Enabling The Intelligent Cold Chain
By Peter Norton, senior consultant for Cold Chain Solutions, Intelleflex
In these turbulent times, pharmaceutical manufacturers, 3PLs (third party logistics), and couriers are searching for ways to maximize profits while facing mounting challenges in their cold chain logistics operations necessitated by the rapid growth of the biologics and other temperature- and time-sensitive biopharmaceuticals. It’s estimated that at least 25% of all pharmaceutical products are temperaturesensitive, and that number is expected to grow to 80% by 2016. These products typically require 2° to 8°C refrigeration and temperature control throughout shipment. Beyond the critical importance of these medicines to the patients, many of these products are often the most expensive products that a manufacturer produces, furthering the need for strict diligence at every step in the cold chain from manufacture to healthcare provider. The loss of these products due to supply chain issues immediately and directly impacts the bottom line. One failure in any part of the shipping process — in a truck, on a tarmac, in the air — means lost revenue, lost product, and most importantly, patients that will not receive the drugs and medications they need.
Facilitating an efficient, effective, and documented temperature-control process is an increasingly essential part of the transit process. What’s equally important is monitoring the temperature of the actual product in the package, in transit. Monitoring the ambient or external temperature isn’t sufficient to ensure the safety and efficacy of the product throughout the cold chain where weather conditions, shipping delays, and a variety of other factors can create problems that impact the quality and efficacy of the products.
Because of this, it’s critical to go beyond monitoring your cold chain; you need to actively manage your cold chain, and that requires having access to actionable data — data that provides the ability to know when a problem is likely to occur before it actually occurs. Actionable data implies that the entire journey must be monitored and documented because each step of the cold chain is equally critical for time-andtemperature control. With actionable data, available on-demand throughout the cold chain, you can anticipate when action needs to be taken when the products in the carton are at risk of being compromised or experiencing an excursion. In-transit temperature monitoring — at every step of the cold chain — provides this capability by providing the ability to “see” inside the carton without opening or unpacking it.
A New Approach
Traditionally, many types of data loggers have been used to monitor the cold chain including chemical, USB, and active RFID data loggers. Each of these types of data loggers, however, has limitations in today’s rapidly evolving cold chain. They either provide no detail about what happened (chemical loggers), they can’t be used inside aircraft (active RFID tags), or they can’t be accessed and read in transit without opening and tampering with the container (USB-based loggers). These tools simply weren’t designed to address today’s rapidly evolving cold chain.
Fortunately, new solutions are becoming available. A new breed of RFID technology known as battery-assisted passive (BAP) RFID offers advantages over legacy temperature monitoring and recording devices for the shipment of temperaturesensitive products from the manufacturer to the healthcare provider. With on-tag memory, BAP RFID maintains a complete record of the in-package conditions with the product, which can be read at any point in the shipping process, as well as providing a documented record at the end of the shipping process. Because BAP RFID tags do not transmit or beacon, they are FAA-compliant for use in airplane cargo holds. But, perhaps most importantly, because of the performance of BAP RFID, temperature-monitoring tags can be read through pharmaceutical packaging without opening or tampering with the container, helping to reduce counterfeiting and grey market diversion of products. Together, these capabilities provide the ability to capture actionable data about the condition of the product and identify issues before they occur, as well as document proper shipment throughout the cold chain. They provide you with actionable data to enable an intelligent cold chain.
Only by providing manufacturers, 3PLs, couriers, and providers with actionable data can the pharmaceutical industry maximize quality and profitability in the cold chain. Forensic or historical data can only document their losses.