How Track and Trace Innovation is Critical for Global Supply Chain Ecosystem

Throughout 2021 Covid-19 vaccines are being shipped from manufacturing to the point of inoculation across the globe. Vaccines contain antivirus agents, antiseptic liquids, sterile water and elements of the DNA of the virus itself that won't cause severe symptoms but trigger the immune system to make antibodies¹. 

Managing the distribution of the Covid-19 vaccine comes with multiple challenges that need to be addressed. These include enabling temperature condition monitoring, real-time location and status of the vaccine, anti-counterfeiting measures, and a centralized command center to monitor the effectiveness and progress of the entire immunization program. 

Honeywell is uniquely qualified to assist companies, governments and supply chain partners in this global effort.  This article reviews just what it takes to safely deliver vaccines and the importance of Track and Trace innovation.

Vaccine Cold Supply Chain

Shipping a frozen Covid-19 vaccine to every corner of the globe is undoubtedly one of the most critical and complex challenges the pharmaceutical and supply chain industries face. 

The rollout of the Covid-19 vaccine, like many other vaccines and pharmaceuticals, requires strict environmental controls. Most vaccines need to be stored within 1 degree Fahrenheit of their ideal temperature. Traditional vaccines are usually stored between 35 Fahrenheit (1.6 Celsius) and 45 Fahrenheit (7.2 Celsius).  And that is no different for the Covid-19 vaccines.  If they get too cold or too warm, they will spoil.²

Some vaccines need to remain calm, while others must stay frozen at arctic-like temperatures as low as minus 122 Fahrenheit (-80 Celsius).  By comparison, some foods like ice cream and steaks are shipped at deep frozen temperatures that easily exceed minus 20 Fahrenheit (-29 Celsius).

If a vaccine shipment goes out of a specified temperature range at any point between pickup and delivery, a $1 million shipment might need to be discarded.

Companies and public health agencies depend on the vaccine cold chain to deliver vaccines to those who need them.  This supply chain keeps vaccines in tightly controlled temperatures from the moment they are made to the time they are administered to a person.

Cold supply chain prepares for Covid-19 vaccine. The cold chain infrastructure includes planes, trucks and cold storage warehouses. As soon as the Covid-19 vaccine is produced, it is immediately transported by truck to the nearest suitable airport. Because the vaccine is precious and time-sensitive, it is shipped via air transport across the country and world. As the planes are unloaded, the vaccines are taken via truck to appropriate warehouse storage facilities for transportation to distribution facilities.

Constant electricity becomes essential as well. In regions where fire risk leads to blackouts or in developing nations where the grid is not as reliable, thousands of vaccines could be lost if the power goes out. Only airports that are certified to handle pharmaceuticals will be able to accept the vaccine. And there are the logistic issues of the airplanes needed to ship the vaccines.³

25% loss of vaccines. A study from 2019 estimated that 25% of vaccines are degraded by arriving at their destination. If the vaccine is exposed to temperatures outside its defined range, and it gets noticed, the vaccines are discarded. The temperature mistakes are primarily due to errors in shipping procedures along the cold chain.  The global losses are estimated to exceed the U.S. $34.1 billion annually. ⁴

Track and Trace Essential for Covid-19 Vaccine

Shipping the Covid-19 vaccine is a daunting challenge of getting the glass vials to every corner of a country and ensuring each dose is kept at the required temperatures. With the Covd-19 vaccine, there has been asserted effort by the pharmaceutical companies, governments, and logistic partners to streamline the track and trace process and use the latest technology to gain real-time visibility.

For example, in the United States, the U.S. government, drug makers and delivery companies worked together to develop a network of monitory devices and detection systems.

Each vaccine box is equipped with a GPS beacon, a temperature monitor and a barcode that is scanned upon receipt. If they deviate from their target destination or if the vials get too hot or cold, officials at the companies and government are immediately alerted to any problem.⁵ Similar plans are being rolled out throughout the U.K. and European Union.

Typical vaccination campaign. Typically, in a vaccination campaign, pharmaceutical companies wait until their product is approved before buying raw materials, establishing manufacturing lines and setting up supply chains to ship a vaccine.  Before this vaccine, Pfizer/BioNTech had never manufactured a vaccine with technology that uses mRNA, the molecular couriers that carry genetic instructions to cells in the human body. This required Pfizer to scale up production capacity before the research was completed. Pfizer/BioNTech began setting up the supply chain in March 2020.¹

Track and trace visibility. Each batch of Covid-19 is given its unique data/barcode as it leaves the manufacture and travels through the cold supply chain. The ability to efficiently track and trace each shipment gives supply chain managers complete visibility. A specific batch is being stored in transit and condition, delivered but not yet used and expiration date. This insight provides better-informed decisions on ordering, distribution, optimizing product flows, storage and returns and helping to avoid vaccine damage and wastage. 

