Inspection report details
Licence holder: Australian Nuclear Science and Technology Organisation (ANSTO)
Location inspected: Lucas Heights, Sydney
Licence number: F0309
Date/s of inspection:7-11 December 2020
Report no.: R21/01231

An inspection was conducted as part of ARPANSA’s inspection program to assess compliance with the Australian Radiation Protection and Nuclear Safety Act 1998 (the Act), the Australian Radiation Protection and Nuclear Safety Regulations 2018 (the Regulations), and conditions of facility licence F0309.

The scope of the inspection included an assessment of ANSTO Nuclear Medicine’s (ANM) performance against the Performance Objectives and Criteria (PO&Cs) for Inspection Testing and Maintenance. The inspection consisted of a review of records for managing ANM, interviews, and a physical inspection of the facility.  


The ANM facility is used for large scale production of Molybdenum-99 (Mo-99). Mo-99 is the precursor of Technetium-99m (Tc-99m) which is used in 80% of all nuclear medicine procedures. The production process involves various steps including dissolution, purification, evaporation, dispensing and packaging of the product (Mo-99 solution).


ANM personnel and ANSTO Maintenance and Engineering (AME) personnel undertake Inspection, Testing and Maintenance (ITM) of the ANM facility. The maintenance schedule is maintained through SAP (Systems Applications and Products), which is a Computerised Maintenance Management System (CMMS). This includes preventative maintenance, breakdown maintenance, follow-up and investigation. ANM also uses this system for calibration tasks. The SAP system generates work orders documenting the tasks to be completed. These are then re-entered into SAP following completion of the required work. Supervision, lock-out, recommissioning and testing including sign-off requirements are all detailed on the SAP generated work order for each safety related and other preventative maintenance tasks as well. A record of all maintenance performed is kept in the SAP system. The inspectors sighted an example of completed work orders and found them comprehensive. Performance is also indicated through this system including asset utilisation.

ITM is undertaken using written and approved procedures and instructions in addition to work orders for each task. Workers undertaking ITM have the necessary competencies, are suitably trained and have the requisite experience and knowledge of the ANM facility.

External contractors provide a number of ITM services for the facility, for example, Kone Cranes provide an ITM service for the cranes within the facility. ANSTO uses a third-party contractor to register and verify qualifications and competencies of contractors undertaking work at the ANM facilities including ITM work that is important for safety or security. The web-based system can be interrogated by ANM management and appears to be an effective way of ensuring themselves of the qualifications, competencies, training and experience of contracted personnel. Contractor Supervisors within ANM or AME manage the safety of contractors and supervise their work through checklists and audits within the ANSTO business management system. The ANSTO procedure, Safe Management of Contractors (AP-2303) is used for management and supervision of contractors. The provision of inspections during works, monitoring and evaluation of compliance with relevant processes are included in this procedure.

The AME Policy requires that asset management systems and practices are based on international best practice and are subject to review and continual improvement through benchmarking, performance measurement, reporting, analysis, corrective actions, audits and management reviews.  ANM Mo-99 Facility Asset Management Plan (Q-50572) specify the activities, programs, resources, responsibilities, timescales and specific measurable outcomes required for assets to achieve asset objectives. Q-50572 classifies assets into the following asset sub-classes each of which consists of a number of separate plant systems and subsystems:

  • buildings, services & structures
  • hot cells and other shielded infrastructure
  • cranes, monorails and hoists
  • heating, ventilation and air-conditioning (HVAC)
  • active ventilation system (AVS)
  • electrical system
  • instrumentation & control systems
  • reticulated (in building) utilities including water, nitrogen gas, vacuum, electricity and compressed air
  • production equipment
  • analytical equipment

The equipment and items important to safety (such as hot cells, shielding, AVS, cranes) are clearly identified, categorised and documented within the ANM’s Safety Analysis Report (SAR). Items important for safety, maintenance, inspection and testing of safety functions are described throughout relevant parts of the SAR.

ANSTO utilises the documented procedure, Engineering Inspection and Test Recording Instruction (I-50675), for the recording of engineering inspection and test activities, which are often associated with change control or other activities which require the installation, operation or function of a piece of equipment or system to be verified. The process for defining the inspection and test steps required, and for recording of the associated results is described in this document. The responsibilities associated with engineering inspections and testing in relation to specific positions such as the Inspection and Test Planner, Inspection and Test Officer, Engineering Manager etc., are also described in this document. ARPANSA inspectors sighted the application of the change control process for Spare Gate Valve improvement and installation at DCEL1 (Dissolution Cell 1) as an example, and found the process comprehensive. Corrective maintenance records for repairing the failed gate valve of DCEL1 and the DPTE Door/lid jammed in DCEL1 were also sighted. The completed records were found in accordance with the ANM maintenance procedures and arrangements. 


The licence holder was found to be compliant with the requirements of the Act, the Regulations, and licence conditions. 

The inspection did not reveal any areas for improvement.

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