Vaccine Vial Monitors (VVMs)

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.

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To decide if a vaccine/s can still be used after a cold chain break occurs — minimizing unnecessary wastage of vaccines.

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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).

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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 Analog system of reading, which can be relatively inaccurate as well validation. 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.

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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.

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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.

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.

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