Manual for Cold Chain Monitoring During Transport

Cold chain logistics makes the world go around with the help of cold chain monitoring to prove products are safe for consumption. We've come to rely on this form of modern technology for the supply of all perishable goods--not just those that sustain us--but also those that make our lives better. So, if ever there was an area where precision is key, cold chain monitoring is it.

Cold Chain Monitoring

The Basics of Cold Chain Monitoring during Transport

ELPRO is synonymous with precision. We run our offices across the world like clockwork, so that our partners in the life sciences industries not only stay compliant, but they also deliver and thrive. In the following article, we will share some of our know-how on Cold Chain Monitoring in transit.

GDP Transport for Cold Chain Compliance

Good Distribution Practice (GDP) is a benchmark and a compliance requirement for the pharma industry, including manufacturers and their subcontractors. Good cold chain monitoring is a sure-fire way to ensure compliance.

To be compliant, conformity and integrity must be retained from the moment the product leaves the manufacturer and all through the supply chain, to the end customer. So, regular auditing isn't so much a nuisance as it is a necessity.

There are three key aspects to achieving cold chain compliance in transit: the equipment, the service, and transport conditions.

When it comes to the equipment used to secure and maintain temperature control, it must have GDP-compliant validation. This includes insulated packaging, refrigerated cabinets and cold rooms, as well as any devices used before shipping, in transit, or upon arrival.

A data logger is one such device, and the GxP compliant and calibrated LIBERO G is a fine example. This real-time temperature data logger and position tracker is FDA 21 CFR Part 11 compliant, with ISO 17025 calibrated sensors.

Likewise, operational teams must achieve the GxP qualification. Staff should be trained in temperature-sensitive product management, and the equipment they use should be designed specifically for temperature control.

Finally, transport conditions will impact compliance, so every shipment should come with a well-prepared route analysis. Seasonal variations are likely, and the best way to prevent mismanagement is to carry out trial shipments.

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Calibration Certificate for GDP-Compliant Cold Chain Data Loggers

What are the benefits of using a GDP compliant data logger? When it comes to the ISO 17025 accreditation, it's widely seen as a must-have for laboratories and research centers that perform tests and calibrate products.

Because this particular calibration certificate indicates compliance with not only technical and management requirements, it's a way for a laboratory to claim their technical expertise and competency.

Also, having this accreditation from the International Organization for Standardization, a revered regulatory body, is a means to certify that the results are accurate, consistent with industry standards and protocols, and unlikely to be disputed in court, business setting, or by a customer.

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Real-Time Monitoring for Transport: Avoiding Damage

Manufacturing and storing temperature-sensitive goods for optimum quality presents challenges, but transporting them across borders adds even more complexity.

Prone to damage not only at the lightest shock, but also due to variations in temperature and humidity levels, these goods can literally make or break a business.

This is where real-time cold chain monitoring comes in. Traditional GPS or GSM (2G/3G/4G), real-time measuring devices attach to the containers, taking round-the-clock readings and sharing them in real time.

The latest technology, ELPRO’s small and light LIBERO G family, uses 4G LTE mobile networks and new NB-IoT technology and offers valuable data that can be shared securely over an LPWAN (aka 'Mobile-IoT') network. Offering unfettered, low-power access for mobile and stationary applications with deep penetration within buildings, this tech is a game changer.

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Automated Control Systems for Cold Chain

Manual operations within cold chain monitoring pose a variety of challenges for forward-looking businesses. But the risks of human error, product and equipment damage, and high labor turnover are virtually none with an automated control system.

Rather than tweak the data to please a supervisor, ignore a deviation to finish the shift on time, or miss a discrepancy altogether, an automated control system will provide accurate, objective and precise readings.

Automated control is a way to prevent contamination and spoilage, reduce waste, save energy, time, and other resources. It can also increase shelf-life, secure infallible customer protection, and minimize insurance costs.

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With the LIBERO G range of data logger products, there is an added benefit of being able to choose the best device for a particular shipment. Whether it's meant to be used once, multiple times, or on an ongoing basis, the LIBERO logger is versatile for use in a variety of applications.

Also, there's a version best suited for storage monitoring. And the crown jewel of the LIBERO range is the GE model, ideal for ultra-low temperatures during cryo and dry ice shipments.

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Cold Chain Management with the Right Dashboard

Once you've secured the ideal logging device, one needs to consider the dashboard for analytics. Is it user-friendly, intuitive, and does it provide easy access at your fingertips? Because a badly designed dashboard can spoil the entire experience of real-time cold chain monitoring.

What users should be looking for in a data logging software package is just that: a package. The LIBERO Gx, for example, is an out-of-the-box solution. Simply turn it on, visualize a shipment's progress on a smartphone with the ELPRO website, and receive immediate notifications if something goes wrong.

But if one is partial to the idea of GxP compliant, secure, and live monitoring for not only shipments, but for equipment and rooms as well, there's a good case to be made for the ELPRO Cloud software package.

It lends itself for use with the LIBERO Gx unit, as well as the ECOLOG PRO range. Together with this professional grade software, these devices give you access to the live log, alarms, your stability budget, API integration, and an SaaS archive of your own.

LIBERO Cloud is the perfect solution to limitless, flexible, and unfettered access to a customizable database. Compatible with LIBERO Gx, Cx, and ITS models, it features all the capabilities of the ELPRO Cloud but with a few irresistible extras:

  • End-to-end monitoring for full and total control of how the data is displayed.

  • Multi-workflow for seamless transitions between data points.

  • Auto Assessment for round-the-clock assurance and reliability.

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Document Temperature Excursions and Set Up a Stability Budget

The stability budget is an essential aspect of cold chain monitoring. It is the result of the data from temperature studies and stability testing results. It determines the amount of time that a product can deviate from its labeled storage conditions.

From manufacturing, packaging and shipping, to when the customer uses it, the product's exposure is a journey through time that needs to be logged with precision, and temperature excursions must be taken into account every step of the way.

Rather than add up any reported deviations manually for each leg of the supply chain or distribute unused stability budgets for future legs, ELPRO prefers the "push forward" remaining stability budget (RSB) approach to cold chain management.

Being able to log these excursions will spare users the trouble of discarding perfectly good products, reduce logistics and packaging costs, optimize inventory, reduce waste and unnecessary documentation, and ultimately benefit customers.

With a stability budget such as this, users know for certain that the product is safe and that cold chain management duties were performed to the highest levels of transparency, without cutting corners.

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ELPRO's revolutionary suite of software and its range of high-precision LIBERO data loggers make it easy for customers to develop and keep track of Stability Budget.

With ELPRO, customers have a holistic, full-spectrum view of their operation. And this increased visibility into the inner workings of the business provides a competitive edge that will gradually nudge you higher in the sector, as LPWAN technology takes off.