Track and trace for inoculation. Track and trace also become vital at the inoculation level. You can track to whom and when each dose was delivered and following post-vaccination events to record treatment success and side effects. The data can be used by distribution and inoculation centers to effectively plan for a second dosage and related information. In addition, the data helps logistics providers, pharmacies, hospitals and others reconcile stock counts against recorded deliveries.

At this level, track and trace require robust data analytics and an agreed-upon process for capturing, storing and processing data in real-time. The supply chain, however, is large and complex, involving multiple players and geographies. There is a strong need for track and trace to have one set of asset data standardization, taxonomies and data sharing to give the supply chain a common understanding, visibility and compliance.

Real-time monitoring sensors, probs and more. Deploying the vaccine is a huge logistical challenge requiring drugmakers and transportation companies to use various sensors, probes and heat-sensitive labels, and scannable tags with barcodes that follow changes in conditions in transport containers on time and temperature. Temperature-tracking devices are typically used for transporting vaccines, cancer drugs and other high-value perishable shipments.

Single-use tracking devices with temperature and proximity sensor capabilities can provide temperature information at the pallet level throughout the long shipment journey of most vaccines/perishable goods. Turn on the sensor, and vaccines can be tracked in flight, sea, and over the road to their final destination.

As goods cross country boundaries, sensors can be tracked with satellite-cellular communication and are GPS and WiFi capable. These tracking devices communicate with mobile gateways by providing near real-time shipment visibility, which is critical in the cold supply chain.

Through APIs, manufacturers and logistics supply chain partners can receive notifications. If temperatures begin to move toward set maximums allowing action to be taken to preserve the shipment. In addition, real-time monitoring is also used to document compliance with regulatory bodies and governmental directives to prevent loss, contamination and spoilage of critical medical shipments, such as the European Union Guidelines on Good Distribution Practice (GDP) and the U.S. Drug Supply Chain Security Act (DSCSA).

Global Distribution. Pfizer and Moderna have their factories located in the United States and parts of Europe. Storage and shipping the vaccines to other continents will be a significant challenge. ¹²  For example, a large majority of the global population, especially in areas like Africa, Latin America, and Asia, are not likely to have the needed access to special refrigerators needed to keep the Pfizer product at ultra-cold storage.¹²

The Covid-19 vaccines like Moderna and AstraZeneca are the most likely candidate for these regions because of the lower temperature requirements. ⁷ Reaching large areas of the global population will be challenging to reach, especially in intermittent and patch electricity coverage and physical infrastructure. The Global Alliance for Vaccines and Immunization estimates that only 10% of health care facilities in the world's poorest countries have a reliable electricity supply.⁷

COVAX, a program led by the World Health Organization, Global Vaccine Alliance Gavi, and the Coalition for Epidemic Preparedness, pools funds from states and nonprofit organizations to buy and distribute vaccines. COVAX plans to provide a billion doses of coronavirus vaccines to low- and middle-income countries by the end of 2021, covering about 20% of their population.  Those countries with the more significant threat will be first in line.⁸ Access to vaccines within these countries will vary widely. The further away local populations are from the major transportation hubs such as international airports, the longer they will receive the vaccine.

Track and Trace in the Supply Chain are Top Priorities

Traditionally track and trace is a challenge due to the dated paper-based processes and disjointed data systems that have difficulty providing real-time visibility and communication between all entities in the supply chain. The lack of data compatibility exposes the supply chains to problems like visibility gaps, inaccurate supply and demand predictions, manual errors, and compliance violations.

This exposes the goods in the supply chain to ongoing issues related to spoilage/wastage, counterfeiting, contamination, tampering and theft. In recent years, there has been an alarming expansion of the types of products being infringed, from luxury items (such as deluxe watches and designer clothing) to items that have an impact on personal health and safety (such as pharmaceutical products, food and drink, medical equipment, personal care items, toys, tobacco and automotive parts). And no country is exempt. ⁹

The pharmaceutical and life sciences vulnerabilities arise, especially as products and components pass through multiple countries and locations. For example,

·       Because of the gaps in track and trace, it becomes difficult to have a real-time line-of-sight in managing and protecting the vaccine from spoilage and waste. The World Health Organization estimates that more than 50% of vaccines may be wasted globally every year because of temperature control, logistics and shipment-related issues.⁹

·        The influx of substandard/counterfeit medications is more prevalent in low to middle-income countries such as India and Africa. According to the United States Trade Representative (USTR) report in 2019, around 20% of all sold drugs in India were counterfeit.¹⁰

