Vision-system code grading added

Serialisation only protects the supply chain if the printed code can actually be read, every time, by every downstream scanner. To assure this, each carton now passes a camera station immediately after printing. The vision system decodes the GS1 DataMatrix (ECC200), confirms that the encoded Application Identifiers — GTIN (01), expiry (17), batch (10) and serial (21) — match the values expected for the batch, and assigns an ISO print-quality grade to the symbol.

“A serial is only useful if it scans first time, everywhere — grading each code in line is how we make sure it does.”

Any carton whose code is unreadable, mis-encoded or below the minimum grade is rejected and reconciled, so it cannot enter the released count. Because the check happens in line with printing and aggregation, a failed code is caught at the pack rather than discovered later at a distributor's goods-in. The result is a measurable reduction in the risk of a 'dead' pack — one that is serialised on paper but cannot be verified in practice.

The grading step is documented within the Batch Manufacturing Record and forms part of the in-process controls for the packing operation, consistent with the company's ICH Q10 pharmaceutical quality system and its data-integrity expectations. Reject and reconciliation data are retained with the batch, giving a complete account of how many codes were printed, passed, rejected and aggregated.