What Serialisation Requires
Each saleable unit (carton, bottle, blister) must carry a unique 2D DataMatrix code containing: National Drug Code (NDC), serial number (unique per unit), lot/batch number, and expiry date. These codes must be printed, verified by vision camera, and uploaded to the national drug database before shipment.
The Aggregation Hierarchy
Serialisation typically operates at three levels: Item (individual carton) → Case (shipper box containing N cartons) → Pallet. Each level is aggregated — the case knows which items it contains, the pallet knows which cases it contains. This aggregation data enables track-and-trace at every level of the supply chain.
Vision System Integration
After printing, every code must be verified by a vision camera. Defective codes (unreadable, incorrect content, damaged label) must be rejected before packaging. The vision system must communicate pass/fail to the PLC within the machine cycle time — typically under 200ms. Failed units are automatically rejected and their serial numbers flagged in the database as unusable.
India SUGAM Requirements
India’s SUGAM portal requires batch-level upload for domestic market and item-level serialisation for export to regulated markets. Your serialisation system must generate the required XML/JSON upload files in SUGAM format and provide confirmation of successful upload before batch release.
Serialisation is a hardware + software + process project. The technology is well-established — the challenge is integrating it seamlessly into your existing packaging line without reducing throughput.
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