Serialization

Serialization means that every individual sales unit of a product receives a unique serial number – machine-readable (e.g., as a DataMatrix code) and digitally registered in IT systems. The goal is the globally unique identification of every single unit.

Serialization is most common in pharma, MedTech, and medical devices, and increasingly in agrochemicals and cosmetics. In these industries, it is not optional – it is a regulatory requirement.

Why Serialization?

Three drivers define the requirement:

Anti-counterfeiting and patient safety: Fake or tampered products must not enter the legal supply chain. A unique, verifiable serial number makes counterfeits detectable.

Targeted recalls: When quality issues arise, exactly the affected serial numbers can be quarantined – without blocking entire batches or country markets.

Regulatory requirements: Laws in many markets require serialization and verification for prescription pharmaceuticals.

Packaging Hierarchy and Aggregation

Serialization operates across multiple packaging levels: individual pack, bundle, shipping carton, pallet. Each level receives its own identifier, linked to subordinate levels through aggregation.

The result: a single scan at pallet or carton level is enough to identify all contained serial numbers – without scanning each pack individually. This is critical for efficiency in logistics and warehousing.

Serialization, Track & Trace, and Product Genealogy

Serialization is the foundation for broader supply chain transparency:

Track & trace follows where a unit has been along the supply chain – from production to pharmacy or end customer.

E2E traceability and product genealogy link the serial number to batch, production data, inspection results, lines, and shifts. This linkage transforms a bare ID into a complete digital product history.

Role of MES, ERP, and Line IT

Effective serialization requires coordination across multiple layers:

Line and packaging control: Printers, labelers, and vision systems generate, print, and verify codes; aggregation is built at the line level.

MES: Links serial numbers to orders, batches, product variants, and lines. Tracks valid and quarantined serials and provides data for genealogy and quality analysis.

ERP: Processes serial data during goods issue, distribution, and returns.

External repositories: In regulated markets, serial numbers must be reported to national databases and verified at the point of dispensing.

Without clean integration, serialization remains an isolated system on the packaging line. Only with MES and ERP connectivity does it become a strategic pillar of compliance and supply chain transparency.

FAQ

What is the difference between serialization and batch traceability? Batch traceability tracks groups of units (batches, lots). Serialization goes one level deeper: every individual sales unit has its own unique ID – independent of the batch.

Is serialization only relevant in pharma? Pharma and MedTech are the primary adopters, but agrochemicals, cosmetics, and high-value consumer goods are increasingly implementing serialization – driven by regulation and anti-counterfeiting requirements.

What happens if a serial number is assigned twice? A duplicate serial number is a critical error: it undermines the entire traceability chain and can have regulatory consequences. Modern serialization systems prevent duplicates through centralized ID management and real-time validation.