Confidential Healthcare Institution – Physical Therapy and Imaging Center
Brooklyn, NY
This ground-up facility at PCI Pharma/Lyophilization Systems of New England’s Bedford, NH campus features a complete cGMP production line designed for cytotoxic applications. It includes two 20M lyophilizers, along with supporting clean utilities and quality assurance laboratories, all housed within a 10,000 square-foot modular clean room that meets BSL-2+ requirements.
Due to stringent product specifications, the production line is enclosed in an isolator with precise tolerances for airflow, humidity, and temperature control. Shawmut managed the preconstruction, construction, and pre-validation phases for this state-of-the-art facility, ensuring compliance with all regulatory standards.