In 2004 Cambridge Major opened a new, state-of-the-art 60,000 square foot GMP facility. The site has all of the capabilities required to provide API development and manufacturing services from early pre-clinical to post-NDA commercial production. The facility has a wide range of technologies including plant scale hydrogenation and cryogenics (-90C).
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General features of the Germantown, Washington Drive site are as follows:
- 4 Process R&D Laboratories (glassware to 50L)
- 5 GMP Kilo Lab Suites (glassware to 50L)
- 4 GMP Plant Process Areas (26 reactors from 50 gal to 500 gal)
- 3 Separate Analytical/QC Laboratories
- 3 HEPA Filtered Drying Suites
- 1 HEPA Filtered Packaging Suite
- ICH Stability Chambers
- GMP Storage/Warehousing Areas
The facility incorporates all of the latest technologies for HVAC and Process control. The HVAC systems are controlled by a Building Automation System (BAS) which monitors the temperature, pressures and humidity of the processing areas (labs and plant). Each processing area contains its own Air Handling Unit with once-through air. |
CML-US Equipment List
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