Overview
A leading pharmaceutical company required immediate compliance with Korean serialization regulations, mandating SGTINs on secondary packaging and Human Readable Text (HRT) to GS1 standards. Non-compliance risked penalties, restricted market access, and operational disruptions.
Additionally, the company needed an off-line warehouse solution to commission and decommission products out of batch, ensuring accurate product status updates, traceability, and regulatory adherence without disrupting operations.
Catalyx implemented a comprehensive Track & Trace solution, integrating hardware, software, and advanced vision technology to deliver seamless compliance, enhanced traceability, and operational efficiency.
Challenges
Ensuring Compliance with Strict Korean Serialization Regulations
The project required immediate compliance with Korean market regulations, mandating pharmaceutical product serialization on secondary packaging. Each package needed a unique item-level serial number (SGTIN) in 2D barcode or RFID format, along with five lines of Human Readable Text (HRT) for lot codes, expiry dates, pricing, and other variable data, all adhering to GS1 standards. Non-compliance could result in regulatory penalties, market access restrictions, and operational disruptions.
Critical Requirement for Off-Line Warehouse Commissioning & Decommissioning
Beyond serialization, the customer urgently required an off-line warehouse solution to commission and decommission products out of batch. This complex workflow challenge demanded a robust system to efficiently manage product status changes while maintaining strict traceability and regulatory compliance to avoid disruptions in operations.
Our Solution
The Catalyx team of Software and Installation & Commissioning Engineers developed a comprehensive solution integrating Catalyx hardware and software, the Track and Trace Solution System, and Cognex Cameras to ensure seamless performance and compliance.
Step 1: Upgraded the Camera System
To eliminate rejected serialized codes, the team implemented an innovative three-camera system, upgrading the standard two-camera setup. This enhancement significantly improved verification accuracy, reduced false rejections, and ensured compliance with serialization requirements.
Step 2: Software Integration
The software solution was designed with a multi-tiered architecture to ensure precise tracking and real-time data flow. It included the transmission of serial number to the line control system, which in turn interfaces with the site database. Additionally, full integration with the client’s MES and ERP systems was achieved by linking GTS with MES and ERP, enabling efficient serialization management, end-to-end traceability, and regulatory compliance
Step 3: Integration of a Hand-Held Scanner
To meet the customer’s requirement for an off-line warehouse solution, a hand-held scanner was integrated into the manual station, enabling seamless product commissioning and decommissioning outside of batch production. This solution allows for efficient code reading, real-time status updates, and quality control sampling, ensuring full traceability, compliance, and operational flexibility.
Outcomes
Seamless Compliance & On-Schedule Implementation
Successfully achieved full compliance with Korean market serialization regulations by implementing a robust, validated serialization system. The solution was installed, tested, and fully operational on schedule, ensuring regulatory adherence, product traceability, and seamless market entry.
Enhanced Warehouse Efficiency & Compliance
The integration of a hand-held scanner into the manual station enabled seamless commissioning and decommissioning, improving operational efficiency and traceability. This solution ensured real-time status updates, accurate code reading, and efficient quality control sampling, allowing the client to maintain full regulatory compliance while optimizing warehouse flexibility.
Conclusion
By implementing Catalyx’s integrated serialization and warehouse solution, the client successfully met all Korean market compliance requirements while optimizing their production and warehouse operations.
A three-camera system upgrade improved verification accuracy, reducing false rejections and ensuring flawless serialization. Multi-tiered software integration enabled real-time tracking and seamless data flow across MES, ERP, and global tracking systems. Additionally, a hand-held scanner for off-line warehouse operations streamlined product commissioning and decommissioning, improving efficiency, traceability, and quality control.
With full regulatory compliance achieved on schedule, the client now benefits from enhanced serialization management, warehouse flexibility, and a future-proof solution for continued market success.