ANSTO, Australian Synchrotron, Cyclotron, Nuclear Medicine, PET-CT, Radiopharmaceutical and Theranostics HVAC Duct Guide — ARPANSA RPS 8, AS 2243.4, ASHRAE 170, ISO 14644

Why nuclear and radiopharmaceutical HVAC carries the highest engineering burden of any healthcare ductwork

A radiopharmaceutical manufacturing facility, a cyclotron PET production suite, a theranostics treatment dispensary or a research nuclear facility licensed under the ARPANS Act 1998 carries the highest engineering burden of any healthcare HVAC scope. The reasons are intrinsic to the work. The product is radioactive at production-relevant activity. The operator absorbs measurable dose every shift and the cumulative occupational exposure is recorded by personal dosimeter and reviewed against the ICRP 103 limits of 20 millisieverts per year averaged over five consecutive years with no single year above 50 mSv. The public-facing release pathway is the building stack and any duct leak between the radioactive containment and the public-occupied building envelope contaminates the surrounding facility. The waste, the activated carbon trap, the spent HEPA, even the duct itself at end of life is a radioactive waste consignment under ARPANSA RPS 5 with consignment paperwork, shielded transport and licensed disposal. Get the HVAC right and the facility operates safely for forty years; get the HVAC wrong and the cost is paid in operator dose, patient dose, regulatory non-conformance, licence suspension and remediation under the supervision of the federal regulator.

The discipline is unforgiving. A cyclotron PET production suite produces F-18 fluorodeoxyglucose at 110-minute half-life. Within four hours of cyclotron beam, the produced activity has dropped by 10-fold; within eight hours by 100-fold. The radiochemistry must finish, the dispensary must label, the courier must deliver and the patient must scan within a window measured in hours. The HVAC sustains this throughput continuously without dropping pressure cascade, without failing HEPA integrity, without exceeding stack release limits, without operator dose exceedance, batch after batch, day after day, year after year. A radiopharmaceutical dispensary handling I-131 for thyroid imaging or theranostics handles an isotope at 33 Becquerels per cubic metre derived air concentration — one of the lowest occupational airborne radionuclide limits in the Australian inventory because of the thyroid uptake risk and the disproportionate effect on paediatric exposure pathways. A theranostics treatment ward holding patients post-Lu-177-PSMA-617 dose for the radiation hold demands single-pass ventilation with HEPA-filtered exhaust because the patient is themselves a beta-gamma source for several days. A research nuclear facility supporting the Open Pool Australian Lightwater (OPAL) reactor operates under the highest tier of Australian nuclear regulation with the federal regulator ARPANSA continuously involved in design review and operational oversight.

This guide is the design reference SBKJ engineers in Box Hill North Victoria use when briefed by mechanical consultants, GMP project managers, radiation safety officers, validation engineers and fit-out contractors fabricating ductwork for Australian radiopharmaceutical, cyclotron PET, nuclear medicine, theranostics, synchrotron and research nuclear scopes. It walks through the regulatory framework, zone-by-zone HVAC specification, materials selection, the unusual hybrid pressure cascade that resolves the conflict between GMP product protection and ARPANSA radiation containment, the fabrication and commissioning sequence, and the verification protocol. It is not a substitute for a registered mechanical engineering design, an ARPANSA source licence consultation, a TGA radiopharmaceutical GMP licence consultation, a qualified Radiation Safety Officer or a qualified validation engineer.

The Australian regulatory and radiation safety stack

Nuclear and radiopharmaceutical HVAC in Australia sits within a tightly-layered stack of federal radiation legislation, harmonised international codes, GMP frameworks and Australian Standards. No single document gives the complete picture. The stack we work with on every project, in priority order, is set out below.

