The global healthcare cold chain logistics market size is expected to grow from $8 billion (2014) to $11 billion by 2018 with a third of that in the temperature-controlled packaging and service solutions arena. Although the industry is growing, that’s doesn’t mean it’s without challenges.
A big contributor in volume growth will continue to be an increasingly aging world population and the introduction of biotechnology-derived large molecules requiring refrigerated storage handling at 2- to 8-degrees C.
We’re seeing all of this, combined with expanding global market penetration. Emerging markets include Asia, India, China and South America—all with long, complex shipping lanes requiring more stringent temperature control and monitoring measures to ensure product safety.
Managing risk has attracted more aggressive regulatory positions from a number of influencers, including the European Union (EU), U.S. Centers for Disease Control and Prevention, and the World Health Organization (WHO). Failing to meet any of these regulations could not only result in a loss of product efficacy, but the potential of unwanted publicity and ultimately fines.
Shippers and manufacturers, which are ultimately responsible for examining their supply chains, should do so using a risk-based approach. A risk-based approach calls for evaluation of both the currency of the solution and possible sources of harm.
Currency of solution
Comprehensive thermal tests and qualification processes are needed to ensure that temperature controlled packaging solutions meet the complex needs of health care originations, including compliance with global industry standards. When doing this, helpful tools to have in place include:
• ISTA-compliant certified thermal testing labs (ISTA is the International Safe Transit Assn.).
• Calibrated environmental chambers.
• A full range of conditioning equipment.
• Multi-physics technology to produce virtual prototypes.
• Thermal modeling and mapping capabilities.
Thermal-controlled shippers are continuously improving. In-depth analysis, including an evaluation of the time elapsed since the valuation of temperature-sensitive shipping and packaging solutions currently in use, is essential to making sure that shippers are continuing to provide an efficient solution.
Sources of harm
When it comes to the transportation of temperature-sensitive biologics and other pharmaceutical products, the ability to prevent temperature excursions should be the first priority. Although it can be a demanding task, it’s important for stakeholders to identify the potential sources of harm to a payload being transported through a variety of modes, several temperature zones and multiple transit points.
When evaluating possible sources of temperature excursions, it’s important to consider route, logistics provider and the packaging solution in place.
Each of these of these can play a role in the prevention of temperature excursions. However, risk management should not be centered only upon the choice of which route, which logistics provider and which type of packaging solution to use.
Because packaging and solutions providers have experience solving cold chain problems, these organizations can help identify appropriate cost saving pre-existing temperature-controlled packaging solutions with the best fit for purpose thereby side stepping a customized solution.
Here are seven critical factors to evaluate as part of the packaging solution selection process:
1. Performance needs, such as payload volume, temperature range and duration needed.
2. Ease of pre-conditioning/pack out, universal or seasonal.
3. Quality, specifically as it relates to regulatory needs, validation testing requirements and product tolerance level.
4. Pricing considerations, such as packaging cost, payload volumetric efficiency, packaging weight and total freight costs, as well as end-to-end shipping lane analysis.
5. Safety, including temperature data monitoring, shipment track and traceability.
6. Sustainability, considering single use versus reusable, closed-loop reverse logistics services.
7. Total cost of ownership.
For those in the highly regulated and competitive life sciences and pharmaceutical industries, a risk-based approach to evaluating cold chain isn’t just about mitigating risks typically associated with supply chains. It’s essential to maintaining a successful business. In these industries, preventing the risks associated with cold chain mean the difference between success and failure, profit and loss.
Kevin Lawler is the vp of sales at Pelican BioThermal. With more than 25 years of sales leadership experience, Lawler has a strong history in building and leading sales organizations capable of producing strong and predictable growth. Prior to joining Pelican BioThermal in 2009, he was a leader in the growth of Computech Resources into a $35 million technology and consulting services company, positioning it to be acquired by Logicalis Inc., a $1billion global technology organization. Lawler earned an MBA from the University of Montana and resides with his family in St. Paul, MN.
Learn about the latest solutions in pharmaceutical packaging at EastPack 2016, June 14-16, in New York City.