Serialization & Aggregation

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Serialization and aggregation processes stand as indispensable pillars within complete production lines for pharmaceutical packaging. Serialization encompasses the individual assignment of unique identifiers, such as serial numbers, 2D barcodes, or RFID tags, to each product unit. This ensures that every product can be distinguished and tracked independently throughout its lifecycle. Serialization is key to combat drug counterfeiting. Every drug that gets to the market receives a code to be identified.

Aggregation, on the other hand, involves grouping these uniquely identified units into larger hierarchical structures, such as bundles, cases, or pallets. Each aggregated level retains its own unique identifier, facilitating efficient tracking of products at various packaging levels. This hierarchical approach not only streamlines logistics but also aids in batch recall management and counterfeit detection.

Serialization in pharmaceutical packaging is required as follows:

• Primary packaging: Not required (sachets are not sold individually) in any market other than the American and Indian markets.
  
• Secondary packaging: Compulsory (cartons are sold individually). Some regulations, such as EU-FMD, require Tamper Evident, along with pharma serialization, to guarantee that the medicine is first opened by the patient.
  
• Tertiary packaging (aggregation): Compulsory and fundamental to ensure traceability.
  

Serialization and aggregation processes on Universal Pack lines comply with regulatory requirements set forth by authorities such as the FDA (Food and Drug Administration) in the United States and the EMA (European Medicines Agency) in Europe. These regulations mandate the implementation of robust serialization and aggregation systems to combat counterfeit drugs, prevent product diversion, and safeguard patient safety.

Integrating serialization and aggregation into packaging lines ensures seamless tracking and identification of pharmaceutical products across the supply chain. This not only enhances transparency and accountability but also bolsters consumer confidence in the integrity and authenticity of the medications they rely on.