Serialization is an increasingly important way to protect patient safety and ensure product integrity by minimizing the risk of counterfeiting.
Because serialization regulations will vary from country to country, pharmaceutical companies face unprecedented complexity, cost, and risk in how they implement strategies in different parts of the world.
- Patient Safety
- Inventory Management and Returns Processing
- Efficient Product Recall
- Regulatory Requirements
Why Catalent for Serialization
- Catalent has experience in serialized production for US, EU, China, and South Korea markets.
- Across 10 sites equipped for serialization, Catalent can offer customized packaging and serialization solutions covering all 4 levels of aggregation, including very small batches using an offline approach.
With Catalent’s thorough understanding of serialization requirements, we can support product introductions to new markets which require serialization, as well as currently marketed products that must comply with new regulations.
How serialization works
Global serialization requirements across each Catalent site are typically grouped into the following categories: Line Level Equipment, number range management, and Serialized Warehouse Console.
- Line Level Equipment: The equipment and software will print and verify serialization data on inner cartons, cases, bundles (when necessary), and pallets.
- Number Range Management (NRM): This cloud based application will import serial numbers from the customer or internally create randomized serial numbers for each item number
The serial numbers and serial shipping code numbers are pulled from the NRM to the Line Level Equipment for printing and aggregation. At the end of each batch, the Line Level Equipment transmits the events, aggregation, and the associated serial numbers of that batch back to the NRM repository. An EPCIS report with the aggregation events will be sent to the customer when the product is shipped from a Catalent packaging site. EPCIS file containing the following:
- Serialized Warehouse Console (SWC): When material handling takes place post manufacturing, the SWC provides a product handling solution that captures and processes data within the Catalent supply chain. The solution is served by a class of business systems known as edge-of-network (EDGE). The SWC uses bar code scanning technology to communicate with NRM and Catalent’s ERP (Enterprise Resource Planning) system. This technology minimizes the potential for transcription errors and interface challenges with NRM and ERP. The SWC is typically used for serialized product sampling, rework, product lookup, shipping and returns
Catalent’s serialization capability
Packaging – Breadth of Modern Equipment
A global footprint of Primary, Secondary and Tertiary Packaging capability across all technologies and dosage forms (solid and liquid).
- 30+ sites, 10 equipped for Serialization, with the possibility to adapt standard lines for more flexibility
- Technical expertise across multiple packaging formats
- Fully automated bottling lines including automatic cartoning and case packing.
- Stick Pack filling with fully integrated cartoning systems.
- Form fill/seal blister lines with integrated cartoning and collation.
- Pouch filling and automatic cartoning.
- Syringe Filling, Labelling and blister packaging.
- Blow/Fill Sealing, Leak detection, Labelling and cartooning.
- Ampoule and Vial Filling.
- Customized packaging concepts
Serialization Implementation Methodology
- Governance document for standard implementation
- Processes in place to on-board customers quickly
- Internally generated serial numbers
- Standard label format and printing parameters
- Standard EPCIS reports following GS1 standards
- Flexible to customer needs
- Leadership oversight on customer projects
- Developed stage gate approach for Serialization
- Dedicated team for every customer
- Global oversight ensuring standardized implementation for all sites