The ARPANS Act 1998 and the ARPANSA federal regulator

The Australian Radiation Protection and Nuclear Safety (ARPANS) Act 1998 establishes the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) as the federal regulator for radiation protection and nuclear safety. ARPANSA issues source licences and facility licences under the Act, maintains the National Directory for Radiation Protection (NDRP) and publishes the Radiation Protection Series (RPS) codes that bind the substantive engineering requirements. Every Australian radiopharmaceutical manufacturing facility, every cyclotron, every nuclear research facility and every theranostics treatment centre operates under at least one ARPANSA source licence. State radiation regulators operate alongside ARPANSA for non-Commonwealth licensees: NSW EPA Radiation Protection, EPA Victoria Radiation, Queensland Radiation Health, ACT Health Radiation, SA EPA Radiation Protection, WA Radiological Council, Tasmania Department of Health and the Northern Territory Department of Health. The state regulator typically holds the licence for state-government and private operators while ARPANSA holds Commonwealth licences directly.

ARPANSA RPS 8 Radiopharmaceutical Code of Practice

RPS 8 is the substantive ARPANSA code for radiopharmaceutical manufacturing, dispensing and clinical use. It sets the engineering requirements for radiopharmaceutical hot cells, glove boxes, dispensary cleanrooms, exhaust filtration including HEPA and activated carbon iodine traps, stack monitoring, radioactive waste management and the operator dose monitoring regime. RPS 8 is the document an ARPANSA inspector references when reviewing a radiopharmaceutical facility design or operation.

ARPANSA RPS 14 Radiation Protection in the Medical Industry

RPS 14 covers occupational and public exposure controls in nuclear medicine, PET, theranostics, radiology, fluoroscopy and radiation therapy. The HVAC implications run through the exhaust capture rates at dispensing stations, the patient holding room ventilation post-injection, the inpatient radiation isolation ward design for high-dose I-131 ablation patients and the operator dose monitoring framework.

ARPANSA RPS 5 Code for Safe Transport and Disposal of Radioactive Waste

RPS 5 covers the consignment, transport and disposal of radioactive waste including spent HEPA filters from radioactive exhaust paths, activated carbon iodine trap beds, contaminated PPE, decay-stored short-lived patient waste and the building decommissioning waste at end of facility life. The HVAC implication is that every component installed in the radioactive exhaust path will eventually become a radioactive waste consignment under RPS 5 — designing for ease of change-out, transport packaging and licensed disposal is part of the HVAC scope.

AS 2243.4 Safety in laboratories — Ionising radiations

AS 2243.4 is the foundation Australian Standard for laboratory radiation protection. It covers the engineering envelope for radioactive work areas: work surface materials and decontamination characteristics, local exhaust ventilation requirements, fume cupboard specification for radioactive work, HEPA filtration and stack monitoring requirements, shielded storage of radioactive sources, and the contamination control framework. AS 2243.4 sits as the technical reference behind the higher-level ARPANSA RPS codes.

AS/NZS 2243.3 Microbiological safety and AS/NZS 2243.10 LEV

AS/NZS 2243.3 covers physical containment level (PC) classification PC1 through PC4, aligned with the WHO Biosafety Levels BSL-1 through BSL-4. PC2 is the standard for QC microbiology associated with radiopharmaceutical manufacturing. PC3 is used for vaccine seed work and certain viral vector work intersecting with radiopharmaceutical chemistry. PC4 is reserved for the highest-containment work in Australia (the CSIRO Australian Animal Health Laboratory at Geelong, which is rare and outside the radiopharmaceutical scope). AS/NZS 2243.10 covers Local Exhaust Ventilation including fume cupboards, biological safety cabinets and downdraft tables — the design reference for the dispensing-bench exhaust at any radiopharmaceutical site.

AS/NZS 2982 Laboratory design, AS 2243.8 Fume cupboards

AS/NZS 2982 is the laboratory design and construction standard covering the building shell, finishes, services and the cleanroom design where applicable. AS 2243.8 covers fume cupboard performance — face velocity 0.5 m/s nominal, containment efficiency tested by tracer gas, the airflow alarm specification and the connection to the building exhaust system. Both apply to radiopharmaceutical dispensary and radiochemistry suites.

