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Electronic Position Indicators Ensure Process Security in Track-and-Trace Systems

Compliance with the EU FMD requires implementation of traceability systems. The TQS (Traceable Quality System) from WIPOTEC-OCS employs a position indicator from SIKO GmbH that offers process security during format changes.

TQS serial numbering system with classical mechanical position indicators from SIKO (Image: © WIPOTEC-OCS)
TQS serial numbering system with classical mechanical position indicators from SIKO (Image: © WIPOTEC-OCS)

The recently enacted European Union Falsified Medicines Directive (EU FMD) aims to protect consumers against falsified medicinal products by requiring all prescription medicines to be clearly labeled in a way that allows the entire production and transport process to be traced. These serial numbers are registered with a central European database and verified at the pharmacy level by scanning a data matrix code before they are given to patients.

Though the pharmaceutical industry was aware of the directive’s Feb. 9, 2019 deadline for three years, there was a fervent increase in demand for track-and-trace systems in the months leading up to the enforcement date.

WIPOTEC-OCS, which specializes in weighing and inspection systems for processes such as printing, reading and labeling, confirms this trend. "This is a massive drag on the market now. As of February, every company that produces prescription medication and wants to bring it on the market needs to ensure that serial numbers are assigned to the medication and that they have integrated a track-and-trace solution in their production line," explains Daniel Anders, Product Manager for Track & Trace at WIPOTECS-OCS.

Traceable Quality System

Pharmaceutical manufacturers seek systems that can be integrated into the production line quickly and without major expenses. Another key consideration is that the systems do not slow down the production process unnecessarily, which would have a severe negative impact on production efficiency.

With its TQS (Traceable Quality System), WIPOTECS-OCS offers modular labeling of pharmaceutical products according to all country-specific requirements.

The TQS-HC-A machine combines serial numbering steps including printing, reading, labeling and weighing into one unit. It is designed for folding boxes, which make up at least 90% of medication packaging in the European market.

Boxes are labeled on the front and/or back—optionally on the top as well—and are then weighed with a high-precision load cell to detect whether the boxes are fully packed. Faulty products are automatically sorted out. Where needed, tamper-evident labels can be applied to secure the packaging against manipulation.

For pharmaceutical manufacturers who often have long production lines, it is important to have a compact track-and-trace system. With the new FMD requiring manufacturers to commit large initial investments and resources, Anders says, "We don't want complicated systems that provide additional impediments to processes. Acceptance by the pharmaceutical industry is much higher if track-and-trace machines can fit smoothly into the overall concept."

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LAST CHANCE TO SAVE! New Tech for Life Sciences at PACK EXPO Southeast