Covid-19 vaccine target for criminal activity. Vaccines face being targeted by criminals. The Interpol global police coordination agency has warned to be prepared for activity linked to Covid-19 vaccines that can include online fraud and cybercrime to theft and the sale of fake or substandard doses. Even empty vaccine vials, which could be illegally refilled, could be targeted. Counterfeit vaccines were a significant public health threat, "ineffective at best, and toxic at worst." ¹¹

Tack and trace is a top priority for Covid-19 vaccine distribution. From governments and manufacturers to supply chain and points of inoculation, Covid-19 track and trace is a top priority. It's a vital step in not only letting manufacturers know where their product is but allows for tracking back to the source of suspicious events.

As sterilized batches of drugs/batches leave the manufacture, they are easily identified and have a clear authenticated chain of custody from pickup to delivery reported through smart, IoT devices and applications. Every party in the drug lifecycle and movement is held responsible for adequately acknowledging these serial numbers and properly registering them from beginning to end.

When anomalies in the product movement occur, they can trigger alerts visible to critical managers and purchasers in the supply chain. These triggers help trace the source of unauthorized intervention, uncovering unsavory distributors and cracking down on counterfeit pharmaceutical scams.

The bottom line, every part of the supply chain wants to ensure that the Covid-19 vaccine is delivered to the right people in 100% safe condition.

Track and trace are fragmented and complex. What is clear is that providing real-time visibility into the pharmaceutical shipments from manufacturer to the point of delivery and inoculation is a mix of paper-based, web-based, digital-based and cloud-based systems. From an electronic perspective, track and trace is a fragmented cluster of software, hardware, device, and technology suppliers, each seeking to garner their slice of the business.  The result is a coalesced semblance of unity for each pharmaceutical application through the supply chain with multiple databases, dashboards and data points that may or may not interface with each other. 

Take, for example, the point of inoculation in the United States.  Every Covid-19 vaccine recipient will receive a vaccination card telling them which vaccine they received, when and where it was administered, and when the next dose is due. The recipients may also be able to opt-in to a smartphone-based survey and reminder system. Immunization records will also be kept in state registries and electronic records through health systems and pharmacies.¹³

Not all state systems are electronically connected. When someone receives their first dose, information could be collected in different ways. Some places might use specialized vaccination clinic software in the early stages: a hospital might use a program that sends a link out to eligible employees who could register for a vaccination appointment. It then sends them a reminder when they're supposed to come in for their second dose. Other health systems, particularly if they're administering shots in-house, might use their patient electronic health records for the same function.¹³

Honeywell Drives Track and Trace Innovation in the Supply Chain Ecosystem

Track and trace for Covid-19 provides for the pharmaceutical industry–including distributors, freight forwarders and logistics providers– to identify and track the chain of custody for vaccines down to an individual vial as they move from manufacturing to the point of injection. For many companies supporting the cold supply chain, track and trace will significantly impact business operations. 

Honeywell understands the track and trace challenges and complexity presented with delivering the Covid-19 vaccine and related pharmaceutical industry supply chain ecosystems. During this crisis, Honeywell has been strategically engaged with our global customer base by helping them successfully react, adapt and manage their course of direction.

At Honeywell, we believe we have a world-class, scalable track and trace solution comprised of our leading-edge hardware, software, barcoding and tracking technology backed by cloud-based central monitoring and command center. This solution helps to dissipate fragmented silos that currently exist in the global supply chain. Imagine the ability to have track and trace solution that

·       Provides one central, secure interactive repository for the supply chain ecosystem to track and trace every step of a product/shipment's movement from manufacture to the endpoint of distribution.

·       Provides a blockchain system for recording information in a way that makes it difficult or impossible to change, hack, or cheat the system.  In Track and trace, blockchain technology can be used to build applications on which multiple groups/parties can transact directly via a peer-to-peer network. This is done without the need for a central authority to verify transactions. Because there is no single network owner, each participant has access to a shared ledger that is unchangeable and cryptographically records all transactions.

·       Guards against the introduction of non-authorized and counterfeit products.

·       Helps identify and enforce which products/shipments have been compromised during shipments, such as exceeding temperature, humidity, light and shock tolerances.

·       Exposes which products have exceeded expiration and shelf-life dates.

·       Exponentially scales to track millions of shipments and billions of transactions daily.

·       Secures the database integrity from cybersecurity breaches.

·       Protects the database from being compromised with unauthorized entry of products/serial numbers for rogue shipments?

·       Provides cybersecurity projection for every API accessing the database that includes the manufacturer and shipping partner to the retailer.

