2025 ISPE FOYA Category Winner for Operations – Operational Excellence | ISPE | International Society for Pharmaceutical Engineering

Johnson & Johnson Innovative Medicine

Location: Latina, Italy
Project: Flexible Bottle Packaging Line

Executive Summary

The Latina, Italy site of Johnson & Johnson is a global launch site, which also provides commercial supply. With more and more specialized medicines in various therapeutic areas (e.g., oncology, immunology, neuroscience, infectiology, and cardiopulmonary diseases), Johnson & Johnson was tasked with developing a flexible packaging solution for putting tablets into bottles. The existing machinery setup was no longer suitable for secondary packaging of solid oral dosage forms, so the team decided to collaborate with an equipment supplier to develop and implement a brand-new design of a highly robotized packaging line.

Innovative Packing Line

The innovative design features a packaging line with the ability to pack a broad range of bottle sizes, making it especially suitable for high-value, small batch production. To achieve this, the team set up a unique advanced control system which is unlike any other on the market. The new system ensures seamless automation with robotics integration including the oversight of 17 robots.

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, which is significantly faster than the current hours-long process. This feature also accelerates new product introductions.
Enhanced Quality & Compliance: In-line implementation of in-process control (IPC) ensures 100% unit inspection, boosting compliance with cGMP standards.

Operations

The design of the line is for batches < 3000 bottles, 500 SKUs and 170 bottle configurations. This has been 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 has significantly improved throughput of small to medium batch, while minimizing change-over drastically. It is for these reasons that this project has been selected as the 2025 ISPE FOYA Category Winner for Operations – Operational Excellence.