Dosage Form Capabilities

Dosage Form Capabilities

Located in Irvine California, Stason’s cutting-edge cGMP manufacturing capabilities include facilities from pilot plant and clinical scale production, through to commercial batch manufacturing. The manufacturing facility resides within a sprinkler-equipped concrete building that encompasses approximately 37,0000 sq. feet, and is capable of producing over 2 billion oral doses per year ,with a batch size capacity of 0.5 kg – 600 kg. The clean rooms(Class 100,000/ISO Class 8) have a minimum of 12 foot ceilings. The manufacturing rooms environments are designed to maintain a temperature of 18-24°C. The air handling system provides a minimum of 20 changes of filtered air per hour. The air quality (air particulate & microbial levels) is monitored periodically according to Stason SOP.

Stason also operates a dedicated High Containment facility, which is segregated from our Non-High Containment operations, and consists of multiple processing suites, a dedicated packaging room, a documentation room, and field support offices. The air handling system provides a minimum of 40 changes of filtered air per hour.

In addition to our solid dosage manufacturing capabilities (tablets & capsules), Stason offers injectable & liquid manufacturing through our partnership with Standard Chem. & Pharm. Co. Ltd. in Tainan, Taiwan. The Taiwan GMP facility located at Campus2 accommodates both liquids and ointments. The GMP facility on Campus1 is devoted to injectables and offers: lyophilization, suspension, powder filling, and liquids. For more information regarding our manufacturing partnerships in Taiwan, please inquire with us, inquiry@stason.com.