In highly regulated sectors like pharmaceuticals and medical devices, labelling is far more than a branding or informational tool — it is a vital component in product identification, patient safety, regulatory compliance, and traceability. As these industries continue to grow in complexity and volume, the need for reliable, high-speed automatic labelling systems has never been more important.
Every pharmaceutical product and medical device must carry a label that precisely identifies what it is, who manufactured it, and key information such as dosage, usage instructions, and warnings. Beyond that, labels serve as an essential means of authentication, helping prevent counterfeiting and ensuring product integrity throughout the supply chain.
With patient safety on the line, accuracy and reliability in labelling are non-negotiable. An incorrectly labelled vial or misprinted device package could have life-threatening consequences, leading to product recalls, legal liability, and reputational damage.
Pharmaceutical and medical device labels must often include variable data, such as:
Batch or lot numbers
Expiry dates
Unique serial numbers
GS1-compliant barcodes or 2D codes
This information is critical for product traceability — enabling manufacturers, regulators, and healthcare providers to track products through the supply chain, manage recalls, and comply with regulations such as the EU Falsified Medicines Directive (FMD) and U.S. FDA’s Unique Device Identification (UDI) requirements.
To meet these stringent requirements, automatic labelling machines are designed not just to apply labels at high speeds, but also to print, verify, and reject labels and products that do not conform.
Integrated vision systems play a crucial role in this process, instantly verifying that variable data is printed correctly and legibly. If a barcode is unreadable or a date is missing, the system can automatically reject the label or the product before it leaves the line — reducing errors and ensuring compliance.
There are multiple technologies available to handle variable data printing, each suited to different production needs.
Thermal transfer coders (TTC) are commonly integrated into labelling systems to print variable information over pre-printed labels. They offer:
High-resolution, durable prints
Excellent control over small print areas
Cost-effective operation for products with consistent base label designs
TTCs are ideal when only a section of the label — such as the batch code and expiry date — requires updating for each run.
Print & apply labellers, on the other hand, print the entire label on-demand and immediately apply it to the product. These systems are especially useful when:
Large areas or the full label need to be customized
Products require frequent label changes (e.g., different languages, dosage forms, or customers)
Variable data must be prominently and flexibly presented
They offer a higher degree of adaptability but may involve greater material costs and slightly slower throughput depending on the application.
When selecting an automatic labelling system for pharmaceutical or medical device production, manufacturers must consider:
Required print area and type of variable data
Speed and volume of production
Regulatory requirements
The importance of in-line verification and rejection systems
Integration with existing MES or ERP systems for seamless data flow and traceability
At Advanced Labelling Systems Ltd, we specialise in high-performance custom labelling solutions, tailored to the rigorous demands of the pharmaceutical and medical device industries. Whether you need a compact thermal transfer labeller for a blister pack line or a robust print & apply system for serialised cartons, our machines are built for accuracy, reliability, and compliance.
Contact us today to learn how we can help ensure your products are labelled with precision, verified with confidence, and delivered with compliance.