Project Description

Multi Functional Support for Drug Substance Facility

Our client embarked on a large-scale vaccine drug substance project in Toronto, Canada and requested Project Delivery Partners Canada to support with project management, design management, CQ Management and Process Equipment CQ Execution as well as supporting other project functions. This project was a significant investment of over 600 million Canadian dollars, at the time the largest ever capital investment in our client’s history. The facility was designed to increase vaccine production capacity for highly infectious diseases such as diphtheria, tetanus and pertussis (or whooping cough) for 2025 onwards. The facility encompassed high end state of the art processing technology to produce the complex vaccines.

The scale of equipment for the process intensive facility is very complex, including but not limited to:

  • Facility surface area, approximately 161000 sqft
  • Approximately 27 miles of piping, include 15miles of process / clean piping
  • 15 HVAC and approximately 6 miles of duct (for Cleanrooms)
  • Approximately 800 pieces of equipment (including GMP equipment such as: fermenters, chromatography skids, ultra-filtration, centrifuges, process vessels, Purified water systems, WFI systems, clean steam, sterilising autoclaves and parts washers)
  • Approximately 120 PLC & Controllers, 21,000 I/O & 3,600 Instruments for a highly automated process

Project Delivery Partners were significantly involved in the initial project management & Commissioning and Qualification (CQ) Strategy including implementing the ASTM E2500 Risk based approach for C&Q of the facility and equipment.

PDP followed through to manage and execute in conjunction with the client end-users of the equipment for the commissioning and qualification execution phase for the project. The project was executed with a best in class safety programme for the critical C&Q / start-up phase.