Pharmaceutical Online Covers Honorable Mention FOYA Award Winner, Chugai Pharmaceutical Co., Ltd.
20 July, 2026
Chugai Pharmaceutical Co., Ltd. is advancing pharmaceutical manufacturing through extensive automation at its FJ3 active pharmaceutical ingredient (API) production facility, a project that was recently recognized with a 2026 ISPE Facility of the Year Awards (FOYA) Honorable Mention. The facility was designed to manufacture a diverse range of products—including macrocyclic peptides, small-molecule APIs, and highly potent compounds—while maintaining flexibility, quality, and operational efficiency on a global scale.
According to Chugai representatives, the company's automation strategy was developed to address several key industry challenges, including labor availability, production consistency, and the need to minimize human error. By automating manufacturing operations and routine inspections, the company has significantly streamlined workflows and allowed employees to focus on higher-value activities. Automation has also reduced reliance on manual valve operations and operator interventions, improving process reliability and helping ensure product quality and regulatory compliance.
A cornerstone of the FJ3 facility is its modular manufacturing design. Chugai structured production into standardized functional blocks, each corresponding to a specific unit operation such as charging, reaction, sampling, or cleaning. Automated sequences were developed for every block, enabling manufacturing teams to assemble flexible production recipes that can be adapted for different drug modalities. This approach allows the facility to handle multiple product types while maintaining a high degree of automation and operational consistency. The company says the closed and integrated production environment also strengthens data integrity and reduces the risk of process variation.
Automation extends beyond production processes to material handling and quality operations. Chugai implemented a fully automated warehouse management system that manages storage, retrieval, and material transfers, improving traceability and accuracy across the supply chain. Manufacturing operations are executed through standardized automated control sequences, while quality systems incorporate real-time monitoring, automated alarm management, and continuous data collection. These capabilities enable rapid detection of abnormalities and support proactive decision-making to maintain process reliability.
Despite the facility’s extensive automation, some tasks still require manual intervention. Weighing operations and powder charging into reaction vessels continue to be performed by operators, largely because these activities take place in explosion-proof environments where robotic deployment remains technically challenging. Additionally, equipment used for handling highly potent compounds requires rigorous cleaning and decontamination procedures that are difficult to automate while meeting strict validation requirements. Chugai has therefore adopted a risk-based approach that combines manual execution with robust procedural controls to ensure safety, containment, and consistency.
The facility’s automation architecture is built around an integrated distributed control system (DCS), primarily utilizing Emerson’s DeltaV platform. The DCS controls critical process parameters such as temperature and pressure while integrating operational data with the manufacturing execution system. This connection provides end-to-end traceability, aligns manufacturing instructions with execution records, and supports data-driven operations. Chugai also incorporated redundancy, alarm management, and automated safety shutdown functions to enhance system reliability and operational safety.
Company officials highlighted one of the project’s major lessons learned: the importance of involving cross-functional stakeholders early in facility design. By bringing together systems engineers, process engineers, and manufacturing personnel from the outset, Chugai was able to address automation, safety, risk assessment, and process design concurrently rather than sequentially. The collaborative approach helped reduce rework, maintain project timelines, and improve overall design quality.
Looking ahead, Chugai views automation as only one part of its broader digital transformation strategy. The FJ3 facility’s integrated systems generate real-time operational data that can be used to optimize performance, support troubleshooting, and drive continuous improvement. The project demonstrates how pharmaceutical manufacturers can combine automation, modular design, and digital technologies to create flexible, efficient, and globally competitive production environments—a vision recognized by its 2026 ISPE FOYA Honorable Mention distinction.
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Pharmaceutical Online is part of the Life Science Connect media group. The publication provides in-depth articles intended for professionals who are actively involved in the development, manufacture, packaging, and distribution of small molecule products that have been approved by the US Food and Drug Administration.