Sterile formulation, filling and packing lines – AstraZeneca
Published November 18, 2025
Client
- AstraZeneca
Locations
- Sydney, Australia
Core Capabilities
Process/mechanical design
Procurement & construction support
Commissioning
Qualification
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Project Summary
The project involved a production expansion for three new sterile formulation, filling and packing lines at AstraZeneca’s existing production facility in Sydney.
The Challenge
Synertec was engaged by AstraZeneca to provide consulting services for the new facilities which include Grade B, C and D cleanrooms, from detailed design through to procurement, installation, commissioning and qualification.
Key challenges included managing the construction of the new cleanrooms within an existing sterile manufacturing facility and integrating to the manufacturing area without affecting production activities.
The project scope involved:
- (3 + 2) x Formulation Suites (aseptic manufacture)
- (3 + 2) x BFS Filling and Packing Lines
- New Grade B Change Rooms
- Product contact utilities – WFI, PS, CA, CIP
Synertec's Solution
Synertec provided process and mechanical engineers on-site from detailed design through to qualification, supported by Synertec office–based resources for drafting and documentation. Synertec provide on-site procurement and construction support, including shutdowns and equipment relocation. Synertec engineers executed commissioning and qualification activities for facilities, process and product contact utilities.
Synertec’s Scope Included:
- Outsourced personnel – process & mechanical engineers
- Detailed design
- Procurement & construction supervision, including shutdowns
- Commissioning & qualification – facility / process / product contact utilities
- Equipment relocation
