Provision of Nuclear Medicine Facility Process Design & Design Integration and Process Design Peer Review

Summary and scope

Process Design and Design Integration services inclusive of: Process engineering Process architecture Integration of hot cells into the process line Preparation of specifications to support procurement of Specialist Equipment Vendors Contamination control strategy Specification and initial architectural design for areas that are in Good Manufacturing Practice (GMP) and Radiological Zones Design integration, including coordination of Building Designer and Major Equipment Vendor design works Engineering requirements tracing Reliability, accessibility and maintainability (RAM) GMP Compliance, and support in developing Therapeutic Goods Administration (TGA) approval and licencing documentation Process line commissioning and qualification plan development & commissioning support Process line validation support The general and overarching purpose of the Process Design Peer Review services is to provide independent, systematic, and documented assurance that the Facility design: Aligns with ANSTO project requirements and regulatory expectations; Demonstrates Good Manufacturing Practice (GMP) compliance and readiness; Incorporates robust radiation safety and contamination control principles; and Is technically coordinated and integrated across all design workstreams, including Process Design, Building Design, and MEV design