LIBERO ITS - a 'game changer' in temperature monitoring
24 Sep 2018
Throughout a long and complex supply chain of a medicine from manufacturing to patient, there are many risks.
One pharmaceutical shipment may pass through various countries with different ambient conditions, handed off at multiple depots, then transferred to the next supply chain partner, wholesaler or pharmacy. How does the end-user know if there have been any temperature deviations and for how long? How does the end-user know if it’s safe to consume?
The LIBERO ITS is one small device that monitors temperature end-to-end. The new solution is called LIBERO ITS (Indicator Tab Start) because it’s simply started by breaking a tab. Whereas traditional data loggers are bulky, the LIBERO ITS is thin and durable to attach at unit-level; making it all the way from point of manufacture to a patient’s refrigerator, or on a clinical kit to patient administration. End-to-end product quality assurance like you’ve never seen before.
At the same time, LIBERO ITS is still 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 one-touch stability budget read-out showing percentage of budget used; alleviating piecing 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 app to communicate the release or status of product. Even more, the PDF can be archived in a cloud database, liberoMANAGER, still cataloguing the valuable data to support logistics trending.
Like any ELPRO product, the LIBERO ITS is fully GxP compliant, having gone through rigorous GAMP5 validation, ensuring FDA CFR 21 Part 11 and each device comes with a NIST traceable calibration certificate.
Highlights of LIBERO ITS include:
- 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
- Priced for the box level: <$3 for larger quantities
- 4 year battery life
- <3mm thick, <30x30mm in size, making this very small device easy to add by self-adhesive to any unit-level package
- Status and statistics can be downloaded and documented wireless by LIBERO ITS Smartphone app
- Data can be archived in liberoMANAGER and used for trending and dashboards
First customer reviews of the new ITS call it a ‘game changer’ to temperature monitoring in the life science supply chain. The size, the price, clear-cut decision making at point-of-use – make this new device highly valuable in many life science and healthcare applications such as Direct-to-Patient clinical trials, hospital blood shipments, and finished product last miles.
Simon Kaufmann, Product Development Manager at ELPRO describes the need for this type of advanced indicator; “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. At $3 a device, with 4-year battery, this solution solves many problems being of the most cost-effective, long-term solutions on the market”.
ELPRO will be market launching the LIBERO ITS at the IQPC Cold Chain Global Forum in Philadelphia September 24th week. Visit the ELPRO booth. Or attend the ELPRO workshop on “Stability Monitoring & Technology Innovation in the Temperature Controlled Life Science Supply Chain”.