Evolution in Pharma Cold Chain — Vaccine Vial Monitors to Dataloggers

1. Evolution in Pharma Cold Chain — Vaccine Vial Monitors to Dataloggers 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 (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.

2. 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 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.

3. 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. 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.

4. 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. 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,

5. 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. Visit https://www.lisalineasia.com/ for Vaccine vial monitors, Cold Chain management, Cold chain Technology, Cold Chain Solutions, Cold Chain Monitoring system, Cold Chain System, Cold Chain Services, Cold Chain sensitive products India, Cold Chain temperature indicators, Innovative Cold Chain technologies, Temperature Data Loggers, Cold Chain Equipments.