Cold chain logistics makes the world go 'round with the help of cold chain monitoring to prove products are safe for consumption. We have 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. Therefore, if ever there was an area where precision is key, cold chain monitoring is it.
01 An Introduction to Cold Chain Monitoring
To become an expert on cold chain monitoring, you must begin by understanding who is involved, what technologies are available, the process, and the science of degrading perishable products. The cold chain has evolved in recent times mainly due to the growing market of biological products in the pharmaceutical industry.
02 Stability Budget Explained
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 recommended or labeled storage conditions.
03 GDP 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, products must retain conformity and integrity from the moment the product leaves the manufacturer and all through the supply chain, to the end customer. Therefore, regular auditing 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. The 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 GxP qualification. Training on temperature-sensitive product management is essential, and they should use equipment designed specifically for temperature control.
Finally, transportation conditions can interfere with 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.
04 Documenting Temperature Excursions
From manufacturing, packaging and shipping, to consumption, the product's exposure is a journey through time that needs to be monitored 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. Data loggers track the budget along the entire life cycle and subtract used budget throughout the way.
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 can be confident the product is safe, and that cold chain management duties were performed to the highest levels of transparency, without cutting corners.
ELPRO's revolutionary suite of software and family of high-precision LIBERO data loggers make it easy for customers to configure and monitor the stability budget.
With ELPRO, customers have a holistic, full-spectrum view of their temperature-controlled shipments. This end-to-end visibility provides a competitive edge that will prepare an organization well for the time when LPWAN technology becomes more widely utilized.
Documenting Temperature Excursions
It is crucial having the right tools in place to easily document your temperature excursions,
05 Automated Control Systems for Cold Chain
Manual operations within cold chain monitoring pose a variety of challenges for forward-looking businesses. However, the well-documented risks of human error, product and equipment damage, and high labor turnover are virtually eliminated 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 provides 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 and minimize insurance costs.
ELPRO LIBERO G real-time data loggers provide this capability in a way that is scalable to fit your needs. Whether it's meant to be used once or multiple times, there's a version best-suited for your operations. The crown jewel of the LIBERO family is the GE model, ideal for monitoring ultra-low temperatures, LN2 cryogenic, and dry ice shipments.
Automated Control Systems in a Cold Supply Chain
Machines learning algorithms and metadata logging can help develop better long-term strategies, benchmarks, and targets in your cold chain.
06 Real-Time Cold Chain Monitoring
Manufacturing and storing temperature-sensitive goods for optimum quality presents challenges, and transporting them across geographic borders adds even more complexity.
Many pharmaceuticals are prone to damage during shipment, and are highly sensitive to fluctuations in temperature, relative humidity, tilt, shock, light, and more. Damage occurring during shipment can result in millions of dollars in lost medication. Not to mention the shipment not arriving safely to meet the needs of the patients.
Under these highly-sensitive conditions is where real-time cold chain monitoring capabilities shine. 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 delivers valuable data that is shared securely over an LPWAN (Mobile-IoT) network. The solution offers unfettered, low-power access for mobile and stationary applications and deep penetration within buildings. This tech is a game changer.
Real-Time Cold Chain Monitoring
Improve technology on your cold chain processes. You can improve efficiency and reduce costs.
07 Cold Chain Management—Get everything under control with the right software
Once you have secured the appropriate data logging device, you need to consider the software you will use for analytics. Is it user-friendly, intuitive, and does it provide easy access to your data at your fingertips? A badly designed dashboard can spoil the entire concept 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 data logging solution. Simply turn it on, track a shipment's progress and stability budget on a smartphone or any web browser, and receive immediate notifications if something goes wrong.
Both ELPRO Cloud and LIBERO Cloud are software packages that can be utilized with LIBERO Gx real-time data loggers. They provide superior dashboard analytics and can be integrated into any third party software (e.g., ERP) through an API integration.
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
- Automatic assessment for round-the-clock assurance and reliability
Cold Chain Management—Get everything under control with the right software.
You need a compliant program that is easy-to-use.
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