FUJIFILM Irvine Scientific’s facilities and infrastructure are designed to provide the highest level of support to its customers. State-of-the-art manufacturing facilities provide for the redundancy of manufacturing and quality systems while enhancing our capacity. From highly regulated medical environments, to basic research, to commercial stages of therapeutics and vaccines — FUJIFILM Irvine Scientific’s products and services meet the highest quality and regulatory standards. Because uninterrupted and rapid product supply is critical, FUJIFILM Irvine Scientific is continually improving to meet the challenges facing our customers.
FUJIFILM Irvine Scientific’s extensive history in supporting regulated products assures its practices thoroughly conform to the International Standard Organization (ISO) and United States Food and Drug Administration (FDA). This knowledge is the foundation for FUJIFILM Irvine Scientific’s facility planning, comprehensive approach to validation, qualification, and certification of methods, equipment, and processes. FUJIFILM Irvine Scientific’s facilities are committed to:
- Redundant powder manufacturing sites (USA, and Japan)
- Scalable manufacturing technology
- Dedicated animal-component-free manufacturing
- Powder and liquid manufacturing suites
Industry Best Practices
- Sourcing and qualification strategies, along with supply chain management
- Use of multi-compendial grade components
- Water For Injection (WFI) tested per USP requirements
Consistent Reliable Supply
- Industry leading turn-around time
- Manufacturing scalability
- Worldwide distribution with warehousing locations in USA, Europe, and Japan
- Cold-chain logistics
FUJIFILM Irvine Scientific - California
The USA facility is FUJIFILM Irvine Scientific’s corporate headquarters, located in Santa Ana, California. This facility supports a broad range of customers through liquid and powder manufacturing suites, a newly expanded R&D facility, a quality control laboratory, dedicated temperature controlled raw material warehousing, and a finished product distribution capacity.
FUJIFILM Irvine Scientific - Tokyo
The Tokyo, Japan facility is a new state-of-the-art operation with powder manufacturing suites, R&D operations, quality control laboratories, dedicated raw material temperature controlled storage, customer support, and a finished product distribution capacity. This facility is designed to provide complete redundancy in milling equipment, raw materials, processes, and quality systems to its USA site to ensure consistent supply and risk mitigation for our biopharmaceutical customers.
Fujifilm Manufacturing Europe BV
FUJIFILM Irvine Scientific manufacturing is coming in late 2021 to Europe with the same Quality System, raw materials, and expertise you expect from our facilities in the US and Japan — now in Tilburg, Netherlands. Construction was completed in mid-March and validation of the facility and equipment is underway.