Spoilage from improper temperature control is the leading cause of damage loss of pharmaceutical products in the cold chain delivery system. Spoilage incurs major losses for the pharmaceutical companies amounting to billions of dollars every year. Improved monitoring techniques are needed to ensure that cold chain tracking measures are in place in order to minimize the wastage.
A cold chain delivery system is a complicated and intricate series of protocols for transferring medical products from the manufacturer to the ultimate user, the patient. Conditions such as temperature, humidity, and weather predictions are all tracked to maintain prescribed settings within shipments. Any deviation, however minor, can destabilize the safety of the goods.
Pharmaceutical Commerce’s 2019 Cold Chain Special Report says that the industry is shifting to “cold chain as a service” by the sellers of packaging and monitoring instruments, and the increasing availability of data — its collection, distribution, and analysis — is critical in managing shipments and achieving the transportation goals.
Cold chain as a service is being applied to the packaging industry to reduce waste in packaging and related materials.
Packaging manufacturers have now stepped up to provide economically viable reverse-logistics solutions, whereby emptied cases can be returned to a local depot for reconditioning, and then sent back into the supply chain.
Cold Chain Tracking Devices
Modern tracking technology is required for temperature-sensitive products in shipping, transporting, and delivering. Tracking makes it easier to monitor the safety of goods and to act on any problems before they progress.
Data loggers allow users to check temperatures at arranged intervals while providing a complete timeline account of the trip. Tracking systems can provide managers with information for taking responsive actions indicated by pattern recognition. By using data collected by these devices over a time frame, operators can identify unusual patterns and where they happen, allowing remedies to be applied regarding suppliers, packaging, and package handling.
Accurate, tamper-proof temperature-monitoring devices are critical to improve cold chain tracking practices and eliminate unnecessary waste. If a temperature excursion does occur, sensors signal those shipments that need further inspection. Cold chains are difficult to track, but using cargo tracking devices can help. In the end, these devices are a cost-effective way to avoid accidents and guarantee product safety.
Pharmaceutical cold chain technologies have improved in leaps and bounds in the last few years, developing better methods to ship and store pharmaceuticals and biologics. The industry for cold chain drug delivery is expected to rise by 59% from 2017 to 2023. This indicates that there will be a growing demand for technologies that meet regulations and provide safe delivery. Approximately 20% of pharmaceutical products are damaged during transport due to temperature deviations. This is an estimated loss of $35 billion per year.
There is a serious need for quality logistics solutions in the pharmaceutical industry. Those solutions will lead to large savings. Around 50% of pharmaceutical products need temperature control. As the manufacturing of vaccines and biologics increases, there will be an increasing demand for refrigerated shipping solutions.
Five solutions in the pharmaceutical cold chain that minimize cold chain costs.
Deep Freeze Reefer Containers – technology in refrigerated shipping containers, otherwise known as reefers, has improved for better temperature-controlled environments over extended periods of time. The reefers have enhanced insulation and back-up systems.
Back-up systems ensure that the temperature remains constant in cases where the primary system fails. Alarm systems signal if the temperature deviates outside set parameters. Management will be notified so they can take preventive actions to protect sensitive cargo. With the new reefers, accessible, long-distance transport of pharmaceuticals is becoming more dependable and cost effective.
Ocean Going Freight Shipping – usually pharmaceuticals are transported via air freight when speed and control of shipments are the best options for temperature-sensitive goods. Airfreight, however, can prove to be expensive, especially in case of unscheduled flight delays. Improper packaging can increase the probability of damage to shipments.
Cold chain monitoring systems produce advantages in cost savings, reduced pollution, and smaller staffing. Improved packing and storage needs, coupled with monitoring systems are very attractive logistics options for pharma companies.
Improved Temperature Monitoring Technology – innovations in technology make it easier to monitor the temperature and integrity of pharmaceutical shipments through the cold chain process. One technique is to attach a small device called a temperature data logger with the shipment.
These devices measure temperature, shock, humidity, and vibration throughout the delivery process. The devices deliver the data to be uploaded into the analytical system. Modern reefers are equipped with electronic trackers for satellite documentation of temperatures throughout the entire cold chain delivery.
If something goes awry, alerts will be transmitted, allowing for backup system to come online to prevent medicine degradation. On-going tracking throughout transport ensures that shipments in the cold chain supply have reached their destination in pristine condition.
Upgrades in GPS Tracking – continuous tracking of temperature-sensitive vaccines, biologics and medications help ensure that the shipment reaches its destination quickly and safely. Air freight shipments are small but often include frequent stopovers prior to reaching their destination. This can compromise the shipment. When transporting pharmaceuticals by sea-going transport, reefer containers have a larger capacity for medical products that can be more efficient, but they run a greater risk of spoiling.
GPS trackers are installed in the shipment or in the container itself. With the use of satellites, companies follow the movement of their shipment in real-time throughout the entire cold chain delivery process. It gives them peace of mind knowing where the shipment is at all times. It also allows companies to respond to any damaging changes in climate or in the delivery schedule. If there is an unexpected delay, companies can notify their providers of the delay and find a better route to speed up the delivery, coordinating with them to take corrective steps.
