New fail-safe technology is enabling pharmaceutical companies to monitor and log ambient, cold and freezing conditions of products, from the point of manufacture to the patient’s refrigerator, simply by attaching and breaking the indicator’s start tab.
Distributed by local technology integrator, Euca Technologies, the Libero ITS indicator is a small device that monitors the temperature stability and shelf-life of a product during the end-to-end journey. Indicator Tab Start (ITS) technology means that it is simply started by breaking a tab. Whereas traditional data loggers are bulky, the Libero ITS is thin and durable to attach at unit-level or on a clinical kit to patient administration.
Euca Technologies Managing Director, Ernest Campling, says one pharmaceutical shipment may pass through various countries with different temperature conditions, get handed off at multiple depots, then transferred to the next supply chain partner, wholesaler or pharmacy. That is where the value of the Libero ITS comes to the fore, as it is smart enough to record deviations, create reports and manage individual stability budgets.
“The free Smartphone app is a great convenience tool for any receiving site, clinic, or pharmacist. It provides a one-touch stability budget read-out, showing percentage of budget used; which alleviates the need to piece together different “Time out of Refrigeration (TOR)” segments. The LIBERO ITS Smartphone app also allows the user to easily print or email the PDF report from the app to communicate the release or status of the monitored product.
“The PDF can be archived in a cloud database, liberoMANAGER and still catalogue the valuable data to support logistics trending. Manufactured by global monitoring company, ELPRO, the sensors are fully “Good Distribution and Storage Practice (GxP)” compliant, having gone through rigorous US and international validation, ensuring FDA CFR 21 Part 11 and each device comes with a NIST traceable calibration certificate,” adds Ernest.
- Pre-configured with specific product stability budget to expedite sending site packaging processes
- Enables end-to-end unbroken temperature monitoring, by using one device on box-level to monitor the entire chain
- Constantly calculates and shows the remaining stability budget, for an immediate go/no go product release decision at any time
- 4-year battery life
- 3mm thick, 30x30mm in size, making this very small device easy to stick-on (with self-adhesive tape) to any unit-level package
- Status and statistics can be downloaded and documented wirelessly via Libero ITS Smartphone app
- Data can be archived in liberoMANAGER and used for trending and dashboards
Ernest says that so far, the first customer reviews of the new ITS call it a ‘game changer’ for its ability to offer one validated device to measure temperature for up to 4 years in a long, fragmented supply chain. The affordability, size and smart capabilities of this long-term indicator at unit-level offer exciting possibilities to improve patient outcomes, reduction of product waste, and on-time safe clinical trials. Using a smartphone app, the stability budget can be read at point of use.
“The LIBERO ITS offers end-to-end assurance for increasingly complex global supply chains, with several transit and storage points, and various handlers. It provides unbroken monitoring from point of manufacture, to time of use. It is also one of the most cost-effective, long-term solutions on the market.
“At the recent IQPC Cold Chain Global Forum, Libero ITS was awarded the 2018 Excellence Award in the category of “Best Global Temperature Control,” he concludes.
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