Breakdown of Works
– Installation of 2 × 10,000-litre glass line vessels to support manufacture of corrosive and standard buffers.
– Installation of 1 × 5,000-litre stainless steel vessel to support manufacture of alcohol and standard buffers.
– Future capacity vessel rooms designed to accommodate an additional 2 × 10,000-litre vessels depending on usage profile.
– Water for Injection (WFI) system upgrade.
– New mechanical and electrical services, including effluent treatment plant.
– Installation of new chilled water and compressed air systems.
– Installation of major equipment including aseptic filling machines, weighing and dispense booths, – pharmaceutical-grade washers, and autoclaves.
– Enabling works such as new access road and diversion of underground utilities.
Our Role / Scope
Acting on behalf of the client, our team provided comprehensive Business Analysis, Project Management and Validation Delivery services.
Business Analysis:
– Conducted in-depth evaluation of existing business processes across multiple workstreams.
– Delivered Gap Analysis, Operational and Process Flow mapping.
– Defined business and process needs to inform design and build stages.
– Identified opportunities for operational improvement to optimise efficiency.
Project Management:
– Oversaw implementation and construction activities through testing, commissioning, and handover.
– Acted as primary liaison between client and principal contractor.
– Provided consistent updates and coordination across all workstreams to ensure project delivery on time and within scope.
Validation delivery:
– Provided support for validation lifecycle documentation creation.
– Oversaw IQ,OQ and PQ qualifications on all manufacturing and process equipment.
– Delivered FMEA workshops on all process and equipment operations.
Project Team
– Project Director
– Business Analyst
– Project Manager
– Project Engineer
Project Impact
Through proactive business analysis, meticulous project management, and seamless coordination between stakeholders, EPS played a key role in delivering a complex pharmaceutical manufacturing facility expansion on time, within budget, and to the highest quality standards.