Temperature-sensitive products are hard to manage. Even more so when talking about biologic packaging: that involved with cells, tissues, and organs.[hr]
Recently, Packaging World published an interview with Mike Rice, President & CEO, BioLife Solutions, Inc., about temperature-sensitive biologic packaging trends. On discussing current market capabilities, Rice lamented a widespread use of a “‘validate then assume’ approach, where minimal assessment of true post-delivery viability and functional performance of biologics is completed”. In his view, seasonal changes in ambient and the need for cell-based products to recover from cold storage before use should be taken into account, but aren’t.
Progress is being done, however. According to Rice, the answer is disruption:[hr]
“Innovation has been incremental over the last few decades and opportunities exist for disruptive technologies to displace traditional suppliers.”[hr]
The new trends could come from regenerative medicine, drug development, or findings in seemingly unrelated fields, such as cloud computing, apps, mobile electronics. SAVSU Technologies’ evo™ Smart Shipping Container recently won a 2015 Medical Design Silver Award for combining long-range temperature stability with an integrated wireless communication system.
Users, according to SASVU, can “access data such as payload temperature, exact location, humidity and shock and vibration as well as set up alerts if the shipping criteria are not being met”. How so? With an app, of course. Rice pointed to BioLife’s cloud-hosted “cold chain” management app, which provides users with the capability of “pack out, ship, track, and monitor high-value biologic payloads during transit to the destination.”
Monitoring temperature in the shipping containers is extremely important: without effective preservation technologies and containers, biologic materials degrade and die. Cold is used to slow metabolism and the need for oxygen and nutrients. Rice explained this process:[quote]Hypothermic (refrigerated) and frozen (cryogenic) temperatures can enable an extended out-of-body/culture-conditions time interval, but the exposure to cold temperatures itself can damage biologic materials. Our preservation media products are engineered for low-temperature biology (…) thereby improving post-preservation survival, and more importantly, functional performance.[/quote]
Other shipping companies, such as BioStorage, have also been very concerned with proper biological shipping and temperature monitoring. Some of the factors they also have in mind are labeling, documentation, monitoring devices, and proper training. The U.S. Department of Transportation (DOT) and the International Air Transport Association (IATA) also require training of individuals and organizations in order for the biological materials to be handled properly. Even DHL has a policy for biological shipping.
After all, the penalties for diverse violations of the Hazardous Materials Legislation range from $500 to hundreds of dollars. Would you risk it?