Eurofins Alphora CDMO - Hadwen GMP Biologics Manufacturing Expansion & Level 3 and Level 4 R&D, Analytical and Microbiology Laboratory Fit-Out
MISSASSAUGA, ON, CA
A new 120,000 sq.ft. 4-storey building addition for GMP biomanufacturing pharmaceuticals to support the future growth of the Research and Development, Analytical Services, and Biologics business units, with base building shell provisions for the future fit-out of two additional laboratory floor areas. To accommodate the new building, an existing single storey structure was demolished, and diversion/relocation of major mechanical and electrical passthrough services, including firewater, emergency power and natural gas were performed. The design of the new mechanical and electrical systems incorporated client specific GMP requirements, including relevant regulations of Canadian Regulatory Authorities, USDA and FDA.
New air handling and high plume exhaust systems, a steam boiler plant, chiller plant, emergency generator system, clean compressed air system, bulk nitrogen and oxygen systems, water for injection (WFI) were provided to support the proposed laboratory functions. Specialty high pressure clean steam and clean compressed air systems were also provided and designed according to AMSE Bioprocessing Equipment Standards to control the level of fluid purity and bioburden in the biopharmaceutical manufacturing processes. To support the pre/post-manufacturing processes, the mechanical and electrical were design to interface and support utility provisions for Owner supplied equipment including sterilization autoclaves, local temperature control units, clean steam generators, pure water (Water-for-Injection) system and wastewater neutralization system. All major mechanical and electrical equipment is monitored and controlled via a new centralized building automation system, with dedicated environmental monitoring systems serving GMP areas for real time temperature and relative humidity monitoring and long-term data logging.
Through the course of design, the level 3 and level 4 laboratory fit out was added to the scope of work. The fit out included new research and development spaces, analytical, microbiology and chemical laboratories and administrative support spaces. The laboratory spaces contained Type B2 biosafety cabinets, chemical & acid digestion fume hoods with purpose-built corrosion resistant exhaust systems, incubators, storage fridges/freezers and sterilization autoclaves. New air handling and high plume exhaust systems, and bulk gas cylinder storage for helium, argon, acetylene, nitrous oxide and hydrogen are provided to support the proposed laboratory functions. In addition to the above, the mechanical and electrical design incorporated provisions for owner supplied equipment which included a turnkey ISO-6/7 clean for product sterility testing.
Services Provided: Mechanical, Electrical and ICAT Engineering
