2024 ISPE FOYA Category Winner for Social Impact

Chugai Pharma Manufacturing Co., Ltd.

Location: Tokyo, Japan
Project: UK4 Project

UK4 is a biological drug substance manufacturing facility that was designed and built under a “Three Zeros for Sustainable Development” concept. The three zeros encompass: 1) zero halogenated hydrocarbons, 2) zero natural gas, and 3) zero CO₂ (in non-GMP areas)

This new 40,000-square foot facility was specifically designed for the manufacture of early-stage investigational medicinal products. It consists of a four-floor production building with office space and material storage on the first floor, manufacturing areas on the second and third floors, and utilities on the fourth floor and roof. The culture room houses 50, 500, and 2000 liters of single-use bioreactors and has two 2000 liters of production-scale single-use bioreactors.

UK4 employed innovative solutions to achieve “Three Zeros for Sustainable Development.” To achieve the zero halogenated hydrocarbons goal, they used naturally occurring coolants like NH₃ and CO₂ instead of the traditional halogenated hydrocarbons. The cooling source is provided by Ammonia chillers while the heating source is provided by CO₂ heat pumps.

To avoid using natural gas, they installed electric boilers to supply the needed steam. This was possible, in great part, due to several design decisions that resulted in a reduction of steam demand like the use of CO₂ pumps as heat sources, the high utilization of single-use equipment eliminating the need for cleaning, and sterilization and the adoption of membrane-based process water system (cold WFI system) instead of a distillation-based equipment.

To achieve the last goal of zero CO₂ in non-GMP areas, UK4 implemented several solutions to reduce energy consumption and to generate what was needed using renewable sources. Solar panels were installed not only on the roof but were integrated as part of the façade of the building. The northern façade feature louvers optimized for blocking direct sunlight. These movable louvers not only block direct sunlight but redirect natural light into the clean rooms. Several additional energy management solutions were implemented across the site including adjustments to rooms air changes based on load, lighting control based on occupancy and other innovative solutions.

Finally, a water reuse strategy was implemented recovering rainwater, HVAC condensate, and production wastewater to reduce water consumption and the energy needed to produce it. All of this is monitored by a centralized energy and environmental monitoring system to ensure proper operation and validate efficiency.

This project is without a doubt a model for sustainable design. By employing innovative and interconnected solutions, Chugai has been able to deliver in UK4 a greenhouse-gas-free manufacturing facility ready to fulfill their mission of manufacturing the potential medicines of the future.

For these reasons, Chugai Pharma Manufacturing Co., Ltd. is recognized as the 2024 ISPE FOYA Category Winner for Social Impact, Sustainability.