Client: BioVectra Inc.
Location: Windsor, NS
Construction Cost: over $30,000,000
BioVectra operates several contract pharmaceutical manufacturing facilities in PEI and Nova Scotia. Facilities include offices, warehousing, research, development, and manufacturing operations conducted in accordance with the requirements of Canadian and US FDA and EU regulations.
- MCA Consultants has worked closely with the BioVectra Engineering group to deliver numerous capital projects at their various sites. The Windsor site is presently undergoing a ~15,000 sq.ft. expansion of their fermentation and down-stream processing operations to expand their biological drug production capabilities. For this expansion project MCA was engaged at the conceptual design stage (BOD, PFDs, Preliminary PIDs, budgets) for a biopharmaceutical drug substance production process.
- Subsequent to preliminary engineering MCA has been acting as the prime consultant and owners engineer, managing and supporting the development and integration of designs from two remote process design groups and several local consultants (Structural, Civil, Architectural, Fire Protection). System design, construction, and qualification interface management between the numerous consultants required careful assessment and control to ensure all system designs and construction/commissioning activities were clearly defined; thereby creating continuity from design through to operations.
- In addition to acting as the owner’s engineer and design integration group, MCA is providing detailed design of all central utility plants and distribution/integration of all process equipment to the facility utility services. Integration and coordination of all piping and equipment into the facility is being accomplished through coordinated 3D facility and systems modeling.
- MCA is also providing full-time on-site construction oversight, contract administration support, coordination of trades, and confirmation of system installation relative to design documents, models, and specifications to ensure GMP requirements of completed systems will be met. Commissioning, system assessments, and IQ/OQ support of all systems designed within MCA’s scope is also being provided by MCA.
- This project presented numerous challenges as the existing facility had significant space limitations and existing utility services requiring increased capacity and expansion of the distribution networks. Existing equipment and piping removals and system tie-in were also closely coordinated with ongoing plant operations; GMP compliant fermentations continued in the facility during demolition and construction work in directly adjacent areas. Additionally, much of the new process equipment was purchased used from international sources and proper assessment, re-fit, and registration with local was required in nearly all cases. The schedule is also extremely aggressive to meet demanding production deadlines for the large pharmaceutical clients engaged by BioVectra.