EllisDon was the Construction Manager for Sanofi Pasteur’s Toronto Building 100 facility that will produce Pertussis, Diphtheria and Tetanus bulk intermediate products destined for Canadian, US, European and other international markets.
The project included the delivery of a new three-storey facility that included process systems, critical and support utilities, building infrastructure systems and extension of campus steam, electrical power, communication, water and drainage services.
Primary production processes are on the second floor, within prefabricated cleanroom wall and ceilings, including up to Grade A (ISO-5 in operation) areas, and containment zones for biosafety (CL2-LS), toxins and spores.
Process areas include wash, sterilize, media & buffer preparation, and two parallel vaccine upstream/downstream process trains. The walk-on cleanroom ceiling provides full access to process, electrical, communication, controls and mechanical support services. The third floor includes buffer hold and transfer panels, technical & HVAC support services.
The first floor houses high purity water systems, clean steam and clean compressed air generation, clean-in-place; bio-inactivation, waste neutralization; changerooms, logistics, administration; central utility, HVAC, electrical & telecom/data/process control support. Critical utilities and process fluids are distributed throughout via a 16+ km pipeline network. Process and building automation include more than 5000 control points.
Scope of Services
The project demonstrates the collaboration between EllisDon and the Prime Consultant Integrated Project Solutions (“IPS”), regarding the design, construction, and commissioning of a large-scale pharmaceutical manufacturing facility in accordance with the current Good Manufacturing Processes (“GMP”) of aseptic process facilities. These processes include but are not limited to Process system walk down ahead of equipment and system qualification(s) and validation, validation of temperature/humidity control to clean rooms, HEPA filter installation/integrity testing/certification, cold storage and walk-in room start-up and Cx, and installation/validation of the equipment and systems process controls (Delta V). The facility requirements for CL-2 containment inside the clean room spaces were stringent and completed via Room(s) HVAC Differential pressure control validation through pressure regimen Integrated Systems Testing (to eliminate any potential cross-contamination inside clean rooms to adjacent spaces).
EllisDon also provided support documentation to Sanofi Pasteur in accordance with cGMP requirements for installation and verification of process line service types to equipment skids in accordance with federal regulations to satisfy the various Authorities Having Jurisdiction, including Health Canada’s HPFBI, the US FDA and European EMEA. These include cleaning and passivation reports, installation verification documents, and update of P&IDs and Isometric drawings of installed services (Purified Water/Water for Injection/Clean Steam/Clean in Place services/Media Buffer Systems, etc.) within the facility.
Preconstruction & Coordination of Design & Constru
Building Information Modeling (“BIM”) and the use of 3D design and coordination were instrumental in the success of this Project. The consultant team developed models for their disciplines and engaged in a 3D design coordination process. Key Subcontractors (Mechanical, Electrical and Process Piping) were onboarded early in a design-assist capacity, integrated with the design team to assist advance the level of detail of their models to construction. Owner-supplied process equipment skids were modelled as placeholders to refine points of connection to facilitate extensive coordination. Over 30 kilometres of process piping were modelled and coordinated during the course of this Project. A 20 ft. interstitial space above the lab floor required extensive coordination and collaboration by all parties. Over 200 major pieces of equipment were modelled to ensure systems could be coordinated and installed prior to delivery. These included tanks, large process skids, autoclaves, centrifuges, bio-Safety cabinets, fermenters, fume hoods, among others. Process skids were fabricated off-site by local and international vendors, delivered to the site, placed in finished rooms and tied in. Due to the size of some of these skids, it was imperative that the unit size, service connections (CHW/SW/PW/WFI/Steam) and floor mounting connections were all modelled to ensure rough-in could advance on-site while the equipment was being fabricated and when it arrived on-site it could be installed seamlessly without re-work.
BIM was also used to coordinate the placement of mechanical and electrical (“M&E”) devices in the prefabricated laboratory wall and ceiling panels installed in the production areas. This required extensive coordination between EllisDon, Sanofi, IPS and the Sub-Contractor working room by room to ensure that device placement was coordinated with equipment, met building code requirements and Owner user specifications. EllisDon and IPS engaged in Functional Specification page turn reviews throughout design and construction in order to ensure HVAC and Black Utility system Sequence(s) of Operations were meeting cGMP and facility requirements.
Over 200 pieces of equipment were delivered to the site and installed by the contractor. Fabrication times and subsequent delivery dates varied significantly depending on the size and complexity of the equipment. A meticulous planning and scheduling exercise was undertaken to promote Just in Time (“JIT”) delivery, ensuring that construction on-site was advanced to a level of completeness in order to accept equipment once delivered, minimizing the need for off-site or on-site storage where possible. Using the coordinated BIM equipment delivery pathways were established to ensure that once delivered to the site, the equipment could be placed in its final location. In many instances, this involved pre-planned openings in walls or postponing installation of non-critical M&E infrastructure until the skid could be placed.
The Last Planner System was used to carefully sequence the installation of building systems throughout the building, particularly in the interstitial spaces. The 30 ft. interstitial level was installed by areas in 10 ft. elevation blocks. Six weekly look-ahead meetings and daily huddles were used to sequence M&E installations, ensuring that work was made ready and handed off to the next contractor. Equipment deliveries and site logistics were also carefully planned through these meetings on a weekly basis.
The Owner validation and commissioning process required before production can commence can take up to one year after the building has been turned over for use. Therefore, early move-in was more important to this client than Substantial completion. EllisDon worked closely with Sanofi to hand over the building in small sections as areas became mechanically complete. This allowed the Owner to start the long commissioning and validation process of pieces of equipment and process systems ahead of the completion of architectural finishes. While this approach led to a significant number of changes and an increase to the schedule and budget accordingly, it put the Owner’s commissioning program on a good footing which is vital for the final validation and production of vaccines.
In addition to the equipment, the clean room assemblies were also prefabricated off-site, fabricated, delivered and installed once the site was ready. Specialized wall and ceiling panels were fabricated with coordinated mechanical and electrical raceways to account for equipment placement in rooms and Owner service requirements. This was facilitated by months of BIM coordination with Sanofi, the Design Consultants, EllisDon and the vendor.