Case study: Advanced Serialization Solutions in the USA

This case study highlights the successful partnership between a leading pharmaceutical company in the United States and SEA Vision USA. This collaboration resulted in significant improvements in operational efficiency and regulatory compliance. 

Highlight 

This solution combines advanced Track & Trace technology with our most powerful OEE tool within the L3 system. Thanks to deep integration with machine PLCs, it collects comprehensive data from the equipment – including counters, reports, alarms, audit trails, and more.

Operational Simplicity with Yudoo
Yudoo enables operators to start the entire batch directly from a single HMI, selecting all necessary equipment formats for a specific SKU with just one click. This streamlined process eliminates human error and saves time in batch setup.

Real-Time Performance Insights with Yuview
The customer is actively using SEA Vision’s newest module, Yuview, for real-time data analysis and OEE calculation on each machine in the line. This ensures constant performance feedback to drive production improvements. Additionally, Yuview automatically collects and displays data on machine status, production counters, downtime causes, and alarms, providing a clear and immediate overview of line performance.

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Challenges 

A leading pharmaceutical company in the USA needed to enhance product traceability and meet strict regulatory requirements. They face several challenges, including: 

• Regulatory Compliance: Navigating stringent international regulations for packaging and serialization. 

• Traceability: Achieving comprehensive product traceability from production to end consumers. 

• Operational Efficiency: Real-time monitoring to identify and eliminate inefficiencies in the production line. 

SEA Vision’s Comprehensive Solution

To address these challenges, SEA Vision implemented a tailored solution that involved advanced vision systems and serialization technology. The integration involved four key machines in the production line, each enhanced with SEA Vision’s innovative technology. 

1. Labeling Machine 

• Function: Applies labels to glass bottles. 

• Technology: Utilizes a vision system to check codes and characters on labels, discarding defective labels automatically. 
  

2. Cartoning Machine 

• Function: Packages bottles into cartons with informational leaflets. 

• Technology: Verifies pharmacodes on cartons and leaflets to ensure correct formats, rejecting any incorrect items. 

3. Second Labeling Machine 

• Function: Prints and checks serialized codes on cartons. 

• Technology: Retrieves unique serial numbers for accurate printing, with post-printing inspection to discard defective cartons. 

4. Top Load Casepacker 

• Function: Packs cartons into cases from the top. 

• Technology: Re-inspects carton codes before case insertion, ensuring accuracy in printing and inspection. 

  Subsequently, the system manages the printing and verification of codes and variable data on the case label, and performs the aggregation of cartons to the case. The pallet is then manually assembled by the operator, with case-to-pallet aggregation carried out using a handheld scanner.

Streamlined Serialization System 

SEA Vision offers a comprehensive and fully integrated serialization system, including both hardware and software solutions designed to ensure complete control over every stage of the production process. 

The serialization system integrates the following products: 

• Tracker: the Vision and Serialization System installed on each machine, guaranteeing serialization processes at machine level;

• Yutrace: the centralized Site System Level 3 allows for configuration and communication with third-party systems for serial number acquisition and regulatory compliance. 

  In this case, the Level 3 system communicates with a third-party Level 4 system to acquire serial numbers and manage commissioning activities with regulatory agencies.

• Reworkstation: A manual warehouse workstation used to execute rework activities and shipping operations. It enables operators to handle rejected or non-conforming products efficiently before they are shipped.

• Yudoo: the Pharma Software Suite that manages production orders and recipes, providing real-time views of production data and OEE. 

Results

The implementation of SEA Vision’s solutions yielded remarkable results for the pharmaceutical company: 

• Enhanced Efficiency: Automation and real-time monitoring reduced manual errors and boosted production throughput. 

• Improved Compliance: Reliable serialization and aggregation ensured adherence to regulatory standards. 

• Increased Traceability: Comprehensive data collection and reporting improved product traceability throughout the supply chain. 

Conclusion

Through the collaboration with SEA Vision USA, the pharmaceutical manufacturer successfully transformed their production processes, achieving higher efficiency, regulatory compliance, and end-to-end product traceability. 

From Semi-Automated to Fully Automated

This project marks a significant milestone for our client, transitioning from partially automated operations to a fully automated, integrated, and compliant pharmaceutical packaging solution.

Learn More

For further information about SEA Vision's serialization solution, visit:

• SEA Vision's Serialization Systems