DESCRIPTION Â
Sanofi Pasteur is in the process of formalizing its manufacturing sites to ensure business continuity and maximize back up for filling operations. The Sanofi Pasteur (Toronto site) desires to build a new vaccine facility which will be dedicated to the production of 5 Component Acellular Pertussis (5acP), Tetanus and Diphtheria. The New Bulk will manufacture these products up to the drug substance stage (Adsorption). This new facility will be designed to meet both current and future demand projections, while simultaneously resolving the safety and existing challenges of the existing facility. The New Bulk Facility project has as its objective the design, construction, commissioning and qualification / validation of a facility for the commercial manufacturing of 5 Component Acellular Pertussis (5acP), Tetanus and Diphtheria up to the drug substance stage. The Business requirement is to meet the 2025 Market Demand of 75M doses/ year with a facility Capacity of 100M doses per year. The facility contains two separate Production Areas for Pertussis and Diphtheria / Tetanus. Diphtheria and Tetanus will share the same Production area on a campaign bases, but will not share equipment. The two products will not be made at the same time in the Upstream (Live) Area, but production operation will overlap in the Toxin and Toxoid Areas. Additional shared spaces are used for media preparation, buffer preparation, washing and sterilization. Production suites are designed to meet CL2-Ls Guidelines.
Mechanical Systems
Kelson mechanical highlights: The Mechanical Objective of this project is to design an economical and highly efficient system capable of maintaining the clean environment required in a pharmaceutical facility. This objective is to be accomplished by providing new building utilities for Chilled water, heating hot water and using plant steam from the existing Cogen Plant. Based on the utility requirements, the following mechanical equipment shall be provided: Classified Areas – 12 air –handling units, Non GPM areas_ 3 air –handling units, Plant steam shall be provided from the existing site Cogen Plant, Four (4) new 700 ton water –cooled chillers and four ( 4) new open- circuit Cooling Tower shall be provided for the chilled water loop.