Cold chain logistics must be clear, robust, and nimble to address challenges that arise, including equipment failure, deviations in conditions, and unforeseen delays. It is vital for companies that deal with temperature-assured handling and distribution of products such as perishables, chemicals, vaccines, and drugs.
Temperature consistency is imperative to ensure quality and safety as these products are exposed to a multitude of environments during production, packaging, distribution, and on/off-site storage. But maintaining temperature consistency can be tricky.
In one study conducted by global logistics company UPS in conjunction with TNS, investigators found that roughly 30% of international pharmaceutical shipments experience some degree of spoilage, or are wasted or damaged before getting to their destination. These are major problems for the $73.3 billion global pharmaceutical logistics market.
Enter cold chain monitoring, a crucial step in ensuring the quality and integrity of temperature-sensitive products from manufacturing to consumption and each step in between. If you’re dealing with regulated products like pharmaceuticals, cold chain monitoring is perhaps your best bet at ensuring regulatory compliance.
Keep reading to get the low-down on cold chain monitoring.
What is a Cold Chain?
A cold chain is essentially an unbroken temperature-assured supply chain, so that products are kept in temperature-controlled environments at all points during the production process, shipping, storage, and distribution. It’s essential to make sure the quality, purity, safety, and integrity of products are not compromised.
For example, Covid-19 vaccines like the one offered by Pfizer and BioNTech require that storage and shipping temperatures be kept at around -70°C. Even after the FDA reviewed temperature requirements for these vaccines earlier this year, they must still be stored at temperatures between -15°C and -25°C for no more than two weeks to maintain their efficacy, as highlighted by the BBC.
It is important to note that ambient temperatures and other environmental parameters (e.g., pressure, humidity, etc.) must be continuously measured, monitored, and documented in all areas of the cold chain supply. This is why cold chain monitoring plays an important role in vaccine serums.
What is Cold Chain Monitoring?
The name says it all — cold chain monitoring encompasses observing, collecting, and documenting temperature data of a cold chain over time. It’s typically needed to ensure temperature consistency, protect assets, and meet regulatory compliance.
As with any monitored system, the cold chain involves a series of processes, actions, equipment, and technologies to maintain an uninterrupted refrigerated supply chain. You can look at cold chain monitoring from many fronts:
A cold chain can employ many different technologies to maintain, monitor, and document temperature-controlled environments throughout the supply chain from a technological standpoint. These principles and technologies often include:
- Compressor cooling and heating (temperature systems)
- Data logging and transmission (using temperature sensors & wireless data loggers)
- Phase Change Materials (PCM)
- Centralized data storage and access software/tool
- Insulation technologies
- Digital temperature measurement
- AI, machine learning, big data, and other nascent technologies
- Cloud infrastructure for storing and managing cold chain monitoring data
You can also view cold chain management through process lenses. In which case, many tasks and actions must be taken to produce, package, store, ship, and monitor temperature-sensitive products along the whole cold chain. Therefore, each step in the cold supply chain must stick to predetermined processes — most frequently referred to as SOPs (Standard Operating Procedures). These include:
- Avoiding exposure to out-of-range conditions
- Using the correct equipment for monitoring, transporting, and packaging products
- Delivering products on time (avoiding delays that may compromise product quality and alienate client trust)
- Adhering to a defined release process, usually followed when the products reach their destination.
How Does Cold Chain Monitoring Work?
As the name suggests, cold chain monitoring involves measuring, recording and documenting environmental parameters, predominantly temperature, throughout the cold supply chain. Data loggers are typically used to keep track of temperatures and other conditions in production areas, packaging workstations, shipping containers, point of delivery, and anywhere else that is part of a cold chain.
Let’s take a closer look at the most critical areas of temperature-controlled logistics:
Environmental data logging and cold chain monitoring are crucial at the point of manufacturing to ensure the safest and highest quality product production. In highly regulated industries like pharmaceuticals and food, this is a critical step to complying with federal regulations and passing audits.
The FDA, USDA, EPA, and other government agencies routinely audit organizations in these industries to protect consumer safety and ensure compliance. For instance, vaccine production must be monitored strictly to guarantee safety and efficacy. That’s because even slight temperature fluctuations can degrade ingredients and render vaccines ineffective, leading to vaccine wastage and spoilage.
Distribution and Storage
Monitoring the distribution and storage side of the cold chain is an indispensable part of temperature-controlled logistics. As vaccines, drugs, and foods are shipped, temperature fluctuations can occur. Thankfully, with the use of data loggers, temperature monitoring during distribution can be customized to match the needs of your specific products.
Today’s digital data loggers are compact, pre-calibrated, waterproof, and disposable. This provides organizations with increased convenience for monitoring their cold chain in a multitude of environments.
According to Dickson, digital data loggers can be fitted to wirelessly upload temperature data to the cloud. From there, collected data can be accessed anytime and anywhere with just a simple click using any internet-connected computer, tablet, or mobile device.
Cold chain monitoring data can be analyzed, visualized, and (if necessary) validated. Additionally, data loggers can be set up to send out alerts or signal alarms when temperatures go out of range.
When it comes to receiving cold chain deliveries, different retailers and end-users have different needs and preferences. The customized temperatures of products must be monitored, and deviations remedied immediately at this point of the supply chain.
Traditional temperature-controlled logistics face a laundry list of challenges regarding visibility, capacity, capability, and cost-efficiency. These limitations hinder their ability to detect and react to cold chain problems. Deploying effective data loggers and cold chain monitoring systems can ensure temperature consistency, improve logistics visibility, and enhance operational efficiency of the cold chain.