Temperature-Controlled Transport – How to Achieve a Better Cold Chain?
We all know how difficult it is to transport delicate and sensitive drugs and vaccines. No matter how difficult, it is necessary, nonetheless. Patients need these products. To receive them, patients rely on pharma and logistics companies.
Maintaining cold temperatures is challenging. Problems and failures are bound to happen. To prevent these, companies follow several measures and best practices. It is possible to achieve an efficient temperature-specific supply chain.
Challenges in Delivering Temperature-Sensitive Products
Temperature-specific supply chains use varied types of technologies and systems, depending on the products involved. Different products require different specific temperatures to remain stable and effective.
- Ambient or controlled room temperature – 20°C to 25°C (68°F to 77°F)
- Refrigerated or cold chain – 2°C to 8°C ( 35.6°F to 46.4°F)
- Cryogenic or deep freeze – below 0°C to as low as −150°C (32°F to -238°F)
While the majority of products remain effective despite ambient temperatures of up to 40°C, a large percentage of these temp-specific products cannot withstand such environments. Hence, they rely heavily on cooling technologies. Since cooling technologies are prone to failures, the safety of some of these delicate products is at stake.
Apart from that, temperature is not the only factor affecting these sensitive products. They also react to changes in humidity, light, vibration, and shocks.
What makes transport even more difficult is that pharmaceuticals today are increasingly sensitive. That’s because biological-based products are more sensitive than chemical-based products.
Biological products, or biologics, are produced from living organisms or products containing living organisms. Examples include vaccines, blood, blood components, cells, allergens, genes, tissues, and recombinant proteins.
What can harm all these products? Some of their sensitivities include the following:
- Too hot or too cold temperatures
- Packaging failures
- Incorrect handling
- Cold air or hot breezes in the place of transport
- Inconsistent weather
- The intensity of sunlight affecting improperly packed products
The consequences for these products can be that they may be rendered ineffective, or, at worst, they become life-threatening.
For example, vaccines can lose stability when there is a disruption in the cold chain. When mistakenly used despite their impotence, patients will no longer be immunized from the disease which the vaccines intend to prevent. Patients can still contract diseases. If that happens to one person, chances are that some percentage of the population will also be administered ineffective vaccines. Worse, there could be increases in local transmission of the disease, since vaccines were unknowingly ineffective.
Damaged products can also be directly fatal. In August 2017, sub-freezing temperatures damaged a shipment of Intralipid 20% IV fat emulsion. The company reported the incident two months later, and warned the patients to dispose of their supplies. When the product freezes, its emulsion droplets enlarge. It then forms aggregates that can obstruct pulmonary circulation—leading to serious health problems and possibly, death.
Humidity, shocks, and vibrations are also something to look for in visibility data. When solid products are not well-packed, humidity can change their characteristics. When products are friable, shocks and vibrations can easily damage them.
Aiming for Improved Education and Regulation
A holistic approach to logistics is one of the most effective preventive measures for maintaining vaccine safety. Defining standard operating procedures is a first step. A dedicated logistics team can prevent damaging consequences by following well-crafted procedures. Some of these standard procedures include:
- Thorough risk assessment
- Environmental Condition Monitoring
- Temperature Monitoring
- Time Visibility Solutions
The most often overlooked aspect, however, is education. “Too many pharmacy education programs fail to teach the details of temperature-controlled logistics management and its importance for efficacy to the patient,” says Mark Maurice, Professional Services Senior Project Manager in Life Sciences at Sentech, a supply chain visibility company.
To improve logistics education, companies can recruit experts in the industry. They can hire third-party logistics (3PL) firms who have wide experience in the temperature-controlled supply chain.
Logistics providers who have expertise in the cold chain, controlled temperature chain and the like, adhere to regulatory bodies such as the World Health Organization (WHO), UNICEF, International Air Transportation Association (IATA), U.S. Department of Transportation, Transportation Security Administration, U.S. Customs and Border Protection, and per country’s FDA.
How Packaging Affects Efficiency
Time and temperature-sensitive products require the most efficient logistics. That alone, however, doesn’t guarantee success. Their packaging — containers and carriers — is equally important.
“The responsibility lies with the pharmaceutical shippers to ensure appropriate packaging,” says Andrea Gruber, Senior Manager of Special Cargo with IATA.
Environmental conditions must also be considered, however, as they determine the best type of packaging.
According to Pharmaceutical & Medical Packaging News’s 2015 survey of temperature-sensitive supply chain experts: One-third of companies prioritize the packaging process. Only one-fifth know the environmental conditions of their product while in transit.
This lack of knowledge will cause a lack of effective packaging solutions. Packaging solutions rely on ambient conditions. While an expert audit is the best way to know if their packaging solutions are working, only half of the respondents seek those services.
Packaging has two types: active and passive. Active packaging requires a power source: electricity, battery, or solar. Passive packaging, on the other hand, relies on coolant packs, such as water-packs and phase change materials (PCMs).
Active containers, such as refrigerators and reefers, have their set of challenges such as mechanical issues and expensive maintenance. Passive containers are burdened too, with specific problems, such as inconsistent cooling and fluctuating temperatures.
Containers like these are used depending on the type of products. No matter how effective the container is, proper handling will improve results.
Proper handling includes specific freight-forwarding instructions that concern these factors: government and other regulations, temperature sensitivity, shelf-life considerations, and transportation conditions.
