Posted by Patrick S. Sedlak, Principal on 01.12.18
Sedlak Consultant Gemayel McAlpine contributed to this post.
Managing the transportation of temperature-controlled products (refrigerated and frozen) totaled over $13 billion in 2017 and is expected to continue to grow at a 5%-6% rate. By 2021 pharma cold-chain logistics – the transport of temperature-sensitive products along a supply chain through thermal and refrigerated packaging methods and the logistical planning to protect the integrity of these shipments – is predicted to be a $16.6 billion industry, according to Pharmaceutical Commerce’s annual BioPharma Cold Chain Sourcebook.
Pharmaceutical cold chain is a major part of the supply chain in the healthcare industry and cold chain logistics services helps the pharmaceutical and healthcare industry maintain a continual supply of drugs from suppliers and distributors in varied (often global) locations.
As manufactured drugs have evolved to contain more high-value active ingredients that have a shorter shelf life and strict temperature requirements, the need for temperature control and monitoring through the entire supply chain has increased. Even drugs that are safe at room temperature may need protocols to avoid the spikes that can come with ambient transportation. Logistics providers are beginning to receive more requests for Controlled Room Temperatures (CRT) which include the use of insulated containers, refrigerants, thermal blanketing, and temperature-monitoring electronics.
For pharmaceutical shippers with temperature-controlled products that are handled multiple times from supplier to end user, quality assurance requires an assemblage of temperature controls, monitoring tools, and coordinated actions all along the supply chain. The following are a few of the challenges in executing cold chain in the pharma industry.
The biggest challenge within cold chain is the delivery is to maintain the 2°C - 8°C range throughout the delivery cycle, which is the most common range for the pharmaceutical industry. Multiple variables can impact the length of time a product’s temperature is considered controlled, including package size and thickness and the type and quantity of cooling agents used. Traditional storage methods of using frozen, water-based gel packs inside insulated containers can be very inefficient, as temperatures can fluctuate within the container (potentially resulting in product degradation), and multiple gel packs add to storage, labor and shipping costs.
Finding qualified carriers can add to this challenge, as temperature-controlled transportation requires specialized trucks and equipment, specific driver training, and increased liability in an industry coping with driver shortages and capacity constraints.
Another challenge is temperature monitoring of high-value products. Without a monitoring system in place, pharmaceutical manufacturers lose control over their product as it moves up the supply chain. If a customer decides the cooler is “not cold enough” upon receipt of the product, it can lead to a return claim and potential delays for providers or patients.
For companies that outsource logistics, their providers and carriers become a critical piece in a process with a high level of risk, given the cost of product development and the potential impact on patient outcomes. Sensor technologies and recordable devices such as RFID tags can enable companies to monitor and manage cold chain logistics from suppliers to end users.
The growth of globalization and increasing pharmaceutical mandates by country or region are causing many pharma manufacturers and 3PLs to implement more stringent practices in order to stay ahead of the regulation. In the EU, for example, about 80 percent of pharmaceutical products require temperature-controlled transportation.
Serialization regulations, for example, add complexity and cost, as products that cross national borders must meet the serialization requirements of each individual country. Demand for visibility across the supply chain, including location and temperature monitoring no matter where in the world product is moving, is driving the technology market to develop solutions to track and deliver data in real time.
Critical Questions for Achieving Cold Chain Security
As the pharmaceutical cold chain industry expands its reach, manufacturers, logistic providers, and carriers will need to continue to coordinate actions to address the ongoing challenges of cold chain logistics. Some key questions:
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