Nuclear Medicine Manufacturing Facility - Safety Analysis Report

Overview The Australian Nuclear Science and Technology Organisation (ANSTO) is seeking to engage a suitably qualified and experienced consultant to provide Safety Analysis Report (SAR) consulting services for the Nuclear Medicine Manufacturing Facility (NMMF) project at Lucas Heights, NSW. About The NMMF will replace ANSTO's existing radiopharmaceutical manufacturing facility (Building 23) at Lucas Heights and support the long term supply of nuclear medicines for Australia. The services are expected to support multiple licence application packages associated with the design, construction and operation of the NMMF, a nationally significant nuclear medicine manufacturing facility. Purpose The successful consultant will be responsible for developing, coordinating and maintaining the overarching Safety Analysis Report (SAR) and associated Plans and Arrangements (P&A) required to support staged regulatory licence applications to the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA). The consultant will work collaboratively with ANSTO consultants and other project stakeholders to develop a comprehensive safety case for the facility in accordance with applicable ARPANSA regulatory guidance and ANSTO requirements. Scope The scope includes: Developing the SAR and P&A documentation to support the regulatory licence applications for the NMMF, including any supplementary submissions for licence applications and the associated staged approvals for Structures, Systems and Components important to safety Preparing the NMMF Safety Analysis Report (SAR) to support regulatory submissions, including collation of all supporting documentation, for all NMMF regulatory licence applications in alignment with the Safety Assessment Process Model, including any supplementary submissions required Preparing the NMMF Safety Analysis Report (SAR) in accordance with the ARPANSA Regulatory Guide, Preparation of the safety analysis report for non-reactor facilities (ARPANSA-GDE-1925) Developing, reviewing and updating existing Plans and Arrangements (P&A) documents required to facilitate development of the Safety Analysis Report, including an Effective control plan, Safety management plan, Radiation protection plan, Waste management plan, Emergency management plan, Environmental protection plan, Decommissioning plan, and Security plan Consulting with all applicable stakeholders in the development of deliverables Preparing the NMMF Safety Analysis Report and P&A documents free of error and to a professional standard suitable for regulatory submission Proactively supporting the NMMP Project team to secure ANSTO approvals to submit the regulatory licence applications Proactively supporting ANSTO in managing, collating and preparing Request for Approval (ARPANSA-FORM-1720WEB) documentation Supporting ANSTO in securing licence approvals from ARPANSA Developing a Services Management Plan within one (1) month of engagement, inclusive of the minimum requirements set out in Appendix F Developing a Quality Management Plan within one (1) month of engagement, inclusive of the minimum requirements set out in Appendix G Developing the deliverables list and deliverables strategy for all regulatory Request for Approvals required for the Facility, and supporting ANSTO in preparing the relevant form (ARPANSA-FORM-1720WEB) including documentation required to support regulatory approval Regulatory Approval Strategy (licence packages supported) Construction Licence Package A: NMMF Bulk Excavation & Piling, providing consent to excavate the site and install in-ground structures Construction Licence Package B: NMMF Shell and Core, providing consent to construct in-ground services and utilities, the building structure, the facade and the roof Construction Licence Package C: NMMF Facility and Services, providing consent for all remaining construction works, including all non-structural internal walls (including clean rooms, labs etc.), services, utilities, and installation of all equipment excluding the Radiopharmaceutical Manufacturing Lines Construction Licence Package D: Radiopharmaceutical Manufacturing Lines, providing consent to install and commission the process equipment and containment structures required to support active receipt and the manufacture of Technetium-99m, Lutetium-177, and Iodine (both sterile and non-sterile) products Operational Licence, providing approval to undertake hot commissioning activities and operationalisation of the Facility for all production lines Contract Terms and Conditions Indicative timing for the licence packages is as follows: Construction Licence Package A: NMMF Bulk Excavation & Piling, Q2 2027 Construction Licence Package B: NMMF Shell and Core, Q4 2027 Construction Licence Package C: NMMF Facility and Services, Q2 2028 Construction Licence Package D: Radiopharmaceutical Manufacturing Lines, Q1 2028 Operational Licence, 2032 Eligibility The Tenderer must have been the primary author of a SAR, approved by ARPANSA or an equivalent regulatory authority, on a major project of substantial size and similar nature within the last five (5) years. Credentials from parties subcontracting to the Tenderer will not be accepted The Tenderer must not be a joint venture Instructions to Tenderers The Tenderer must complete the Non-disclosure Agreement (NDA) in the form of Offer Schedule 23 Confidentiality Undertaking and return it via email to the Contact Officer in accordance with the RFT timetable The Tenderer must nominate to the Contact Officer a responsible person (email and phone) for distribution of additional information via email See the indicative timetable in the ATM, Part A See the timeframe for delivery in Part F, Specification Submissions are to be lodged electronically via AusTender (www.tenders.gov.au) Enquiries Jordan Lay: layj@ansto.gov.au