A Better Way to Transport Temp-Specific Products
Many risks are present during transit. Failures and errors await, especially since many more pharmaceuticals are traveling in the skies, seas, and over land than ever before. Most of the time, routes are long and complex. The distance results in the need for several exchanges and drop-offs.
Having many of drop-offs entails multiple modes of transportation. The more modes of transportation involved, the more hangar and dock delays. Delays can place waiting shipments in environments that could be hostile for them.
The International Air Transportation Association (IATA) has recognized these problems. That’s why they created the Centre of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma). This is a globally recognized certification program for pharmaceutical air shipments. This ensures that the right processes, people, and infrastructure are in place to handle and transport sensitive shipments. To receive this certification, supply chain companies can voluntarily ask for assessment and validation from the IATA. Do note that not all logistics companies are CEIV certified.
Visibility Solutions in Mitigating Damages
To achieve a better supply chain, monitoring solutions should be a top priority. Monitoring is all the more important for sensitive products like pharmaceuticals.
Here are some of the data that needs to be monitored while in transit:
- Package Location
- Vehicle Location
When it comes to the cold chain, the last thing desired is delivering packages past their expiration dates. Another example would be delivering frozen ice packs that endanger freeze-sensitive products. Events that happen without the management or pharma companies noticing, must be prevented.
In fact, instances like these do happen. When it’s too late to apply system corrections, there’s no way to prevent financial losses. When most of the data mentioned above are monitored in real-time, then these possible risks can be mitigated.
With timely notifications, pharma stakeholders can call for interventions once failures are detected. Here are some of possible interventions when there are real-time data monitoring solutions.
- Reroute shipments
- Reposition shifted packages
- Readjust temperatures
Today’s sophisticated monitoring programs examine the distribution process—over time and in real-time— identifying unexpected events and predictable trends.
Pharma and logistics companies can use the collected data to:
- Inform required changes
- Improve quality control
- Meet regulatory requirements
- Reduce costs
How do some companies monitor their packages?
United Parcel Services (UPS) owns 50 healthcare facilities around the globe. These facilities can provide temperature-controlled options for all of their clients. They also provide warehousing and storage solutions, quality-assurance, and product-protection services. Aside from their solutions, they have a “Temperature True” option for temperature-sensitive air and ocean freight — all with proactive monitoring and intervention services.
FedEx, another major player in logistics, offers “Temp-Assure” portfolio that maintains the products at a consistent required temperature, from deep-frozen to controlled-room. During bad weather, the company moves the products into an in-transit, temperature-controlled storage, preventing spoilage in case of delays. Sense-Aware, the company’s real-time sensor-based monitoring system shows whether a shipment has been opened or subjected to light, humidity, or sudden movement.
For CEIV certification, Delta Cargo equipped their warehouses with temperature-calibrated coolers, using thermal mapping to assure temperature consistency throughout. In physical spaces, temperatures will vary near air vents, open doors, heaters, and fans. That’s why thermal mapping is necessary to acquire certification. It can record fluctuating temperatures, in three dimensions—in the top, bottom, sides, and middle of a storage room, container, or vehicle.
Sentech also provides Thermal Mapping Services and self-administered Thermal Mapping Kits. In McKesson’s facilities, radio frequency identification data (RFID) provides real-time monitoring and tracking. Temperature and humidity sensors that are connected to the company’s computer systems, record problems, should they occur.
Advancements in Vaccines and Biologics for a Better Cold Chain
Companies that keep abreast of developments remain competitive. Whatever is their role in the supply chain, constant research and innovation is the key to remaining vital in the industry. So does the role of life sciences.
Life sciences also contribute research and innovation. For example, Stone Stable, Inc., a Portland, Oregon-based start-up connected with Portland State University (PSU), works to revolutionize vaccine stability. They are experimenting with coating viruses in silica, rendering them inert and impervious to hot and cold temperatures, then later returning them unharmed to their original state. They are in the first phase of testing the process with the influenza vaccine.
“On the molecular level, we’re working at building a kind of ‘nanobridge’ around a drug particle, to prevent it from becoming inactive,” according to virologist Ken Stedman, Ph.D., Founder of Stones table and Professor at PSU. “The pharmaceutical company would integrate these particles, our proprietary technology, into its existing drug-manufacturing process. This would remove refrigeration from the equation and allow the vaccine to survive at room temperature. When it’s injected into the patient, the silica would dissolve in the bloodstream, and the vaccine would take effect.”
In another laboratory, Harvard-based Vexes Technologies is turning to silkworms to help alter the behavior of vaccine molecules. This process saves the drug from degradation in higher than room temperature. When vaccines are exposed to heat, two things happen: heat causes charge-based molecules to stick together; and heat denatures the vaccine antigen, changing the molecular structure.
Vexes broke down the silkworm-made fiber into a protein solution and turned it into different materials with unique properties. These can entrap the vaccine molecules so they won’t change and won’t move around or stick to each other.
On another technological front, these drug developments will also make use of drones for transport. Drones are beneficial for people in disaster and weather-stricken places, rural areas, war zones, and third-world-countries.
Temperature-controlled supply chains are plagued with many challenges. Because most products in this type of supply chain are life-saving and vital products, pharma companies need to continually improve its most problematic, weakest link. While improvements have been made in the past decade, the increasingly sophisticated needs of so many patients across the world continually propel pharma and logistics companies to deliver better services.