Our facilities and infrastructure are designed to provide the highest level of support to our customers. State of the art manufacturing facilities provide for 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, our products and services meet the highest quality and regulatory standards. Uninterrupted and rapid product supply is critical, so Irvine Scientific is continually improving to meet the challenges our customers face.
QUALITY
Our extensive history supporting regulated products assures our practices thoroughly conform to the International Standard Organization (ISO) and United States Food and Drug Administration (FDA).
This knowledge is the foundation for our facility planning, comprehensive approach to validation, qualification and certification of methods, equipment, and processes. Our facilities are committed to:
Manufacturing Excellence• Redundant powder manufacturing sites (California, USA & Tokyo, 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
• High compendial grade components used
• Water for Injection (WFI) tested to USP requirements
Consistent Reliable Supply
• Industry leading turn-around time
• Manufacturing scalability
• Worldwide distribution with warehousing locations in USA, EU and Japan
• Cold-chain logistics
Irvine Scientific - California
The California, USA facility is our corporate headquarters and is located in Santa Ana. It supports a broad range of customers through liquid and powder manufacturing suites, a newly expanded research and development facility, quality control laboratory, dedicated temperature controlled raw material warehousing, and finished product distribution capacity.
Irvine Scientific - Tokyo
The Tokyo, Japan facility is a new state-of-the-art operation with powder manufacturing suites, research and development operations, quality control laboratories, dedicated raw material temperature controlled storage, customer support and finished product distribution capacity. It is designed to provide complete redundancy in milling equipment, raw materials, processes, and quality systems to our US site in order to ensure consistent supply and risk mitigation for our biopharmaceutical customers.
Irvine Scientific - Dublin
The Dublin, Ireland distribution facility is conveniently located to provide regional logistic and customer support.
