Transporting CRT Medicines in 2019: Part 2
To read the Part One of our CRT report, CLICK HERE.
When the EU GDP standards were established in 2013 expanding temperature-control compliance requirements to CRT products, the first reaction of many companies was to apply the same technology as refrigerated containers—insulated boxes with gel packs. However, not only is it more difficult to keep a product at room temperature (because of the mass of PCM material necessary) than a refrigerated product, (whose PCM can pack more cooling into a given mass), it can also bbe significantly more expensive. Considering that, at least according to some estimates , 90–93% of drugs in the market are CRT (10X the size of the cold chain market), if companies were to leverage the same insulation solutions, technical practices and devices to transport CRT drugs that they use for cold chain products, the cost would be staggering.
Pharmaceutical Commerce’s Sourcebook estimates that logistics costs for cold chain drugs will increase to $16.6 billion by 2021, 24% higher than they were in 2017. As they explain, part of this growth will be due to increased spending on CRT shipping. In fact, 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. In addition, 2019 Cold Chain Global Forum speaker Vadim Klyushnichenko, VP Pharmaceutical Development and Quality, California Institute for Biomedical Research, told us that their CRT logistics costs have gone up by as much as 10% over the past year.
Though there is a trend toward more spending on devices and system for controlled room temperature (CRT) shipping, to date, most of this involves more careful monitoring of shipping conditions, and greater use of temperature-controlled transport vehicles, and not necessarily extensive use of insulation or other environmental controls, according to the 2017 Pharmaceutical Commerce’s Sourcebook.
So how are leading-edge companies protecting CRT products without breaking the bank?
Passive Containers & Thermal Blankets
Considering a deploying a single refrigerated truck can cost about $60K, many supply chain leaders are turning towards more simple and cost-effective solutions such as thermal blankets and passive containers for CRT shipments.
Both thermal blankets and standard insulated containers offer multi-tiered and customizable insulation and protection from temperature excursions. As an added bonus, since many of these solutions can be re-used, they have the potential to deliver long-term value. Though they might not be appropriate for products with tighter stability budgets or for long journeys through extreme temperature, they do offer a viable alternative to more resource heavy transportation options.
Know Your Product Part II
After years of actively collecting data around this issue, the industry has a better understanding the stability of time and temperature-sensitive drug products than ever before. In many cases, they’re finding that products are more thermally robust than previously thought. In fact, the current USP temperature range for CRT is very narrow and does not take into account expanded drug product stability data. Unfortunately, this tight temp range can lead to perceived shipping excursions, costly investigative responses and the unnecessary disposal of viable products.
To combat this issue, aim to generate stability data that can support labeling products with a wide temperature range that encompasses typical excursions encountered when shipping products, including pharmacy mail order distribution and the patient in-use period. USP also recommends that both the primary packaging and the case labels list both the storage conditions (and distribution conditions if different) and typical excursion temperature data (i.e. store below 30°, excursion to 40° for 1 month).
Learn More about maximizing the security, safety and efficiency of CRT products at the 2019 CCGF! Below is a snapshot of some of the CRT-oriented sessions we have in store for you this October.
3:00PM on Tuesday, October 15, 2019
WORKSHOP D: Looking Beyond the Cold Chain: Preparing your Supply for Increased Vigilance of CRT Products
With regulators across the globe becoming increasingly interested in how organizations are controlling the variables when distributing CRT/Ambient products, companies must re-assess their processes to ensure compliance. Even if total temperature monitoring is not required by regulators, it is crucial to show that you have strong processes in place to stay off their radar. Regulators want to see that you have your documentation in order for these products and have a full understanding of your transport process.
From this workshop you will walk away with insight on how to:
- Calculate accurate temperature profiles for ambient products and properly analyze data collected
- Understand the environment where your products will be traveling and how to best control the elements
- Define your routes through qualification & validation of shipping lanes and profiling using historical data
- Pinpoint the packaging required to seamlessly ship ambient products globally and where a more custom design is needed
- Discuss the global GDP landscape for CRT products and where your products get flagged more often
8:45AM-5:00PM on Wednesday, October 16, 2019
Sonoco Thermosafe Master Class: Certification Program- Life-Cycle Development of Temperature Assurance Packaging (TAP)
The certification program is a one-day, interactive training course designed to guide participants through the process of developing Temperature Assurance Packaging (TAP) solutions from beginning to end. Topics to be explored include: regulations, transportation/logistics, ambient profiles, operations, and package design. The course is conducted by a diverse team of industry experts who will provide handson instruction with a case-study based learning environment. Certified Professionals will be able to:
- Understand the fundamentals of temperature assurance packaging
- Evaluate different solutions to determine what best meets the needs of their company
- Guide the implementation of temperature assurance packaging solutions within your organization
- Grasp the key processes, protocols and techniques involved in designing temperature-controlled packaging
1:00PM on Thursday, October 17, 2019
Interactive Discussion Group: Creative Solutions to Cost Effectively Manage the Transportation of Ambient Products
- Assessing how the changing regulatory environment will impact what’s required for transportation
- Working with stakeholders and legislators
Presentation by John Janczy, Head of Research & Development, Nanoly Bioscience