ANSTO (Health Products)
|Location inspected||Lucas Heights (LHSTC)|
|Date of inspection||29 – 30 March 2023|
An inspection was conducted as part of ARPANSA’s baseline 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 F0262.
The scope of the inspection included an assessment of ANSTO (Health Products) performance against the following areas of the Performance Objectives and Criteria (POC): Radiation Protection, Radioactive Waste, Ultimate Transfer and Disposal, and Protection of the Environment. The inspection consisted of a review of records, interviews, and physical inspection of the facility.
ANSTO’s Health Products facility is part of the greater Nuclear Medicine division at ANSTO (which also includes ANM) and forms part of ANSTO Nuclear Operations and Nuclear Medicine (OPAL, Nuclear Medicine and Waste Management Services).
It is a radiopharmaceutical production facility that primarily produces molybdenum-99/technetium-99m generators along with various other radioisotope products use for the treatment and/or diagnosis of disease including cancer.
It is considered that the current operational production facilities attached to the ANSTO Health Products licence are being managed in a safe manner. One area for improvement was observed in relation to safe transport of radioactive material and a good practice identified in relation to providing readily identifiable and specific radioisotope information.
A non-compliance has been identified in relation to passive waste storage in a non-operational facility. However, steps are being taken to address the areas of concern.
In terms of reporting on safety, ANSTO has a computerised event management system (GRC) in place which can be accessed by all staff. Any staff member may raise a safety event as well as see all other events raised. Procedures are in place describing the use of this system and how actions following events are managed. These documents are attached to each facility staff members’ curriculum in ANSTO’s learning management system. ANSTO Health Products also promotes hazard observation and opportunity for improvement reporting into GRC as part of their ‘see something, saying something’ principle, in addition to reported events or near misses. There are also various other mechanisms for safety reporting and discussion such as team or management meetings and toolbox talks, with some of these occurring on a daily basis.
A live dashboard exists on ANSTO’s intranet which is an open access system and can have its scope reduced by the user to specific areas of interest. This system allows the user to look at any ANSTO incident investigation by status, type, severity, month, as well as actions and findings. The dashboard piggybacks the GRC database for its information and is updated daily.
ANSTO also reports radiation and general safety incidents as well as operational incidents to ARPANSA in their quarterly report. A GRC number is provided with a general description, the date of occurrence and impact rating (both potential and actual). These can be followed up by ARPANSA’s regulatory officers on inspection or at the time of review.
As part of the portfolio of ANSTO Health Products, one of their facilities is currently in a non-operational state given its successor, the ANM facility, has been online for a number of years. Part of this facility is an underground tank farm which stores separate streams of both low level (LLW) and intermediate level (ILW) liquid waste from the molybdenum manufacturing process. Each tank sits in its own concrete bunker, which are lined both internally and externally with membranes designed to prevent ingress and egress of liquid. Each tank also has its own outer sleeve as a secondary layer to the inner tank to contain any potential leaks.
In mid-2022, following a submission made to ARPANSA regarding the tanks, a physical inspection was conducted by ANSTO where it was identified that a large amount of rainwater had entered the bunkers holding the LLW. Key issues identified as a result of this inspection are discussed below.
Issues were identified with two systems: the leak detection system and the level gauging system. The purpose of the first system is to detect the presence of any liquid (outside the inner tank) and generate audible and visual alarms. The second system is used as a cross check against expected change in waste level following a transfer to ensure against filling beyond capacity. This would then allow for recovery from an incident (i.e., a leak) to be properly planned and methodically executed and potentially, depending on the size of the leak, the gauge system could indicate the size of the volume reduction. If such a leak was to be detected, either in the outer sleeve or bund, there are other systems in place which are used to transfer that liquid to another tank.
It has been identified that neither of these systems were working as intended. Safety related items are subject to regular inspection, testing and maintenance to ensure that abnormal and emergency situations are detected and actions taken. Though the leak detection system was subject to testing, records from 2018 and 2019 indicate that, following an alteration made to the programmable logic controller (PLC) to avoid nuisance alarms, no alarms were being received by ANSTO’s site operations centre. This is one of the core functions of the system. There is also very limited or no documentation surrounding the change to the PLC, verification of the systems’ performance subsequent to the modification, or categorisation of significance to safety.
In addition, the level gauging system could only be used for one of the liquid waste tanks primarily due to the effect weather has on the liquid within associated piping, causing crystallisation of remaining waste material, making it difficult to determine the liquid level and hence waste volume. Since then, ANSTO has been able to determine the volume of waste within the tanks using that system. It is also important to note that records reviewed by ANSTO as part of their inspection activities identified that the two systems for recording waste volumes do not correlate with each other. This discrepancy was first identified in December 2020.
As recognised by the facility’s safety analysis report, failure of these systems is a compromise of defence-in-depth. It was not known, up until ANSTO’s physical inspection activities were conducted, that any liquid containing waste was present outside of the inner tanks. Had it not been for this physical inspection, these issues may have remained undetected. As such, these issues indicate non-compliance with section 60 of the Regulations requiring the licence holder to take all reasonably practicable steps to manage the safety of the facility.
Following identification of these issues, ANSTO has made several recommendations and work orders have been issued to solve them and bring the system back to its required functionality/reliability.
To date, there has been no actual safety consequence resulting from the failures of these systems. So while it is expected that containment features of the facility itself will continue to perform their intended functions, if a leak were to occur though contained within the facility, the presence of that leak would go undetected.
Apart from the above concern, no other issues were identified in relation to inspection, testing and maintenance or meeting surveillance requirements of safety related items attached to facilities as part of the F0262 licence.