ICRP 103 dose limits and the ALARA principle

The International Commission on Radiological Protection (ICRP) Publication 103 (2007 recommendations, the current ICRP framework) sets the dose limits adopted by ARPANSA into Australian law: occupational effective dose 20 millisieverts per year averaged over five consecutive years with no single year exceeding 50 mSv; public effective dose 1 millisievert per year; equivalent dose limits for the lens of the eye, the skin and the extremities. ICRP 118 covers tissue reactions and threshold doses including the lens-of-the-eye threshold revision. The ALARA principle (As Low As Reasonably Achievable, economic and social factors considered) is the over-arching philosophy — the HVAC design holds doses well below the limits at every routine operating point.

TGA TGO 92 and PIC/S Guide to GMP PE 009

The Therapeutic Goods Order 92 (TGO 92) is the TGA's specific manufacturing standard for radiopharmaceuticals, adopted alongside the PIC/S Guide to GMP PE 009. TGA holds the manufacturing licence for any radiopharmaceutical sold for clinical use in Australia; ANSTO Camperdown, Cyclomedical Cyclopharm sites, Telix manufacturing, GenesisCare Theranostics and the hospital-based cyclotron PET facilities all operate under TGA radiopharmaceutical licences. The pharmaceutical GMP framework (covered separately in our companion guide on pharmaceutical, vaccine and API manufacturing GMP HVAC) applies in substance with radiopharmaceutical-specific overlays for the short shelf life, the radiation containment and the radioactive waste streams.

ICH Q7, Q8, Q9, Q10 and IAEA

ICH Q7 (API GMP), Q8 (pharmaceutical development), Q9 (quality risk management) and Q10 (pharmaceutical quality system) provide the international cross-cutting frameworks applicable to radiopharmaceutical manufacturing through the TGA and PIC/S framework. The International Atomic Energy Agency (IAEA) Safety Standards Series provides the international reference particularly for the nuclear research facilities and the safer broader context for radiopharmaceutical work. The IAEA Best Practice in Cyclotron Production (BCNM) document is the international engineering reference for cyclotron PET facilities.

USP <797> and USP <800>

USP <797> sterile compounding governs the aseptic handling of sterile pharmaceutical preparations including radiopharmaceutical dispensing and labelling. USP <800> hazardous drug handling overlays the chemotherapy and hazardous drug controls that crossover with radiopharmaceutical handling because Lu-177-PSMA-617, Y-90 microspheres and several other theranostic agents are both radioactive and toxic to handlers. The combination drives a Class II Type A2 or Type B2 biological safety cabinet at the dispensing position with HEPA-filtered exhaust to outdoor.

ASHRAE 170 healthcare HVAC and ISO 14644

ASHRAE 170 (Ventilation of Health Care Facilities) is the international engineering reference for healthcare HVAC and is widely cited in Australian briefs alongside AS 1668.2. ASHRAE 170 provides design ACH, pressure relationships, filtration and humidity tables for every space type in a healthcare facility including nuclear medicine, PET radiochemistry and radiopharmaceutical dispensary spaces. ISO 14644 cleanroom classification sets the particle count limits with the radiopharmaceutical dispensary critical zone at ISO Class 5, the surrounding cleanroom at ISO Class 7, and the support areas at ISO Class 8.

AS 1668.2, AS 4254 and AS 1530.4

AS 1668.2 is the National Construction Code's referenced mechanical ventilation standard, the legal floor for Australian building HVAC. AS 4254 sets ductwork construction and leakage classification with most radiopharmaceutical exhaust work falling into Class C (high pressure to 1,500 Pa). AS 1530.4 covers fire-rated construction including fire and smoke dampers at 250 degrees Celsius for 2 hours rating, integrated into the radiopharmaceutical building envelope with the same coordination challenges as any other healthcare fit-out.

