Real-Time Cold Chain Monitoring

There is a lot that can go wrong during transportation given the unforgiving conditions goods and supplies sometimes face. Statistics estimate around 20 percent of pharmaceutical freight is damaged in transit.

Without a proper strategy in place, business owners risk hefty financial losses and, most importantly, the loss of integrity and customer trust. Real-time monitoring enables instantaneous reporting, giving one the opportunity to react before a product is damaged.

Without real-time monitoring, the cold chain was different and exhausting. First, suppliers had to establish which goods were damaged and have them discarded. An extensive analysis that could take weeks to months to determine the root cause. Then, the team would formulate procedures to prevent or minimize damage in the future.

Today, thanks to technology evolution, suppliers can have full visibility of their products regardless of location, ensuring better shipments.

Real-time monitoring is all about being proactive: using real-time data to identify anomalies and mitigate risks. Visual inspection upon arrival is still good, but with real-time monitoring, data is able to make quality decisions during and after the journey.

Real Time Cold Chain Monitoring

What Is Real-Time Monitoring?

Real-time monitoring is the delivery of continuously updated data at zero or low latency. Getting data in real-time provides the opportunity to respond to problems right away to reveal and predict trends.

Take, for instance, unique samples that require freezing temperatures to stay viable. If the temperatures fluctuate to alarm conditions in transit, one is likely to lose precious specimens. On the other hand, having the right real-time temperature monitoring system will help save the samples. The warning signs are always in the data, so one can see it coming.

With advancing technologies, real-time monitoring can be part of a network of interrelated computing devices collecting and sharing data without the help of human interaction. This type of system is known as the internet of things (IoT).

Real-Time Monitoring Technology

Learn the history of real-time technology, how it works today, and what's to come.

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Real-Time Monitoring Benefits

Maximize profits by preventing goods from being damaged. Here is how it’s done:

o Instant alerts. Estimate the situation’s severity and what can be done to save products. A slight temperature change will alert the monitoring system, which will in turn send a notification.

o Accuracy. Eliminate the risk of human error due to the fast and reliable automated processes of collecting data independently

o Customized indicators. With the right real-time temperature monitoring system, it’s possible to customize indicators based on product types at any time.

o Automation. Processes at sender and recipient can be automated (automated start, automated stop, automated upload). Manage the supply chain more efficiently.

o Reports and analytics. A real-time temperature monitoring system automatically generates reports, which are essential in analyzing trends and designing new measures. This data can be used to predict trends over time and recognize malfunctions before the situation becomes critical.

o Asset location tracking. Using real-time temperature & humidity monitoring sensors providing temperature/humidity and position in the same device, offers new opportunities in asset location tracking. Logistics Service Providers can offer a higher service level (proactive intervention) resulting in less stability budget waste and product loss. Furthermore, they can use available information to manage fleets more efficiently.

o Accessibility to data. Information is available wherever there is internet access to anyone who has an established account. Gone are the days when one had to call or manually ask for temperature readings to stay updated. With a real-time temperature monitoring system, one can keep track of temperature fluctuations throughout the supply chain without the need to retrieve data loggers, install software, or train personnel in uploading files.

o Reduce administrative costs. Aggregated temperature/humidity and position data can be used to improve the cold chain and reduce cost (heat-maps, insurance cases).

What to Look for in a Real-Time Temperature Monitoring System

User-friendliness. Not everyone is tech-savvy. That said, always opt for an easy-to-understand monitoring system. It should also be easy to set up, troubleshoot or debug, and seamlessly adapt to change.

Battery life longevity. As it monitors and stores information 24/7, monitoring systems must have long battery life avoiding the risk of data loss.

Storage capacity. Real-time temperature monitoring systems track shipments over weeks or even months. Thus, the system will need enough storage to hold that data.

Wireless data transfer. For a real-time temperature monitoring system, wireless data transmission is a must-have. The system should transmit data in a timely fashion to allow for a quick reaction and response from the team. Wireless data transfer is exceptionally robust when combined with a cloud-based data storage system.

Package-level monitoring. Sometimes, packages may spend time outside the defined temperatures, or for longer than the duration of the shipment. This is why it’s essential to attach the hardware to every package for seamless monitoring of all containers.

Over-time temperature data. Over-time temperature data helps one make informed decisions. From disposing of batches to opening a dispute, this is a crucial source of product information.

PDF Data Loggers vs. Real-time Data Loggers

Market Authorization Holder (MAH) of time and temperature sensitive biological products have to monitor one shipment or multiple steps in the supply chain. They have typically done this by using PDF data loggers – a proven low cost technology to monitor temperature during cold chain shipments and document the release decision. Consider the following pros and cons when thinking about real-time data loggers:

PDF Data Loggers

PDF Data Logger

Timing of intervention: Reactive – A deviation is only found after a shipment has taken place (no proactive actions possible).

Safety and reliability: Start and stop flags must be set manually (usually by button). Loggers must be retrieved from the handling unit, and the upload is performed manually. Manual processes are prone to error.

Corrective Action & Preventive Action (CAPA) from big data: A traditional data logger can collect data (including temperature, location of origin and destination), but it does not record the location throughout the supply chain, which means the location in which the temperature deviation occurred is likely unknown.

