2021 Category Winner for Process Intelligence and Innovation

Takeda Pharmaceuticals International AG

Location: Hikari, Japan
Project: Packaging Building and Automatic Line Clearance 

2021 Category Winner for Process Intelligence and Innovation

Takeda, founded in 1781, is a patient-driven, R&D focused  pharmaceutical company with headquarters in Tokyo, Japan. It’s mission is to strive towards better health for people and a brighter future for the world by leading innovation in medicine.

Takeda`s F36 New Solid Pharmaceutical Production Building in Hikari, (Japan,) is a 4-story building designed to elevate pharmaceutical packaging operations to a new industrial standard. Highly automated end-to-end packaging equipment including “end of line” case packers, Automated Guided Vehicles (AGVs), and robots to feed the Automated Storage & Retrieval System (ASRS) were installed.

Key technologies included a paperless Manufacturing Execution System (MES), Overall Asset Effectiveness (OAE) live 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. The paperless vertical integrated MES, smart operations using tablets and digital support systems, and the introduction of the operator voice instruction system has created a best-in-class operation.

Maximum efficiency was achieved through the introduction of the Automatic Line Clearance system (ALC). The ALC is cutting edge technology in pharmaceutical packaging processes and testifies to the highly innovative thought behind it. Takeda developed and implemented, as the first pharmaceutical company in a commercial packaging facility, an automatic line clearance system with 360° cameras, laser sensors, and dry run mode utilizing artificial intelligence (AI). From its development to a GMP compliant system, it 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 state of the art technologies currently used in the industry.

At a global level, Takeda's Global Manufacturing and Supply organization is a frontrunner in our industry for experience-based learning using Virtual Reality (VR) technology. In partnership with Innerspace, VR training for aseptic practices was developed and deployed at various Takeda manufacturing sites. A cutting-edge training room was built and fully equipped in Hikari’s building F36. 

The strategic use of digital and automated systems in the design solution has produced a state-of-the-art packaging facility with increased safety, quality, and overall efficiency. The outcome provides a “first time right” packaging operation, greatly reducing the possibility of potential human errors and the likelihood of product mix ups between batches. This achievement was made possible through strict adherence to Quality by Design (QbD) principles embedded in the project design and execution, leading to a highly compliant facility that is certain to positively impress regulatory authorities and inspectors.

  • Process Intelligence and Innovation - Takeda Pharmaceuticals International
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The Takeda F36 project is recognized with the 2021 ISPE FOYA Award for “Process Intelligence and Innovation” as it exemplifies how novel application of commercially available and custom developed process manufacturing tools yields superior results, advanced process understanding, and improved competitive position.

Supply Partners

Manufacturer/Owner Name – Takeda
Engineer/Architect (A&E) - Obayashi Corporation
Construction Manager - Obayashi Corporation
Piping Subcontractor - SANKI ENGINEERING CO., LTD.
Automation and Control Supplier - KURIHARA KOGYO CO., LTD.
Major Equipment Suppliers/Contractors:

  • Blister Machine Supplier - CKD Corporation
  • Cartoner & Caser Supplier - Kyoto Seisakusho Co., Ltd.
  • Form-Fill-Seal Machine - Omori Machinery Co., Ltd.
  • Line Clearance System Developer - MicroTechnica Co., Ltd.
  • Logistic System Suppler - Murata Machinery, Ltd.
  • SCADA & MES Solution Supplier - Hitachi Kansai Area Operation