Meet the 2025 ISPE Facility of the Year Awards (FOYA) Category Winner for Operations – Operational Excellence: Johnson & Johnson Innovative Medicine – Italy
ISPE
Johnson & Johnson’s facility in Latina, Italy, is a small molecule manufacturing site for global launches and commercial supply of solid dosage forms. It is also the strategic launch and growth site for manufacturing and packaging of solids products. Johnson & Johnson Latina site’s diverse portfolio includes multiple therapeutic areas.
With more and more demand for specialized medicines for cancer, immune-mediated, and neurological diseases, Johnson & Johnson was faced with a challenge for flexible packing of tablets in bottles. Their previous machinery set-up for packaging of solid oral dosage forms was not suitable anymore. In collaboration with an equipment supplier, they designed and implemented a brand-new highly robotized packaging line.
The flexible bottle packaging line is designed and structured in modular cells: three cells dedicated to primary, secondary, and tertiary packaging. Each module is dedicated to specific packaging steps. All the cells are managed by a unique brain, a unique control system that controls the entire line and it is integrated with the upper-level systems to receive order, production data, and recipe, and to collect data from the shop floor at the same time. The line is composed of 17 robots in a row.
An overall improvement in performance is expected from the adoption of the flexible technology and approach.
Innovative Packing Line
The innovative design features a packaging line with no format parts, but the ability to pack a broad range of bottle sizes, making it especially suitable for high-value, small batch production. To achieve this, this unique system, unlike any other on the market, is managed by an advanced control system that oversees 17 robots, ensuring seamless automation and robotics integration.
Key Features
Flexibility and Adaptability: The modular design allows for easy customization, with each module dedicated to specific packaging steps across primary, secondary, and tertiary cells. This modularity enables quick adjustments to individual process steps.
Systems Integration: Fully integrated with upper-level site systems, the line efficiently handles batch data and recipes while collecting shopfloor data.
Rapid Product Changeover: Capable of managing any packaging configuration without the need for format parts or human intervention, the line guarantees changeovers in minutes, significantly faster than the current multiple-hours-long process. This feature also accelerates new product introductions.
Enhanced Quality and Compliance: In-line implementation of in-process control (IPC) ensures 100%-unit inspection.
Operations
The design of the line is for batches of less than 3000 bottles, 500 SKUs and 170 bottle configurations. This was achieved with a very compact and fully automated robotic line with 17 robots in total. The process covers primary (bottling), secondary (cartooning), and tertiary (palettizing) packaging. The line has no format parts and has reduced the change-over time from 6 hours to 45 minutes.
Supply Chain
The flexible packaging line allows for short delivery times, which accelerates the time to the patients.
This innovative machine design was developed from scratch and has significantly improved throughput of small to medium batch, while minimizing change-over significantly. It is for these reasons that this project has been selected as the FOYA Category Winner for Operations – Operational Excellence.
Supply Partners and Key Participants:
Manufacturer/Owner Name: Johnson & Johnson Innovative Medicine
Winners in this category exemplify the application of novel tools and approaches to delivering projects that improved efficiencies, overcame unusual challenges, promoted effectiveness, and organized stakeholders and project team participants in ways that led to successful outcomes such as efficiency, delivery, quality, product yield, consistency, and cost of goods. Projects demonstrate a culture of continuous improvement behaviors which yielded superior results. Additionally, these principles, systems, and tools ensure business continuity through stable supply environment, health and safety, and customer satisfaction from existing or new facilities, processes, and manufacturing operations.
Established in 2005, the FOYA program recognizes state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches.
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