Structure and cost: PDF USB data loggers are available as single-use devices at less than $20 in large quantities. Within the same company, they can be used in many different ways, adapting to the required specific process (e.g., with or without database).

Real Time Data Loggers

Timing of intervention: Proactive – The logistics service provider (LSP) is notified before a deviation happens. This will result in less waste of stability budget and reduce product loss.

Safety and reliability: Processes at sender and recipient can be automated (automated start, automated stop, automated upload). Error-prone processes turn to robust, safe, and reliable processes.

CAPA from big data: The performance of the LSP can be summarized through the collected data. Aggregated temperature and position data can be used to improve the cold chain and reduce costs (heat-maps, insurance cases).

Structure and cost: Real-time data loggers are significantly more expensive than PDF data loggers. They need a more structured/central/uniform approach since all configuration and evaluation takes place in the central database.

Security

No matter what technology is used to collect temperature data or monitor shipments, some sort of hardware and software will be outside of your direct control. If you work with a device where a computer is used to generate and upload the PDF report, or if you work with a real-time device connecting to the cloud, data is secure through encryption. Therefore, data integrity is assured.

Cold Chain Monitoring

For real-time devices working with a public network, the security efforts start with designing the devices at maximum-security levels including encryption. In addition, the network provider can encapsulate the data stream via Internet Protocol Security (IPsec) tunnels or Multiprotocol Label Switching (MPLS). In this way, the public network becomes a quasi-private network and enables a secure connection in a shared infrastructure with logical domains. The most important security measure, however, is the confirmation. Only after confirmation that the data has arrived in the cloud with the right checksum, the data logger will disconnect– otherwise it will keep on pushing the data in its original form.

In summary, PDF data loggers and sensors have the advantage of low-cost hardware allowing flexible set-ups. However, this option is reactive as finding a deviation is only possible after a shipment has already been completed. Furthermore, although data aggregation is possible, one might never know when a deviation occurred, or where the consignment has been. PDF data loggers might be an affordable option for less demanding products, but not the best for critical supplies. In much the same way no grocery would sell unrefrigerated meat or expired cartons of milk, no patient should receive substandard quality and possibly life-threatening drugs. With so many hands handling products, the risk of human error is great. Fortunately, there is a solution that can help with this. Real-time monitoring systems guarantee supply chain visibility and product security. Unreliable manual processes are eliminated. The shipper has control of the processes and can continuously improve the cold chain. MAHs will typically choose a mixed approach shipping the less critical products on less risky trade lanes with PDF data loggers, and using real-time devices on the rest.

Applications of Real-Time Data Loggers

Cell and Gene Therapy and High Risk Shipments

When shipping high-value, sensitive biopharmaceuticals, temperature and time is of the essence. Due to the high value of the products, loss of product due to temperature deviations is not an option.

Requirements for Real-Time Tracker:

• Compliance in temperature monitoring

• Zero deviation due to real-time intervention

• Combine real-time device with traditional PDF USB data logger for less critical products/shipments

Asset Location Tracking and Compliance

LSPs owning and operating fleets of cold chain equipment (containers, multi-use boxes, trucks & vans) must provide compliant temperature monitoring. Traditionally, LSPs used logistics trackers to monitor locations of shipments along with temperature monitoring data loggers. These are put in place by the shipper or sometimes offered as an add-on. Smart LSPs have combined the functionalities into one device, increasing operational efficiencies, and saving cost.

Requirements for a Real-Time Tracker:

• Monitor temperature, position, and other parameters (e.g., heat, light, tilt, humidity)

• GAMP 5 validation

• Battery life of >1 year

• Capable of integrating data into third-party asset management solutions

Complex Global Supply Chain

Many large pharmaceutical companies have a mixture of products, shipping modes, and packaging methods. Shifting all their monitoring devices from PDF to real-time is not an option due to cost and complexity. They want a temperature-monitoring database, which offers all options in parallel: real-time trackers, PDF USB data loggers, and low-cost box-level indicators.

Requirements for Real-Time Tracker:

• Real-time capabilities with end-to-end global visibility and control

• Compliance in temperature monitoring

• Combine real-time device with traditional PDF data logger for less critical products/shipments and box-level indicators

• Simple and intuitive

Clinical Supply Chain

Clinical trials are often shipped to remote destinations where the responsibility for the product is not handed-over to a customer or recipient, but it remains with the product owner. In such situations, data loggers with a battery-life of up to 2 years are used to monitor the shipment, release the product at destination, and follow the product into the local storage or refrigerator. The data archive and alarming must be under central control.

Requirements for Real-Time Tracker:

• Monitor products during shipments

• Safe and easy release at destination

• Follow the product into remote warehouses and refrigerators

• Keep on monitoring the product during storage at remote site

An Integrated Approach to Real-Time Monitoring

Installing a reliable monitoring system alone won’t suffice. A more comprehensive approach involves the following:

Education and Regulation

Before a product enters the supply chain, there should be a designated logistics team and clearly defined standard operating procedures. Additionally, management should facilitate thorough training for the team.

Packaging

Pharmaceutical shippers are 100 percent responsible for packaging. First, they should test the packaging for distribution stresses, such as vibrations and drops, and then for temperature sensitivity. Detailed instructions regarding sensitivity and other transportation conditions to be observed is critical to proper product handling.

What are my cold chain monitoring requirements?

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