Warehousing Methods for Pharmaceuticals – identifying a quality monitoring system for warehouse storage can be daunting. Not all drugs have the same temperature, lighting, and humidity setting requirements. Warehouse management must meet the specifications identified by the manufacturer and meet the standards outlined by government regulations.
Improving warehouse management systems (WMS) is one method companies have increasingly available to optimize accurate inventory, timely delivery, and product safety. Better machinery and monitors are used to check storage spaces and deliver pertinent data to the WMS. Automated labor is used to maximize storage capacity, filling in the gaps that would otherwise be challenging to fulfill due to working conditions, while reducing costs.
Is Supply Cold Chain the Lifeline for the Pharmaceutical Companies?
The cold chain for the pharmaceutical industry is not only about delivering supplies, but also providing a lifeline. Product safety is important to the well-being of society. Medical products improve the health of patients. Time is critical when delivering the products. Therefore, the effectivity and potency of the drugs must be safeguarded during the entire cold chain delivery chain.
Intelligent Cold Cargo
A continuous cold chain system can track and protect the quality of goods from the producer to the end-user.
Medical products are vulnerable to transport breakdowns, traffic delays, theft, human error, and other situations. With modern cold chain monitoring systems, the preventive response can be done in real-time, with an entire system reacting as one. A cold chain system can become “smarter” thanks to wireless sensors and oversight capabilities.
Using cloud based technologies
The best way to get real-time monitoring is to use monitoring and communication devices integrated into containers (especially in air cargo ULDs). Dataloggers and communicators with dedicated gateways at key transit areas (airports or seaports), such as satellite-based communication networks (especially for sea freight) can have the transit record transferred into a database. Added to that, are the GPS signals that can make location easier along with humidity, vibration, and light conditions documentation.
Transition to eco-friendly methods
With climate change a real threat to the world, cold chain providers are doing their part to eliminate non-biodegradable containers. They are using reusable containers for case-size shipments of products.
Expanded polystyrene (EPS) or polyurethane (PUR) are still the basic insulation materials for cases. Higher-performing insulation, such as vacuum panels, are preferred by the cold chain providers, offering an extended temperature range for 2°C to 8°C (42.8°F to 46.4°F) shipments, and improved space savings, as the insulation is thinner.
Higher performance insulation is more expensive, however, with standard-size cases priced at over $100 each, whereas the basic EPS ones are under $50.
The usual problem of being green is that it is more expensive. However, the opposite is true when it comes to ocean freight, as it can cut transportation costs by 80% or more. Ocean freight is inherently greener (lower carbon footprint) than air cargo.
On the other side of the cold chain, providers of passive (non-powered) pallet-size containers have also improved their services, including the use of preformed shells (rather than a cardboard box with strapping). In the active-vs-passive pallet shipping question, active containers are still preferred for product protection, but at a higher cost. At the same time, the greater availability of containers is an advantage for passive pallet containers.
An example of a passive pallet shipping advantage is when a provider, on short notice, requires more containers. Providers of passive pallet containers have containers ready to go and can also assemble new ones in a short time.
Another debate among cold chain providers is the use of thermal blanketing for controlled room-temperature (i.e., non-refrigerated) shipments. Thermal blanketing consists of a reflective sheet positioned around pallets while they are on standby in airport tarmacs, to prevent heating by sunlight. They have been upgraded with a variety of multilayer materials (with air-bubble layers, fibre insulation, or other combinations) that can provide enhanced insulation protection.
Traditional insulating-only thermal blankets can mitigate temporary temperature extremes while awaiting transport. More shippers are experiencing increased costs associated with compromised goods and they are looking for solutions. While failure to maintain constant temperature may not result in product degradation, it does add extensive cost and delays to the market due to investigating the loss and product release processes.
New PCM-embedded thermal covers are being implemented for refrigerated and frozen shipments. One mode in the cold chain system that is adapting the new technology is ocean freight. Blanketing is essential during the containers’ off mode between the port’s reefer pad and being plugged into power on the shipping vessel (and also at the destination port). CCT’s PCM covers can retain the temperature inside a reefer for as long as 36 hours while shut down.
The Cellular Genetic Therapies option
Service providers are now helping biopharma companies use new cellular and genetic therapies (CGTs). They are increasing their service offerings, warehousing, logistics capacity, and consulting aptitudes. The cold chain for CGTs is very complicated, while many of the therapy developers are basically scientists and not supply chain managers.
So far, there are only a limited amount of CGTs that have been FDA approved—and a limited number of patients are benefiting from the therapies (often for rare diseases). A few are being cured at a small number of health centers, as opposed to receiving medications at the drug store or getting injections at a local hospital.
Surely, there’s still more to be done to refine the pharma cold chain for everyday commercial shipments. Meanwhile, more attention is being directed to the technological advances in cold chain supply. Technologies such as IoT, satellite and cloud gathering data in real-time, artificial intelligence analysis, and cellular alert notification are gaining ground in services and business practices for the cold chain providers.