Vaccine Vial Monitors and digital Data Loggers with IoT solutions are an important part of the distribution of temperature-sensitive pharmaceuticals. Ensuring the efficacy of vaccines is a serious matter. Apart from the risk that a vaccine (or drug) could be dangerous if not stored correctly if the efficacy of the pharma product is decreased it could lead to infection of a person who was thought to be immunized. Vaccine Vial Monitors have been around a while. They can provide the medical professional who will administer the vaccine with an indication if the product has been exposed to major temperature deviations.
An improvement on this was to implement the use of data loggers. These provide an audited trail of the temperature during shipping. Today, this has evolved into live tracking, data logging and monitoring during transit and during storage. This is where the Internet of Things (IoT) comes into play.
Let’s In this article we will walk through the technological advances made in this industry, analyze their impact and challenges of each and why companies are increasingly moving to an IoT platform for their monitoring needs
Vaccine Vial Monitors (VVMs)
These were the first legally adopted indications that the cold chain had not been broken. They are a chemical indicator label that is affixed to vials, ampoules, tubes or any other type of temperature-sensitive pharmaceutical product. The label will change color based on its cumulative heat exposure. This provides guidance to the medical professional who shall administer the vaccine or drug as to whether there has been a significant temperature excursion.
|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 main drawback for VVMs is that they are a passive monitoring of temperature data. They provide a safety net to ensure temperature compromised drugs are not administered, but they provide no useful information for the optimization of the supply chain. They do not provide you data as to when or where the excursion occurred, and there is no advance warning of the developing situation that could have allowed for corrective action.
These drawbacks pushed the industry to look for a better solution and created the demand for systems that can track the temperature and storage conditions of pharma products during shipping. As digital systems became more common place it was an obvious choice to adopt a technological solution. In addition increasingly stringent regulatory requirements being placed on the pharmaceutical industry mean a solution was essential.
There was a need to not only monitor the storage temperature, but to have an audited trail of the conditions throughout the products journey. Enter the data loggers.
Watch this video on how to read a Vaccine Vial Monitor (VVM)
Temperature Data Loggers
These are the most common device used in cold chain temperature tracking. They are compact, battery powered digital temperature sensors. From when they are turned on they will log temperature data, store it internally and then you can download it later. They will provide you a completely audited, time stamped data trail of the temperature conditions during transit.
They typically come in two versions.
- USB Stick type. These require you to physically collect and connect the device to your computer or hand held device and download the data.
- Wireless temperature data loggers, using typically using Zigbee or Bluetooth technology. They make it easier to transfer the data to your computer or handheld device.
|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.|
These digital temperature data loggers were a significant advancement from VVMs. They provided a complete record, with accurate data points that could be analyzed. Cold chain industry could begin to identify “excursion points” – areas within the supply chain that temperature deviations commonly occurred. This allowed for action to be taken to reduce the risk at these points in the process. This improvement meant less risk to public health and spoilage of products. This improved efficiency of pharmaceutical distribution.
These systems, however, were still passive, although an improvement to VVMs, there was no pro-active monitoring that allowed for alerts when temperature excursions occurred. Digital temperature data loggers still require you to physically access them in order to read the data.
As the later part of the 20th century came, technology advanced at a rapid pace, and became much cheaper. Communications infrastructure was improved significantly. The advent of the internet allowed for almost instantaneous transfer of data from one location to another. There began to be formed a network of connected devices which heralded a new age in terms of communication. This became known as the Internet of Things (IoT).
This technology was leveraged in the cold chain management and monitoring industry. Particularly for pharmaceuticals and temperature sensitive products.
Digital Temperature Data Loggers became more intelligent and connected. GPS systems allowed for live tracking of a shipments location. Database systems were able to process and store huge amounts of data “in the cloud”. However i was the need for an early warning system that drove the development of the next generation of pharma cold chain monitoring systems.
These cloud-connected monitoring devices provide realtime data on the cargo. It’s location, temperature, humidity, even if it’s been roughly handled.
|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.|
These cloud connected temperature data loggers are the pinnacle in cold chain logistics management solutions. Pharmaceutical companies and cold chain logistics providers have been able to utilize these systems to give predictive insights as to when a temperature excursion is likely to occur. This investment in technology has a payback in decreased wastage of pharma products, increased quality control and easier compliance with regulatory requirements.
It’s all a bed of roses however, there are still drawbacks to this IoT data logger and temperature monitoring system.
- Cost – the initial investment in the technology as well as ongoing operational costs. Cloud storage fees and the cost of connection across borders via cellular networks. There is also the cost of replacing lost and damaged devices.
- Battery Life – for long haul shipments battery life can be a problem. Pharma-Mon has addressed this using carefully designed hardware and software to ensure ultra-low power consumption and up to 10-year battery life.
- Data Overload – where too much data is provided, false alarms and so on. It is important in these monitoring systems to avoid unnecessary alerts so the actual emergencies can be attended to.