The above word cloud is feedback during a live polling of participants of the 2019 Leading Minds New Jersey seminar, answering the question “What themes do you want to hear at this seminar?”.
INNOVATION is on the minds of all practitioners in temperature control life sciences distribution. The promise of technology is exciting. The possibility of saving millions in bad shipments is irresistible.
Over two days, practitioners exchanged ideas and their experiences across topics including:
Leading Minds Seminars are largely discussion-based, unique in format and intent: we call it FUELS (Fusion of Useful Experiences in Logistics and Storage). Learn about upcoming seminars in your area.
Moderated by Geoff Glauser, with input from Tom Scalone and audience.
The group agrees that using stability budgets is inevitable but even more so important in order to save cost and improve efficiency in the process. One of the major challenges is to push forward the remaining stability downstream in the supply chain. The group have addressed the following challenges:
All of this is a software challenge and the group agrees that it can only be solved by integrating the cold chain database with the ERP (typically SAP).
The discussion continued and new questions came up if local authorities are accepting the use of stability budgets, including:
One important take out from the stability budget discussion with regulators is to have a realistic view on the sensitivity of your product. A 2-8°C product for example, which is not sensitive to freezing is much better shipped at a lower temperature setting than at strict 2-8°C (since exposure to heat is much more dangerous). By doing so, you might be able to safe significant money (e.g. by using low cost dry-ice cooling containers vs. expensive "strict 2-8°C packaging"). Key lesson: Make sure to include freeze/thaw cycles into your stability data early in the process.
Presentation and discussion led by Lisa Moher.
Lisa has showed an innovative system how to perform local US shipments in a validated process and container without adding temperature monitors to each single container. The process includes a qualified box based on seasonal temperature profiles (origin & destination) which is used in a validated process using a daily weather forecast email for the operations personnel to decide on the packaging. The entire process is validated regularly by qualification shipments proofing that the process works - in these qualification shipments, data loggers are added to a minimal load and the data is collected in a database. FDA has audited the process and did not have major findings. So, Sanofi is using this process today for all local shipments. Lisa explains the cost benefit as follows:
Feedback from audience was extremely positive. However, some pointed out that ‘not monitoring’ is not possible for higher value shipments, for example losing one shipment could result in higher lost product value than the 9 Mio $ spent on data loggers. Lisa advised this is the same case for US, where non-last mile shipments are shipped at label claim and monitored.
Another consideration is the "no monitoring" process works perfectly in domestic last-mile but it does not work on intercontinental shipments, on high-risk lanes and if the product needs to be re-shipped, as pointed out by Lisa.
One of the discussions then taking place was about the load in qualification shipments. The group agrees that every additional product box added to a container increases the thermal mass and therefore minimum load is the worst case you should test in every qualification shipment. An empty shipment is the "worst case of minimum load" and therefore probably the safest bet.
Discussions led by: Gordon Johnson, Jeroen van Loo, Bill McGillian, Martin Peter
It’s clear, the industry is moving to real-time monitoring. Or actually is it wireless or "hands free" technology that is needed? These are the discussions the group at Leading Minds had.
What problems can IoT solve?
What problems could IoT create?
Group’s conclusions and key learning points
The ultimate dream
Following discussions on requirements, limitations and realities, the group discussed what would the ultimate solution be in the future, in terms of hardware and overall wishes. They included:
However, the group is well aware that at the moment this ultimate dream is not possible due to cost, size and battery. "But who knows what will be possible in 5 years?"
Today ELPRO uses various wireless technologies to automated processes and upload data directly to the database to achieve “contactless real-time monitoring”, including Bluetooth and GSM devices.
But the “intelligence” isn’t just in the hardware. Rather it’s in the software that uses sophisticated workflows that adapt to specific situations, or specific products for release under certain conditions. For example, consider 5 different drugs, each with a different set of stability budget. How is the remaining stability budget inherited to the next transport step? The software needs to b organized in way monitors, assesses and releases products; not shipments.
For last miles, especially high value products e.g. biologics, personalized medicines, gene therapies, Direct to Patient, etc. – LIBERO ITS has been a valuable solution that is small enough, cheap enough, thin enough and smart enough to go sales unit level and monitors the entire supply chain from filling to patient. Read more about LIBERO ITS here including technical specifications and solution video. Or if you are in clinical supply, don’t miss the white paper describing use cases of LIBERO ITS for clinical supply chain Direct to Patient distribution. ELPRO and Sonoco ThermoSafe were delighted to host such an interesting meeting of the minds, collaborative seminar.