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

⁠⁠⁠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:

1. Aligns with ANSTO project requirements and regulatory expectations;
2. Demonstrates Good Manufacturing Practice (GMP) compliance and readiness;
3. 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

Other Instructions:

Refer to RFT Timetable for key events.

Conditions for Participation:

 Conditions for Participation:

 1. Suppliers must have acted in a Process Engineer and/or Process Architect role on a nuclear and/or pharmaceutical manufacturing project with a declared project value greater than $150M AUD within the last five (5) years. Credentials from parties subcontracting to the Tenderer will not be accepted.

 2. Suppliers must submit at least one Offer for either the Process Designer and Design Integrator (PDDI) services, or the Process Design Peer Review (PDPR) services. Tenderers may submit an Offer for both PDDI and PDPR.

 3. The Supplier must not be a joint venture.

 4. Complete and sign the Non-disclosure Agreement (NDA) in the form of Offer Schedule 23 Confidentiality Undertaking and return via email to the Contact Officer in accordance with the RFT timetable. The Supplier must nominate to the Contact Officer a responsible person (email and phone) for distribution of sensitive information via Aconex.

Timeframe for Delivery:

Refer to Approach to Market documentation.

Address for Lodgement:

Austender