2021 Category Winner for Facility Integration

Takeda Pharmaceuticals International AG

Location: Grange Castle, Ireland
Project: NINLARO The Grange Castle Factory P2 Facility

Facility Integration logo

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

The P2 facility is located at the Takeda site in Grange Castle, Dublin, Ireland, and broke ground in June 2017. The facility included drug substance manufacture (DS), drug product (DP) blistering and secondary packaging, quality control (QC) testing, and quality assurance (QA) operations in one dedicated building. The vision for the facility was for it to be: small, simple, safe, and integrated. The most novel concept of the four was the integration of the three facilities.

Due to the highly toxic nature of the API, the exposure to airborne materials was engineered out of the process using “Best Available Technology”. The outcome of the occupational exposure assessment for the API was Occupational Exposure Band 5 (OEB 5) with an occupational exposure limits (OEL) of less than 1 μg/m3. Controlling of OEB 5 compounds is extremely difficult and requires the highest level of containment that involves no open handling, closed transfers through validated systems, and the most skilled operators. The design intent of the facility was to use engineering controls to provide full protection to the people who work there in a “shirt sleeve” facility. The containment was achieved through the use of isolators for all potent operations. The isolators ranged from small solids charging isolators at the heads of vessels to isolators that enveloped large skidded equipment and unit operations. The IMA ADAPTA encapsulator was selected for the filling of the OEB 5 product. The full capsule process includes capsule filling, metal detection, and weight checking. The process is 100% integrated in the IMA ADAPTA which ensures the required containment level and also the accurate fill weight which is the truly critical quality attribute.

Cutting edge digital technology was applied in the NINLARO Facility. Operation of the plant will be completely paperless by using the PAS-X Manufacturing Execution System (MES) with equipment-integrated Electronic Batch Recording (EBR), which will also be integrated to SAP ERP (Enterprise Resource Planning) for seamless material supply chain management. The multitude of user e-signatures required for a typical electronic batch record will be reduced by the introduction of Nymi biometric authentication devices. These devices facilitate electronic signatures using wrist wearables and NFC readers. The MES system also provides the data for the real time digital performance management boards which tracks the overall performance of the plant.

  • Pipe rack and cooling installation
  • 2021 Category Winner for Facility Integration
  • VR Training-3
  • Takeda Ninlaro Grange Castle
  • Essential equipment for high containment facilities

Further, major steps were done in the area of Virtual Reality /Augmented Reality (VR/AR). A remote expert collaboration solution was established to provide operators support by remote experts using AR glasses. In addition, a virtual plant was developed for the facility. This enables the user to take a virtual reality tour of the facility from the comfort of their own home. Finally, VR training for aseptic practices developed with Innerspace and already deployed at various Takeda manufacturing sites will be utilized for training of shop-floor operators in the new NINLARO facility.

The Takeda NINLARO project is awarded the FOYA Award for “Facility Integration” as it exemplifies how application of good design practices and superior conceptual planning leads to excellent integration of facility and process, yielding to efficient, safe, and excellent processing outcomes.

Supply Partners and Key Participants:

Manufacturer/Owner Name - Takeda Ireland Ltd
Engineer/Architect (A&E)  - PM Group
Construction Manager - PM Group
Main/General Contractor - PM Group
Piping Subcontractor - Jones Engineering
HVAC Subcontractor - Dornan Engineering
Automation and Control Suppliers - Control & Information Management
Major Equipment Suppliers/Contractors:

  • Isolators - Howorth Air Technology
  • Reactors - 3V Tech S.p.A.
  • Isolator / Mill / Blender - Powcon
  • Filter Dryer - Powder Systems Ltd
  • Capsule Filling  - IMA Group
  • Blister line - Marchesini Group S.p.A