In August 2021, ANSTO Health Products received approval to routinely produce rhenium-188. At that time ARPANSA’s Chief Regulatory Officer requested that, when production increased to a certain level, further supporting documentation be supplied to confirm the extrapolated results from initial hot commissioning works. Although the level of radioactivity has increased, no further information has been provided by ANSTO as requested. ANSTO explained that dosimetry activities were undertaken to confirm the original assumptions but a lack of resources was offered as the reason for not providing a report to ARPANSA. It is a rare occurrence that information is not received following a request.
ANSTO Health Products has also implemented a similar idea to ANSTO’s ANM facility in the display of informative signage. While ANM’s signage was a process flow for contamination response delineated by work area, ANSTO Health Products’ signage describes the isotopes in the specific location within the facility where the products are made. Information includes half-life, type of emission, energy, and multiple dose rates (external exposure from a point source and skin dose per MBq). Dose rate information and contamination monitoring equipment available to staff is also displayed. There are also plans to roll out this same signage in the QC areas given that staff are in close proximity to sample vials. This radiological information has never been so readily available to staff and as such, staff will now have a better understanding of the substantial difference in dose received when working with a source and potentially being contaminated where doses may be up to seven orders of magnitude different.
ARPANSA inspectors consider the purposeful placement of this information in the facility making staff aware of the hazard they face in a simplistic format to be an administrative improvement not seen at other facilities and as such is considered a good practice.
Radioactive waste management
Solid and liquid forms of radioactive waste are managed in a similar fashion in ANSTO’s Health Products facilities. While there are different mechanisms for capturing and isolating waste in production and QC areas (both shielded and unshielded bins which are also delineated by form i.e. solid versus liquid containing glassware, shielded containers for in-cell waste, liquid waste containers for active process waste, etc.), the process for removal is generally the same. Waste is collected and removed from the area as per the documented appropriate means and sent to the waste storage area for decay.
Once decayed to the appropriate level that allows for removal from the facility, Health Physics conduct a waste clearance survey which allows for ANSTO’s Waste Management Services (WMS) to collect the waste. WMS then conducts the required conditioning, treatment, packaging, etc., which may see the waste stored for decay or released as free waste.
Airborne discharges are described below.
Ultimate disposal or transfer
Though this POC is primarily concerned with radioactive waste from the conduct of the facility being associated with the production of radiopharmaceuticals, general transfer and disposal in accordance with section 65 of the Regulations was also covered as was the safe transport of radioactive material. Given that radioactive waste management is a separate POC, this section will concern the latter items mentioned above.
ANSTO Health Products is a radiopharmaceutical production facility and as such they continually supply Australian and international markets. Because of this, a licence condition has been placed on the F0262 licence which allows the licence holder to sell or supply certain radiopharmaceuticals without the need to apply for approval from the CEO of ARPANSA prior to doing so under the aforementioned section of the regulations. In addition, a separate condition of licence restricts the supply of these products ensuring that only those who are authorised to deal with them may receive them.
In selling these products, ANSTO is also concerned with their safe transport. As such, they are required to follow the Code for the Safe Transport of Radioactive Material (RPS C-2, rev. 1). ARPANSA inspectors reviewed procedures in place concerning the packaging and despatch of products and completed a walkthrough of the despatch area. No issues were identified.
ARPANSA inspectors also queried the use of certain transport packages. Previously, advice had been given from ARPANSA in relation to a previously certified package and its use. It has been identified that regulatory advice has potentially been misunderstood with the package in question being used without re-validation. Though its use continued without issue, ARPANSA inspectors reiterated the advice previously given to ensure that packages requiring validation or design approval certification are approved prior to use and that requirements of the transport code are adhered to. As such, this constitutes an area for improvement.
A request has been made by ANSTO for the re-validation of the aforementioned package.
An active ventilation system (AVS) is present in each of ANSTO Health Products’ facilities. The AVS, which operates at a negative pressure, ensures that extracted air from the production, QC and waste areas passes through high efficiency particulate air (HEPA) and charcoal (standard iodine adsorption module - SIAM) filters prior to being exhausted from the facility. This ensures that there is minimal radioactivity discharged into the air. Health Physics also monitors the air released from the facility via a stack through separate iodine cartridges.
Airborne discharge notification levels are placed on the ANSTO Health Products licence with the discharges monitored by ANSTO’s environment group. These notification levels are placed on the facility to ensure that for any controlled discharge into the environment at or below these levels, a member of the public will receive much less than the statutory dose limit. The discharges are reported by ANSTO to ARPANSA quarterly. Should a notification level be exceeded for a single isotope, ANSTO will inform ARPANSA and provide a report on what led to the discharge limit being exceeded and any potential resolution.
In addition to airborne discharges, there is the possibility that liquid radioactivity could be discharged from the facility as all sinks within the facility are considered to contribute to a radioactive waste line captured by ANSTO’s Waste Operations. This waste will only be discharged from site if decayed enough to meet the requirements of Sydney Water. However, though the sinks at the ANSTO Health Products facility are permitted to have a limited amount of radioactivity emptied into them, discharge of liquids at the facility is done via other means.
The inspection revealed the following non-compliance/s:
- The licence holder did not take all reasonably practicable steps to manage the safety of a facility described in the F0262 licence.
The inspection revealed the following area/s for improvement:
- Adherence to RPS C-2 (Rev1) Code for the Safe Transport of Radioactive Material with respect to revalidation of packages.
The inspection revealed the following good practice/s:
- Display of specific radiological hazard information in appropriate locations around the production facility.
It is expected that improvement actions will be taken in a timely manner.