As the prime consultant, BKM provided design services for clean rooms and support spaces including Class 100 (ISO 5), Class 1,000 (ISO 6), and Class 10,000 (ISO 7) clean room spaces for FDA-regulated pharmaceutical manufacturing and aseptic filling. The ISO 6 clean room including specialized gas-fired desiccant dehumidification equipment to achieve a space environment of 59 degrees Fahrenheit at 50 percent relative humidity.
Air handling equipment dedicated for the cGMP spaces is served by chilled water and heating water available from the building’s central power plant. Custom designed Class 100 workstations are provided within the ISO 7 clean room for aseptic filling locations.
Support spaces included process kettles, HTSTs, lyophilizers, pass-through autoclaves, and other specialized equipment. Non-GMP spaces are provided with separate air handling equipment to segregate air distribution and maintain proper space pressurization for the entire project area. All critical environment, safety and pressurization controls were added to the existing DDC system serving the building to monitor and control the systems and spaces within the design parameters.