Digital Labels on Printed Pharma Foil Revolutionized Products
Labeling is an essential component of the supply chain. This is especially true for investigational medical products (IMPs), which must bear unambiguous expiration dates and other required information. However, IMP shelf life is notoriously difficult to calculate, and new data on their stability emerge frequently throughout clinical trials. This frequently necessitates companies relabeling IMPs with altered expiry dates and Pharma Foil other information. It’s an expensive and time-consuming operation that has ramifications throughout the supply chain.
Smart Label Impact on Pharma Foil Packaging
While smart labels with radio frequency identification (RFID) tags have grown commonplace in pharmaceutical manufacturing, IMP labels used in clinical trials have not been as easily adopted. However, as clinical trials get more complex and expensive, finding strategies to make IMP materials more efficient and cost-effective is critical. Paper IMP labels, for example, must incorporate a number of regulatory requirements. To achieve these standards and fit the information onto the limited space available (say, on a syringe or vial), providers are frequently obliged to use very small, practically incomprehensible letter sizes. When expiry data changes, which is especially common with biopharmaceuticals, each package must be manually relabeled, which is a costly and time-consuming process.
However, digital technology is assisting clinical trials in finding new ways to incorporate speedier and lower-cost labeling solutions for IMPs. Electronic labels (e-labels) can include a regulatory-compliant IMP label and may reduce or eliminate deviations caused by extended relabeling, sterility breaches, tamper-evident seal removal, product mix-up, and temperature excursions. Furthermore, IMP modifications affecting label content can be conveyed rapidly.
Evaluation of Smart Labeling
Despite appearances, the first e-label was patented in 1952. While it was functional, it was too expensive for large-scale implementation for more than 20 years. In 1973, IBM adopted the concept, resulting in the ubiquitous one-dimensional bar code known as the Universal product code. By 1980, 8,000 retailers per year were using symbols and scanning systems. Since their introduction in supermarkets, bar codes have found a wide variety of applications in the pharmaceutical business, including drug manufacture, security, identification, traceability, and expiry information.
In 1990, two-dimensional (2D) bar codes were introduced. These graphics, which contain far more information than their one-dimensional forefathers, may be read both vertically and horizontally. As part of worldwide serialization programs and other health authority guidelines, they are utilized on main and secondary pharmaceutical packaging. 2D data matrix codes, for example, have been part of European pharmaceutical regulatory obligations since January 2011.
Benefits of Using Smart Labeling with Pharma Foil Packaging
Regulatory Compliance
Neither the EU rules nor Section 21 of the United States Code of Federal Regulations requires labels to be manufactured entirely of analog materials such as paper. RFID technology is not prohibited on labels, and individual components such as antennas or sensors are not covered by these guidelines. “Previously, authorities had no issue with inventive labeling as long as content, durability, and legibility standards were met,” Barone explained. “A smart label with an RFID tag, an e-paper display, and a booklet label fully conforms with Annex XIII,” he stated. The pharmaceutical industry may have difficulties in implementing Annex VI.
Temperature
Temperature changes of 2°-8°C, as well as high temperature and humidity levels in the supply chain, might cause quality issues for many cold-chain IMPs. Smart labels with RFID temperature sensors can resist extreme temperatures. The updated device is temperature rated to -5°C, while the e-paper display is temperature rated to -20°C. Depending on the needs, booklet labels can be created of temperature and moisture-resistant paper, pharma foil, adhesives, and inks.
Pharmaceutical Product Tracking
Because the program retains the UID of each RFID tag, the software can update numerous expiry dates and counters within the kit in a single transaction. Data on individual shipments are obtained in real-time as soon as the tag begins exchanging data with the upgraded device. Before being combined into batch documents, data for each labeled Pharma Foil or medical packaging is automatically kept in the software.
When logistical product flows must be controlled and monitored, this might serve as a source of information for inventory management. If an allocation issue happens, for example, when the container is dispatched from the depot, it can be detected if data transfer is performed with an updated device. Pharmaceutical product boxes that have been incorrectly addressed can then be removed from transport.
Final Words
Smart labels on pharmaceutical products are highly in demand due to their various benefits. Custom Printed Boxes with these smart labels are easier to manage. They’re helpful to manage inventory or keep tracking the record of products automatically.