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Evolution in Pharma Cold Chain — Vaccine Vial Monitors to Dataloggers to IoT

Evolution in Pharma Cold Chain — Vaccine Vial Monitors to Dataloggers to IoT

February 28, 2020 - Hari Haran KB

Read Time 8 Mins.

Ensuring product quality when shipping pharmaceutical products is a matter of life or death. This led to the adoption of vaccine vial monitors during the better part of the 20th century, which could provide an indication about major temperature deviations that affected product quality. The industry further evolved in the 70s to use data loggers, which could provide the entire trail of temperature data in shipping. However, today as pharmaceutical companies struggle to balance the constant tug of war between cold chain cost-efficiency and reliability, these two technologies fall short and IoT comes into the picture.

Let’s walk through this technological evolution to understand the pharma cold chain challenges that each of these technologies solved, their cost impact, and why companies are migrating to using IoT for pharma cold chain monitoring today.

vaccine-vial-monitors

Vaccine Vial Monitors (VVMs)

One of the earliest legally accepted indicators of cold chain compliance, Vaccine Vial Monitors are essentially chemical-indicator labels placed on vaccine vials, ampoules, tubes or other types of pharmaceutical products by a manufacturer. It shows the cumulative heat exposure that the tagged product has endured through a gradual and irreversible color change.

The main purpose of a VVM is:

  • To ensure that any vaccines that are heat-damaged do not get administered.
  • To decide if a vaccine/s can still be used after a cold chain break occurs — minimizing unnecessary wastage of vaccines.
  • To help fix the vaccine usage order/sequence — that is, using the batch of vaccines with substantial heat exposure (but still safe to use) before the ones that have had a lower heat exposure (or those that have later expiry dates).
  • To better trace vaccines throughout the supply chain — by checking and recording VVM statuses before dispatch and on arrival at stores and facilities.
PROS CONS

Low-cost, easy to use, and disposable.

Passive logging with no detailed data trails. 

Item-level cold chain compliance validation.

Inability to pinpoint time/location of cold chain breach.

Item-level pharma produce safety validation.

Analog system of reading, which can be relatively inaccurate as well as prone to human error.

 

The biggest caveat of VVMs is that they’re a passive temperature data logging system. They serve as a litmus test that tells you whether the pharma product that they’re affixed to, is suitable for human use or not. While that’s useful, it does little to help efforts toward supply chain optimization because:

  • There’s no clear indicator of when or where cold chain disruption occurs.
  • There’s no early warning capability that could be leveraged to prevent cold chain disruption and reduce inventory losses in storage or transit.

These shortcomings created a need for better systems to track the temperatures and conditions that pharma products are shipped in. This, in turn, spurred the adoption of digital systems that could both comply with increasingly stringent regulatory requirements for public health and safety, as well as reduce wastage as products make their way through pharmaceutical distribution chains.

Companies needed a more fool-proof method to study the temperature activity throughout the journey. This gave rise to the development of the temperature data logger.

temperature-data-loggers

Temperature Data Loggers

Perhaps the most commonplace cold chain temperature tracking solution today, battery-powered temperature data loggers are used to track the temperatures that pharma products in transit are exposed to. Such temperature data loggers are commonly classified into the following types:

  • Passive Temperature Data Loggers — Battery-powered devices that simply log temperature data at set intervals, which can be downloaded using a USB cable for analysis on a computer or hand-held device.
  • Wireless Temperature Data Loggers — RFID or Bluetooth temperature data recorders that are similar to passive temperature data loggers, but with easier data transfer through wireless technologies that make them easier to use in large-scale operations.
PROS CONS

Accurate temperature data trails with detailed digital logs, allowing users to pinpoint the exact time/location of cold chain breach.

Expensive to procure, requires proper personnel training for optimum use, and difficult to recover after shipment completion outside closed loop distribution chains.

Reusable temperature data loggers that are built specifically to comply with stringent regulatory requirements for cold chain logging and reporting.

Temperature data readings need to be accessed in secure temperature-controlled environments and on systems that are compatible with specific data logger brands or types, which limits ease of use.

