Eurofins Alphora CDMO - Hadwen GMP Biologics Manufacturing Expansion
MISSASSAUGA, ON, CA
A new 4-storey building addition for GMP biomanufacturing of pharmaceuticals to support the future growth of the Research and Development, Analytical Services, and Biologics business units across two floors, with base building shell provisions for the future fit-out of two additional laboratory floor areas. The new building will require the demolition of an existing single storey structure, and diversion/relocation of major mechanical and electrical passthrough services, including firewater, emergency power and natural gas. The design of the new mechanical and electrical systems will incorporate the project specific GMP requirements, including the relevant regulations of Canadian Regulatory Authorities, USDA and FDA.
New air handling and high plume exhaust systems, steam boiler plant, chiller plant, emergency generator system, clean compressed air system, and bulk nitrogen and oxygen systems are 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 and post-manufacturing processes, the mechanical and electrical design will interface and support utility provisions for Owner supplied equipment which includes sterilization autoclaves, temperature control units, clean steam generators, pure water (Water-for-Injection) system and wastewater neutralization system. All major mechanical and electrical equipment will be monitored and controlled via a new centralized building automation system, with a dedicated environmental monitoring system serving GMP areas for real time temperature and relative humidity monitoring and data logging.
Services Provided: Mechanical, Electrical and ICAT Engineering