Serialisation and aggregation line commissioned

The new line applies a unique identifier to each saleable pack in a GS1 DataMatrix (ECC200) carrying the product GTIN, expiry date, batch or lot number and a unique serial number, encoded under GS1 Application Identifiers (01), (17), (10) and (21) respectively. Immediately after printing, an in-line vision station reads and grades every code, confirming both the encoded data and print quality so that unreadable or malformed marks are rejected before the pack proceeds. Only packs that pass verification continue to secondary packaging.

“Every saleable pack now leaves the line with a verified unique identifier, and every case and pallet is aggregated to its contents, so a consignment can be authenticated without being opened.”

At the end of the line, aggregation links each serialised pack to its case, and each case to its pallet, with the SSCC (00) applied at case and pallet level. These parent-child relationships are captured as EPCIS events, producing an auditable hierarchy that lets a full case or pallet be received, verified or decommissioned by reading a single outer code rather than opening the container. This is the practical foundation for consignment-level track-and-trace across the distribution chain.

For distributors, Ergopharm export packs now carry the data structures expected by the serialisation and verification regimes operating in major markets, including the unique-identifier and aggregation approaches that underpin frameworks such as the EU Falsified Medicines Directive and the US Drug Supply Chain Security Act. Aggregation also reduces goods-in handling: cases can be reconciled against their contents without unpacking, and any future returns or recalls can be actioned precisely at the level of the affected batch or pack.

For patients and dispensers, a verifiable unique identifier on each prescription-only pack is a direct safeguard against diversion and falsification, allowing authenticity to be confirmed at the point of dispense where local systems require it. The line integrates with Ergopharm's existing GMP packaging controls and Batch Manufacturing Record, so serialisation and aggregation data are generated and retained as part of the batch record rather than as a separate step.