·       Accounts for proper movement through customs with real-time visibility. 

·       Accepts real-time visibility from data collection imputes (e.g., condition, location) from various handheld/mobile devices, satellites and technologies on a global basis.

·       Confirms that products have been registered for appropriate excise tax.

Honeywell is a proven provider in track-and-trace across industries, with its software being used by companies in industries like pharmaceutical, baby food, automotive parts and explosive products industries. Let's highlight just a few of the Honeywell leading technologies that can be included in the Honeywell Track and Trace solution.

·       Industry Leading Mobile Computers. Honeywell mobile computers are based on the Mobility Edge platform. Honeywell Mobility Edge is a leader in Android version support, providing the best available security, features, and lifecycle duration of any ruggedized device in the world. Honeywell is deeply committed to the longevity and quality of the Mobility Edge platform.

Supply chain service providers can deploy Honeywell's ruggedized mobile computers, which can be pre-loaded with the track-and-trace software. Users of the devices can scan product labels, access tracking information and document the movement of goods at every stage. The following products are built on the Mobility Edge platform: Honeywell CT40, CT40XP, CT60, CT60XP, CN80, CN80G, CK65, RT10A, and Thor™ VM1A, and VM3A.

·       Temperature monitoring. Honeywell has a complete line of advanced temperature monitoring labels and technology. For example, the Honeywell BluTag 360™ is a temperature and humidity monitoring data logger. It comes with a dedicated software platform designed, developed and manufactured to cater to the need of customers who require critical parameters to be recorded and monitored when they ship their products from one point to the other and need to comply with regulatory requirements.

·       Barcode Readers. Honeywell barcode readers are plug-and-play with industry-leading scan performance, making even the most difficult-to-read barcodes look good. Honeywell rugged handheld scanners, such as the Granit Series, are encased in impact-ready water and dust-proof housings and specifically built to address common challenges in different vertical markets and environments—outdoors, through washdowns, and rugged mobile jobs. Whether for close-up, arm-length, or extended-range scanning, these scanners fit the demands of track and trace.

·       Honeywell Forge Track & Trace. Governments, law enforcement, regulators and consumers want transparent, reliable and trustworthy 'Track & Trace' related product data. Item serialization and track & trace are compulsory in many industries already. Honeywell Forge Track & Trace addresses the three main drivers: Regulatory Compliance, Supply Chain & Product Visibility, and Consumer Interaction. The data collected at every touchpoint can be integrated into government databases or other applications.

·       Logistics Software Platform. Honeywell has partnered with FarEye, a robust predictive logistics SaaS platform. Honeywell's partnership with FarEye provides a single delivery management solution powered by Honeywell mobile computers and FarEye's intelligent delivery management platform. The partnership empowers enterprises to have complete visibility of goods while transitioning from the manufacturing facility right through to the final destination with seamless integration with multiple data sources across the supply chain.

This means businesses can manage, track, and monitor their delivery operations anytime, anywhere, with real-time visibility to optimize the movement of goods from the first mile to the last mile, improve operations performance in real-time, and deliver a customer-centric experience.

Learn more about Honeywell solutions for Track and Trace. Our teams can work closely with you to understand business requirements, identify opportunities to optimize your workflows and increase efficiencies.

Contact a Honeywell Solutions Expert today! Call 1-800-934-3163.

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Sources:

¹Supply-Chain Obstacles Led to Last Month's Cut to Pfizer's Covid-19 Vaccine-Rollout Target
²The Challenges of Vaccine Cold-Chain Distribution Must Be Met to End the Pandemic
³The Challenges of Vaccine Cold-Chain Distribution Must Be Met to End the Pandemic
⁴International Air Transport Association
⁵The Novel Tracking And Monitoring Technology Getting The COVID-19 Vaccine Distributed Across the U.S.
⁶Supply-Chain Obstacles Led to Last Month's Cut to Pfizer’s Covid-19 Vaccine-Rollout Target
⁷ Over half of vaccines are wasted globally for these simple reasons
⁸Coronavirus vaccine — how to distribute it around the world?
⁹Science Direct: Counterfeit Supply Chains- Zeliha Esera*, Bahar Kurtulmusoglub, Adnan Bicaksizc, Selay Ilgaz Sumerd
¹⁰Over half of vaccines are wasted globally for these simple reasons
¹¹Vaccines for sale on dark web as criminals target pandemic profits
¹⁹With Covid-19 Vaccines Coming, Federal Investigators Grow Wary Of Fraud
¹²Here’s How Health Officials Plan to Track COVID-19 Vaccine Recipients
¹³Multidose COVID-19 vaccines will test state tracking systems