The Regulatory Landscape Has Changed
Over the past decade, serialisation requirements have moved from a future regulatory aspiration to a present operational reality for pharmaceutical manufacturers in most major markets. The EU Falsified Medicines Directive, the US Drug Supply Chain Security Act, China’s NMPA serialisation requirements, and equivalent regulations in dozens of other markets all mandate that individual medicine packs carry unique identifiers — typically 2D barcodes — that allow the product to be tracked from manufacture to dispensing.
For cartoning machine operations in the pharmaceutical sector, integrating serialisation into the cartoning process is no longer optional. Understanding what this integration involves and how to implement it effectively is essential knowledge for any pharmaceutical packaging operation.
What Serialisation Requires at the Carton Level
A serialised carton must carry a unique identifier — typically a GS1 DataMatrix 2D barcode — that encodes the product GTIN, the serial number, the batch/lot number, and the expiry date. This code must be applied to each carton individually, verified immediately after application to confirm it is readable and meets quality standards, and the data must be reported to a national medicines verification system.
All of this must happen at the speed of the cartoning machine production line — which may be producing several hundred cartons per minute — without reducing throughput or introducing a new source of defective product.
Print and Verify Integration
The most common approach to serialisation integration on a cartoning machine is a print-and-verify station integrated into the carton flow immediately after carton erection or before end flap closure. An inkjet or laser coding unit prints the unique 2D barcode onto each carton. A vision camera immediately reads and verifies the printed code — confirming that it is present, correctly positioned, and meets the minimum print quality standard for reliable reading throughout the supply chain.
Cartons with missing, unreadable, or incorrectly printed codes are rejected automatically before they proceed to loading and sealing. The reject mechanism must be reliable and clearly visible, with rejected cartons going to a secure collection point rather than being capable of re-entering the line.
Aggregation: The Additional Complexity
Beyond individual carton serialisation, many supply chain track-and-trace requirements include aggregation — the association of carton-level serial numbers with the cases and pallets that contain them, creating a complete hierarchical record of which individual packs are in which case and which cases are on which pallet.
Aggregation at the cartoning machine level involves additional scanning stations that read carton codes as they are packed into cases, and software that builds and reports the aggregation hierarchy. The complexity of implementing aggregation correctly — and maintaining data integrity through the inevitable line stoppages, rejects, and manual interventions that occur in real production — is considerably greater than carton-level serialisation alone.
Choosing a Serialisation Partner
Serialisation integration on a cartoning machine is typically a joint project between the machine manufacturer, a serialisation software partner, and the pharmaceutical manufacturer’s IT and operations teams. Choosing partners with proven track records of successful serialisation projects — in the specific regulatory markets that apply and at comparable production speeds — significantly reduces the risk of a difficult and costly implementation.
The serialisation landscape continues to evolve as regulations are refined and extended to new markets. Choosing a software platform that is actively maintained and updated to reflect regulatory changes protects the investment in serialisation infrastructure against the need for costly remediation when requirements change.