2015 UPS Healthcare Forum Pushing What s Possible
Reinventing Cold Chain For Controlled Room Temperature Products: Reconciling Compliance with Cost Effectiveness Tim Fosnough, Global Director of Freight Forwarding Healthcare, UPS Susan Li, Marketing Manager, Healthcare Strategy, UPS Overview Transporting controlled room temperature (CRT) products is a challenge for a number of reasons. Global regulatory changes are driving significant changes for CRT logistics. Companies must balance the cost of transportation, packaging and monitoring with factors like product value, patient safety and more. To help companies make decisions about how best to balance these factors, new technologies, approaches to information sharing and bundled solutions are emerging. Companies must determine which options best meet their costbenefit needs. Context Tim Fosnough and Susan Li held two roundtable sessions with pharmaceutical/biopharmaceutical manufacturers, diagnostic labs and CROs to discuss the latest trends and best practices in packaging, monitoring and transporting controlled room temperature products. Key Takeaways Logistics for CRT products is challenging because companies must balance cost, regulatory compliance and temperature requirements. During the roundtable sessions, participants shared their concerns about shipping CRT products. These concerns include: When building a supply chain, one can t assume that everyone has the same definition of CRT requirements. Unlike refrigerated cargo, ambient CRT products have different temperature requirements. Some need to be kept between 15 and 25 degrees Celsius, while others can go as high as 30 degrees and others as low as 2 degrees. Even within a single organization, there may be multiple definitions of CRT. Within a single company, there can be as many as 15 different definitions of CRT which makes it challenging. When you build a CRT supply chain, you can t assume that everyone is thinking the same thing. Tim Fosnough Regulatory pressures are an emerging issue for CRT products. The U.S. Pharmacopeial Convention (USP) is increasing the attention paid to label claims, as well as to maintaining temperature from transit through storage and to the end customer. More consumer education about home storage of products is needed. Even if a product has been transported through the cold chain without any problems, refrigeration at the end consumer s home may not be adequate. As consumers get more educated, however, it is more likely that an adverse effect will be linked to improper shipment of CRT products. Cost issues are top of mind, since many CRT products are low value. Companies must make cost tradeoffs between faster transportation versus more efficient containers that can maintain temperatures during a longer journey. When it comes to packing materials, ice packs are the cheapest, but they are heavy and ice melts at around the ideal temperature for CRT products (22.5 degrees Celsius). Other more efficient packing materials, like gel packs, are more costly. With regard to monitoring, expensive technologies like RFID don t make economic sense for low-value CRT products. 2015 UPS Healthcare Forum 3
Thermal blankets are a low-cost solution for maintaining cargo temperatures, but they must be used properly. Thermal blankets can provide temporary protection for temperature-sensitive cargo, but there is no standard protocol for how they are used. If blankets are not used properly, the greenhouse effect can cause excursions. Companies must work with carriers to ensure that blankets are applied properly. Changing transportation modes in response to weather or other issues can be difficult. One participant noted that they can change routes on truck lanes quickly. However, their air freight forwarder often says the company doesn t have rights to change the route, or alternate carriers or lanes will cost more. Collaboration, as well as temperature monitoring and predictive tools, can help create a more effective CRT supply chain. The roundtable attendees brainstormed several ideas for creating an improved CRT supply chain. Co-sharing assets and infrastructure. Companies that ship CRT products are open to co-sharing. This is expected to increase as more cargo is sent overseas. Chemistry differentiates our products; not the packaging and the shipping. As a result, collaboration with other companies is fine. Roundtable Participant Sharing stability data. One participant noted that conversations about sharing stability data across companies are on the rise. Predictive tools. These tools are valuable since they enable organizations to get in front of shipping decisions. It is critical for companies to know whether they will be able to deliver on time. One organization monitors weather data and postpones shipments to places where delays are likely due to storms. Partnering with integrators. One organization uses integrators to obtain greater flexibility with regard to transportation modes. Some integrators are more mature than others, depending on region. As a result, the company has found multiple partners. 2015 UPS Healthcare Forum 35
Temperature monitoring. Companies use different approaches to monitoring the temperature of their goods. One organization qualifies containers for 72 hours, while another uses continuous monitoring for all international shipments. In the United States, many of the top road carriers now offer online access to temperature monitoring information from their refrigerated trailers. UPS can act as a consultant and improve the cost effectiveness of CRT shipments. For example, UPS developed a program for clients with CRT products in which UPS analyzes weather data for origin and destination pairs to predict excursion rates. If the temperature spikes while cargo is in transit, UPS moves to Category 2 and will apply thermal blankets to the goods. If the temperature increases again, the client s cargo is moved to Category 3 which means a blanket plus CRT storage. This takes the burden off the client and frees them to focus on activities like strategy and business development. 2015 UPS Healthcare Forum 36