 

It is still commercially unviable to have a data logger per carton.


Digital temperature data loggers were a significant leap forward from VVMs in terms of accurate temperature data logging. They finally gave supply chain managers the ability to pinpoint areas in their cold chain operations that were high-risk or prone to failure. This allowed them to take measures to reduce risk and overall product losses — especially in transit — which helped improve overall pharmaceutical distribution efficiency as well as offset the costs involved in procuring, deploying, and using expensive digital temperature data loggers that were custom-built to conform with stringent regulatory requirements.

Bluetooth Beacons are also a form of data loggers which enable you to occasionally get down to monitoring at a package-level, however they are still passive systems unless a gateway is used.

Learn How Data Loggers are Different from Bluetooth Beacons.

There was, however, one shortcoming that was yet to be dealt with – the delay in accessing temperature data trails and the inability to know what precisely caused it.

Digital temperature data loggers still needed to be physically accessed in order to read their temperature logs. Although data logs could be used to pinpoint high-risk issues that, when properly addressed, could help reduce overall cold chain risk, cold chain data loggers were still a relatively passive warning system that couldn’t alert users about exceptional situations that inevitably occur in the real world.

Despite being leaps and bounds better than VVMs or other similar passive cold chain temperature tracking systems, temperature data loggers are unable to flag cold chain breaches as they transpire, which means there could still be product damage or loss in transit when pharma shipments encounter situations that were not planned for.

It was this need for an active early warning system for cold chain breaches that led to the development of the next generation: cloud-connected cold chain data loggers or IoT for pharma cold chain.

internet-of-things-with-roambee

IoT

As technology became cheaper and communication infrastructure improved, it became possible to create a connected network of devices that could capture and communicate data in real time — heralding the age of the Internet of Things.

The latest generation of cold chain data loggers benefited immensely from this, leading to the development of temperature data loggers that could store as well as transmit shipment location and condition logs via cellular data networks to the Cloud.

PROS CONS

Live monitoring for pharma product location and condition.

More expensive than earlier generations of temperature data loggers.

Live data streams about shipment conditions can be used to set up pre-emptive temperature excursion early warning systems.

Difficult to recover sensors after shipment completion outside closed loop distribution chains, especially if you are using package-level sensors.

Live data streams coupled with AI-driven data analytics can be used to set up predictive temperature excursion early warning systems.

Need for wireless communication reduces battery life, making long-distance shipments harder to monitor.

Cloud connectivity coupled with easy integrability of inventory management systems, transportation management systems, ERPs, and other Business Intelligence systems can be used to set up automated pharmaceutical cold chain management and exception handling systems.

 

Wireless temperature data access anytime, anywhere without the need to retrieve data loggers, a system that not only improves the ease of use, but also reduces the risk of temperature excursions due to improper inspections outside temperature-controlled environments by untrained personnel.

 

 

Cloud-connected temperature data loggers represent the pinnacle of cold chain tracking and management solutions.

Cold chain risk management strategies can now leverage the power of automation, machine learning, and predictive insights that give pharma manufacturers, shippers, and consumers the guarantee that life-saving pharmaceutical products are transported securely, while also minimizing losses in transit.

The only issues that hold back such systems from more widespread adoption include:

  • Prohibitive Costs — which include the cost of purchasing cloud-connected temperature data loggers, spends on their maintenance, and the inevitable cost of replacing damaged or lost devices.
  • Limited Battery Life — which means long-haul pharma shipments cannot be adequately monitored without recharging or replacing temperature data loggers in transit.
  • Data Deluge — the volume of excursion warnings at scale where one cannot determine whether an excursion needs to be attended to or it will soon normalize on its own.

These three factors weigh heavily on pharmaceutical supply chain managers and other industry players that are eager to adopt cloud-connected cold chain monitoring systems.

While the technological and financial limitations may hinder greater adoption of the latest generation of wireless cold chain temperature data loggers, the workaround is to outsource IoT to someone who can manage it for you.

