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Stasons cutting-edge cGMP manufacturing capabilities include facilities from pilot plant and clinical scale production through to commercial batch manufacturing. The manufacturing facility is within a sprinkler-equipped concrete building, which encompasses approx. 37,0000 square feet and can produce over 2 billion oral doses per year with a batch size capacity of 0.5 kg - 600 kg. The clean (Class 100,000/ISO Class 8) rooms have a minimum of 12ft ceilings. The environment in the manufacturing rooms 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 and microbial levels) are 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. |
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