Frank Jäger, managing director at Faubel explores how the pharmaceutical industry can benefit from labels with RFID and e-paper technology.
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Smart labels speed up the supply chain
Over the centuries, the complexity of the supply chain for pharmaceuticals has grown steadily. In addition to conventional labels, the label specialist Faubel also produces labels with (radio-frequency identification) RFID and e-paper technology or enhances its labels with temperature sensors or tamper-evident features. “These smart labels can save time and money as well as lead to improvements," says Frank Jäger, managing director at Faubel. The accessible data flow provided by smart labels leads to greater transparency.
“The pharmaceutical industry already uses temperature sensors or RFID tags, but it is limited to certain applications which only take one part of the supply chain into account without being holistically structured”, explains Jäger.
Inventory management based on real-time data
Pharmacists and contract manufacturing organisations (CMOs) often operate a large number of production sites, depots and locations in different countries. Individual medicines or entire batches, or pallets of them, labelled with a smart label featuring RFID tags will feed data into inventory management platforms. Each RFID tag has a unique identification number. This UID (Unique Identification Number) can be located at any time, making it theoretically possible to trace the entire life cycle of a product.
In concrete terms, smart labels can be used in inventory management to keep a sensible balance between shortage and surplus. Inconsistencies, such as incorrectly placed products, can be promptly identified and appropriate action be taken to enhance picking efficiency. For quality management purposes, a comprehensive test documentation is available that has been stored on the platform in a summarised form. Thanks to their UID, smart labels also increase the level of security in the packaging of drug kits. Jäger is convinced of the benefits: “Inventory management based on real-time data can help to significantly reduce operating and administrative costs.”
Monitoring and protection
With smart labels, freight forwarders, wholesalers, clinics, pharmacies and even patients can take part in tracking and provide pharmacists with key data on the whereabouts of the medicines. RFID and NFC technologies – and the mobile and/or stationary readers that go with it – comply with standards.
“Investing in readers and IT infrastructure pays off quickly. Using NFC tags has another advantage: NFC-enabled smartphones can be used as readers,” adds Jäger.
Smart labels can improve brand protection because pharmacists or their supply chain managers are in a position to identify where a shipment went missing and see whether the drug or its packaging has been stolen. As highlighted by Jäger, “Weak links can be subsequently eliminated, the risk of product piracy will decrease." Smart labels are also used to prevent drugs from being removed from their original packaging and replaced by counterfeits. Like sealing labels, smart labels with NFC tags are applied across the opening area of the original packaging. Once the seal is broken, the NFC tag immediately registers that it has been tampering with and even patients are now able to figure out how intact the packaging of a drug is.
Automatic updating of IMPs
At the beginning of each clinical trial, the shelf life of investigational medicinal products (IMPs) is a factor which is difficult to quantify. During trials, new findings on the stability data of IMPs frequently emerge. If, for example, the shelf life of IMPs increases, this also impacts IMP labelling and therefore the entire supply chain. "Whenever stability data change, typically a re-labelling process is initiate where IMPs receive new labels that carry updated expiry dates," explains Jäger. Re-labelling takes time and can lead to delays in regular supply chains as well as to budget extension. IMPs may need to be shipped from the site to the depot where they are re-labelled before being returned to the site." The complete re-labelling process does not only mean time and cost, but compliance requirements for manual re-labelling are also high."
Since 2010, Faubel and Merck Sharp & Dohme have regularly exchanged ideas on how to completely replace re-labelling with smart labels when stability data change. An extensive benchmarking of possible technologies lead to the decision to focus on a combination of a label, an RFID tag and an e-paper display. "Fortunately, these smart labels have been marketable since spring 2017 after proving their worth in a variety of mock-up studies. It has been carrying the registered trademark of Faubel-Med Label since December 2014,” says Jäger. During the entire seven-year development phase, the whole challenge was about combining digital elements such as hardware and software with analogue components such as packaging in a way that is both user-friendly and operational for all stakeholders in the supply chain.
The Faubel-Med Label features a segmented bistable display which is able to show simple texts and numbers as well as 1D or 2D barcodes. This e-paper display is powered by electric induction without using any battery. In the Faubel-Med Label, the segment showing the stability data of the product can actually change. In other words, the expiry date of the product can be updated by receiving data from the RFID tag. All it takes is to place the product concerned on a reader. The Faubel-Med Label complies with Annex XIII guidelines. Beyond this, it allows expiry updates to be performed with a sealed kit that does not need opening, therefore supporting the implementation of Annex VI requirements. “This smart label brings about considerable savings to international clinical trials in terms of time and cost management. In addition, clinical trials can start earlier than in the past, and it is even possible to conduct trials involving limited stability data for the first time ever,” concludes Frank Jäger.