Outsourcing IoT

Outsourcing cold chain monitoring to your 3PL could hurt you, but outsourcing it to a company that understands IoT, data analytics, and managed services will truly benefit you.

Live location, temperature, and condition feeds are vital to monitor a temperature-controlled shipment’s status, route/carrier performance, as well as to stay one step ahead of the cold chain risks that could disrupt operations. IoT sensors with gateways and Bluetooth-enabled Beacons like the BeeBeacon Sense can monitor live location and temperature down to a package.

Click to download the comparison sheet

It isn’t enough to just have the latest tech in temperature data logging however, not unless you’ve got deep pockets and a delirious level of optimism.

With that in mind, there are relatively simple workarounds to what are perhaps the three biggest hurdles to adopting wireless temperature data loggers and a cloud-connected cold chain live monitoring system.

Limitations of Cloud-connected Temperature Data Logger Solutions

Solutions to Overcome Them with Outsourcing

Cost of Purchase

Don’t Buy, Lease.

By switching from a CAPEX model that puts financial limits on the ability to implement the new monitoring solution as well as tethers you to technology that may have better alternatives in less than a few years, it’s easier to deploy a live monitoring solution throughout a pharma distribution network, all the way down to 3PLs and vendors.

Battery Life

Don’t Stream, Relay.

Rather than relying on the temperature data logger to transmit its own data directly to the cloud via a cellular network, use a system that can relay wireless data logger streams to the cloud via an intermediate access point like a portable hotspot.

An additional advantage of shifting the load of data transmission from the data logger to another access point like the BeeSense is that the data logger requires less power to run, allowing it to work for the entire duration of long-haul international shipments.

Complicated to Set Up & Maintain

Don’t Do It, Get It Done.

Although built with ease of use in mind, deploying cloud-connected data loggers and integrating them with existing Business Intelligence supply chain management and data analytics systems isn’t exactly child’s play. Rather than take on the challenge themselves, enterprises can instead opt to outsource its implementation, deployment, and operation to vendors that are more adept and can do the job at a fraction of the cost (and inevitable complications) of trying to tackle something like this at scale in-house.

An added advantage is that outsourcing relieves enterprises of the complications — and costs — of keeping such advanced cold chain monitoring and management systems updated as well as up and running.

 

Outsourcing cold chain monitoring and management needs isn’t exactly an otherworldly solution — organizations regularly outsource their shipping and supply chain management operations to third-party vendors. Outsourcing allows enterprises to take advantage of their vendors’ well-established expertise, existing infrastructure, and the ability to scale up or wind down engagements depending on evolving business needs.

With that in mind, it’s obvious that outsourcing pharma cold chain monitoring to vendors with a solid solution portfolio and an established track record is the most viable solution.

A cold chain monitoring solution partner can help offset costs, take advantage of constantly improving technologies in the space, and eliminate the long-term risks that trying to set up and manage such solutions in-house entails.

Pharma enterprises that are eager to adopt and leverage the advantages — both operational and competitive — of a cloud-based cold chain monitoring and management solution needn’t have cold feet anymore.

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About the Author:

Topics: real time visibility real-time shipment visibility Real-time Monitoring RFID BLE Beacons Pharma & Life Sciences package tracking cold chain visibility condition monitoring temperature data logger BLE Temperature Sensor cold chain logistics real-time shipment monitoring cold chain monitoring real-time tracking system container tracking system cargo theft warehouse security Warehouse Security Monitoring System cargo security monitoring system Cargo theft recovery RFID Security System End-to-end Supply Chain Security Warehouse Theft Prevention IoT Sensors Inventory Tracking Tracking Pilferage Blockchain in Logistics Blockchain in Supply chain blockchain security supply chain security Benefits of Blockchain blockchain technology supply chain blockchain Cold Chain Monitoring Solutions logistics monitoring system Real-time Temperature monitoring OTIF FTL, LTL, Parcel Tracking Condition Sensitive Cargo Monitoring Pharma IoT In Supply Chain Healthcare Equipment Tracking Cold Chain Data Loggers Temperature data loggers Pharmaceutical Cold Chain

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