The Facility of the Year Awards (FOYA) Process Intelligence & Innovation Category recognizes projects for their novel application of process manufacturing techniques, applied science-based solutions, and/or commercially available and custom developed equipment which yielded superior results, improved competitive position, and/or demonstrated imaginative collaboration with vendors/suppliers/manufacturers. This category also recognizes application of one or more digital innovations like automation, robotics, digital twin, or advanced processing understanding.
This is one of two Facility of the Year Awards Takeda won in 2021. They also won a FOYA in the Facility Integration category for their Grange Castle P2 Facility project in Dublin, Ireland.
Project: F36 New Solid Pharmaceutical Building and Automatic Line Clearance
As the first pharmaceutical company in a commercial packaging facility, Takeda developed and implemented an automatic line clearance system (ALC) with 360° cameras, laser sensors, and dry run mode utilizing artificial intelligence (AI). From development to a GMP compliant system is already a remarkable success story, but to standardize the technology and issue it as "off the shelf” technology, positions the ALC as one of the most important improvements in the pharmaceutical packaging industry today and elevates Takeda’s packaging operation significantly higher than comparable technologies currently used in the industry. The project exemplifies how novel application of commercially available and custom developed process manufacturing tools yields superior results, advances process understanding, and improves the competitive position.
Elevating Automation to the Next Level
Takeda’s F36 Solid Pharmaceutical Production Building in Hikari, Japan, is a four-story building designed to elevate pharmaceutical packaging operations to a new industrial standard. Active pharmaceutical ingredients, drug products, injectable liquids, pre-filled syringes, lyophilizates, injection infusions, and high-potency drugs are produced and packaged at the site. Nine of Takeda’s brands are produced at Building F36 for distribution across Japan with anticipated worldwide distribution soon. Cutting-edge technologies were used throughout the building design and operations that help Takeda make and package medicines more efficiently and safer than ever before.
Line clearance is a requirement for GMP as it is essential that equipment and work areas are free from previous products, documents, or raw materials. Traditionally the line clearance is performed by fully manual interactions, which can lead to mistakes since operators cannot get under the machine to fully inspect it. To solve this problem, Takeda developed an automatic line clearance with 360o cameras, laser sensors, dry run mode, and artificial intelligence (AI) software.
A typical line clearance that took 30 minutes before can now be done in 10 minutes. Additionally, the AI software can teach itself to differentiate between good and bad conditions to help it avoid false good or bad results.
Cutting edge Pharma 4.0 technology was used throughout the facility including a paperless Manufacturing Executing System (MES), Overall Asset Effectiveness (OAE) line visualization system, Supervisory Control and Data Acquisition (SCADA) system for full data acquisition, and “ready to go” digital operator voice instruction systems that raised the project to a new standard of packaging operations. F3 also has highly automated end-to-end packaging equipment including “end of line” case packers, Automated Guided Vehicles (AGVs), and robots to feed the Automated Storage and Retrieval System (ASRS). It is also home to a cutting-edge Virtual Reality (VR) training room.
“The reduction of potential human error to a minimum using automatic packaging equipment, MES and SCADA systems, AGVs, Smart Operations, and the outstanding technology of the Automated Line Clearance system is best-in-class,” said Masahiro Kondo, Senior Director Inspection & Packaging, Hikari Plant. “These systems also reduce the amount of necessary operator manual interaction with the packaging line to a minimum, thus greatly improving operator safety. Altogether, this is an incredible translation of quality, GMP, and safety requirement into futuristic technologies that has been realized today.”
Nominate Your Facility for the 2022 FOYA Program!
Apply for a chance to join this prestigious list of innovative game-changers and let ISPE honor your organization as a 2022 FOYA program winner. Applications must be submitted by 19 November 2021.
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