result, pharmaceutical companies all over the world are looking for alternative cost-effective methods to transport their life sciences products. Sea freight is the major alternative and is becoming increasingly more viable in comparison to air freight.
Around 20 per cent of pharmaceutical payloads are moved via ocean freight however its forecast this will increase to approximately 75 percent within the next decade. Here are the pros and cons of sea freight:
- Cost effective. Sea freight temperature-controlled logistics is substantially cheaper compared to air freight shipping.
- Less risky. Sea freight offers a more controlled environment in comparison to air freight. There are fewer control points and disruptions, as sea freight cargo will not be touched until it reaches its destination.
- Easier to monitor. Sea freights are continuously improving, and most services offer real-time tracking and monitoring – further reducing the risk factor.
- Fewer temperature excursions. This provides an unbroken cold chain and less exposure to ambient temperatures.
- Seasonal products. Transporting seasonal products to the market such as the flu vaccine. Sea freight will always be slower than airfreight.
- Agility. The pharmaceutical industry cannot react to very short lead times.
- Inaccessible locations – Delivering temperature-controlled products to remote in-land locations via sea freight can be time-consuming.
Airfreight or sea freight?
Adam Tetz Peli, Bio Thermal’s director of worldwide marketing, says: “There will always be a need for air transportation when emergencies arise and there is the need to get products shipped more quickly.
"As regulators introduce tighter rules around transport and logistics, and more temperature-sensitive medicines enter the market, the gap between air and sea transportation will narrow. However, it will not make other forms of transportation redundant."
Some pharma products will always be in high demand or have a high enough value to only travel by air. There will always be emergencies and natural disasters that require pharmaceuticals to be transported quickly. Shipments sent over water could be unavailable for four to six weeks, so air transport is a valuable logistics service when speed is called for.