Pharmaceutical Cold Chain Monitoring Essentials

Published by Nick Barrowclough on

Cold Chain

Pharma cold chain monitoring technology has come a long way since manual data collection. We now have wireless data loggers that collect data and can automatically synchronize it to a central monitoring platform.

These products have made the collection and storage of data easier, but maybe lack real-time monitoring and alert capabilities. Having a system in place that not only logs data but can pro-actively monitor and alarm when temperature excursions occur is a logical development.

cold chain

What is a Pharma Cold Chain?

Supply Chain + Temperature Control = Pharma Cold Chain

A cold chain is a supply chain for temperature-sensitive products. These could be food, dairy, meat products, or pharmaceuticals such as temperature-sensitive drugs and vaccines. It is important that the cold chain not be broken, as it can lead to damage of the pharmaceutical product, decreased efficacy of vaccines and drugs or pose a public health risk. When the cold chain is broken a temperature excursion may occur, exposing the products to elevated temperatures. These may be OK for a short period of time. Pharmaceutical companies have established a drug stability budget for these excursions.

Temperature excursions are costly events as they can a best lead to delays in delivery of produce while an audit is conducted, and at worse result in the wastage of inventory which can be very costly! Therefore monitoring the temperature throughout the cold chain is vital, and being alerted allows for measures to be taken to preserve the product while still remaining within the drug stability budget.

The most rational thing one can do is find a way to identify and mitigate these risks before a shipment (or patient, and your brand image) eventually pays the price.

Although there are systems to track where a shipment is and what their condition was during transit these are mostly passive systems. This is not enough!

Early Warning Systems vs. Data Loggers

Intelligent data loggers that are connected to a centralized cloud monitoring system with graphing, location and alerts can warn in advance of problems, giving you actionable data and live insights to the condition of the pharmaceutical products in transit and in storage.

pharmaceuticals and temperature

Important Features of an Early Warning System

A cloud-based monitoring system with wireless sensors can track temperature and humidity as well as the location of shipments in real-time while in transit. Know where your product is if it’s been sitting airside waiting to be loaded on a cargo plane, is it getting too hot? Make sure the right information reaches the right person to take action when temperature excursions occur.

Accurate Data

Ensure the sensors being used are accurate, calibrated with NIST traceable certification. The sensor should be capable of monitoring the range of temperatures the package will experience. For some products, a wide range of temperatures and fluctuations is acceptable, for others it must be a much more controlled environment. Having accurate data gives you the proper information that is reliable and actionable.

Package-level Sensing

Sensors should be placed at the package level, especially in breakbulk cargos where packages are separated off into final destinations upon arrival in-country. Package level monitoring is also even more important than bulk monitoring as smaller packages and shipments are much more sensitive to changes in temperature. Also, sensors need to be battery-powered, but use none lithium-ion batteries in order to comply with IATA regulations.

Live & Predictive Data

Data should be visible in real-time for rapid decision making. Of course in certain modes of transport realtime data is impractical, such as when shipping via sea-freight and boats are in the middle of the ocean, or while in the air onboard a plane. The sensors should be capable of logging data while out of communication to the cloud, and then synchronize this information when communications are re-established. As well as live data, predictive data is valuable, if the system can identify a steady increase in temperature, a predictive graph can be drawn and advance warning given of an impending temperature excursion. The system should also support data on the MKT (Mean Kinetic Temperature) to easily identify the degree of damage the pharma products might have suffered during an excursion.

temperature excursion graph

Pharma Compliant

There are many regulations and sensor certifications that surround the pharmaceutical industry. They can vary from country to country. It is vital that you avoid non-compliance as it can lead to penalties and fines. Make sure that your temperature sensors are NIST certified and traceable. NIST certification means the sensor has been tested for accuracy and has been calibrated for the given range of temperatures specified on the sensor.

It is also important that your document management system which stores and retrieves the sensor data is compliant with 21 CFR Part 11 with regards to data storage and digital signatures.

FDA 21 CFR Part 11 Compliance

Conclusion

Going digital with your pharma cold chain monitoring solutions will be beneficial to your business in the long run. It goes beyond saving cost with spoiled pharmaceutical products, but also strikes at the efficacy of the drugs and compliance with regulations. Most importantly it protects human lives from being put in danger by using non-effective vaccines or drugs.

In short, the old-style data loggers only give you limited information and are reactive rather than a proactive solution. Pharma-mon provides a complete range of products to monitor your pharma cold chain, medical refrigerators and warehouses.

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