" class="no-js "lang="en-US"> FUJIFILM Irvine Scientific Begins Customer Qualification of European Manufacturing Facility - Medtech Alert
Monday, October 07, 2024

FUJIFILM Irvine Scientific Begins Customer Qualification of European Manufacturing Facility

FUJIFILM Irvine Scientific, Inc., today announced that it completed construction and started the commissioning phase of its new manufacturing facility in Tilburg, the Netherlands. The commissioning milestone marks the beginning of validating the facility and equipment in anticipation of full operations starting in late 2021. The new facility will join manufacturing locations in the U.S. and Japan to increase the production capacity of cell culture media products and provide a hub for European and global markets.

Despite challenges to supply chain and operations caused by the COVID-19 pandemic, delivery of essential equipment and construction of the new Tilburg facility progressed throughout 2020. Completion of a third, state-of-the-art manufacturing facility is an important step in the Company’s long-term plans to ensure its production capacity can meet the growing needs of the market and customers worldwide. Located in a key European position, the site offers customers more local supply, for increased efficiency, cost-savings in shipping, and secure supply chain.

Sustainability is also important for supply chain. Along with state-of-the-art Life Science manufacturing, the Fujifilm Tilburg site is designed for sustainable operation. The facility employs strategies that adhere to the Fujifilm Sustainability Value Plan 2030, including working towards a CO2-neutral status, using wind energy for the production process, and using sustainable technologies such as membrane bioreactors for wastewater purification.

The Tilburg facility occupies approximately 250,000 square feet previously utilized by FUJIFILM Manufacturing Europe B.V. to manufacture photo paper, offset plates, and membranes. The world-class facility will manufacture dry powder media, liquid media, buffers, and Water for Injection (WFI) in accordance with the same Quality System, raw materials, and expertise used in the Company’s facilities in the U.S. and Japan. Initially, it will increase the Company’s production capacity with greater than 320,000 kg/year of dry powder media and greater than 470,000 L/year of liquids, with the physical capacity to expand rapidly.

“While 2020 was a challenging year, we are pleased that our team succeeded in achieving this milestone on time,” said Yutaka Yamaguchi, chairman, and chief executive officer, FUJIFILM Irvine Scientific. “The new facility will enable FUJIFILM Irvine Scientific to meet increased global demand for cell culture media, as well as provide our European customers with a regional hub that delivers best-in-class cell culture media products and service.”

The site is intending to be an ISO 13485 certified manufacturing facility and follow CGMP, 21 CFR 820 for product manufacturing. It is ready to begin manufacturing qualification batches for customers to ensure it is ready to begin commercial manufacture on day one of commissioning. For information on qualifying the facility, visit https://www.irvinesci.com/fujifilmmanufacturing-europe-bv

View a video of the facility at https://www.youtube.com/watch?v=sifEYGwR4bQ

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