AS/NZS 60079 hazardous area, Safe Work Australia WES

Radiopharmaceutical chemistry handles acetonitrile, dichloromethane, chloroform, ethanol, methanol and other solvents at gram-to-kilogram scale per batch. AS/NZS 60079 hazardous area classification applies where solvent inventory exceeds the AS 1940 thresholds. Safe Work Australia workplace exposure standards (WES) govern airborne chemical concentrations: acetonitrile 40 ppm STEL (the HPLC mobile phase and radiolabelling chemistry), ethanol 1,000 ppm 8-hour TWA, methanol 200 ppm, dichloromethane 50 ppm STEL, chloroform 10 ppm STEL, hydrogen fluoride 1.8 ppm STEL where F-18 production target HF capture chemistry operates, hydrogen cyanide 5 ppm STEL where Cu-64 chemistry runs, ozone 0.1 ppm STEL where UV and X-ray radiolysis produces ozone and NOx.

The radionuclide inventory and the airborne radioactivity limits

Every radiopharmaceutical, cyclotron PET, nuclear medicine and theranostics design starts from the radionuclide inventory: which isotopes the facility produces, dispenses or handles, at what activity, with what half-life and decay properties, and what the resulting derived air concentration (DAC) is at the routine operating point. The radionuclide inventory drives the HVAC.

Short-lived positron emitters (cyclotron PET tracers)

Fluorine-18 (F-18) has a 110-minute half-life and decays by positron emission, used predominantly as F-18 fluorodeoxyglucose (FDG) for glucose-metabolism PET imaging in oncology, neurology and cardiology — the dominant PET tracer in Australian clinical use. Carbon-11 (C-11) has a 20-minute half-life used for several research and selected clinical PET tracers. Nitrogen-13 (N-13) has a 10-minute half-life used for cardiac perfusion PET imaging with N-13 ammonia. Oxygen-15 (O-15) has a 2-minute half-life used for research blood-flow imaging with O-15 water. Gallium-68 (Ga-68) has a 68-minute half-life produced from a Ge-68/Ga-68 generator and used predominantly as Ga-68 PSMA-11 (Telix Pharmaceuticals Illuccix) for prostate cancer PET imaging and Ga-68 DOTATATE for neuroendocrine tumour PET imaging. Zirconium-89 (Zr-89) has a 3.3-day half-life used for antibody-imaging PET tracers including Telix Pharmaceuticals Zircaix.

Short-lived gamma emitters (nuclear medicine SPECT)

Technetium-99m (Tc-99m) has a 6-hour half-life and is the dominant gamma-emitting isotope used in approximately 80 percent of all nuclear medicine imaging procedures worldwide — bone scans, myocardial perfusion imaging, renal scans, lung perfusion and ventilation, gastrointestinal bleeding, and many oncology and inflammation imaging studies. Tc-99m is eluted from Mo-99 generators on-site at every nuclear medicine department in Australia, with ANSTO supplying the Mo-99 to the generator manufacturers and ANSTO Camperdown directly supplying generators to many Australian sites. Iodine-123 (I-123) has a 13-hour half-life used for thyroid imaging.

Beta-gamma emitters (theranostics therapy)

Lutetium-177 (Lu-177) has a 6.7-day half-life and decays by beta emission with a low-energy gamma allowing both therapeutic radiation dose delivery and post-therapy imaging in the same agent — the ideal theranostic radionuclide. Lu-177-PSMA-617 is the dominant theranostic agent for metastatic castration-resistant prostate cancer. Lu-177-DOTATATE is the dominant theranostic agent for neuroendocrine tumours. Lu-177 production occurs at ANSTO Lucas Heights via neutron activation of enriched Yb-176 or Lu-176 targets.

Yttrium-90 (Y-90) has a 64-hour half-life and decays by pure beta emission used for Y-90 microsphere selective internal radiation therapy (SIRT) of hepatic malignancies and Y-90 labelled antibody therapies. Iodine-131 (I-131) has an 8-day half-life and decays by beta emission with significant gamma emission, used for thyroid ablation therapy, I-131-MIBG therapy for neuroblastoma and certain neuroendocrine tumours, and historically for thyroid imaging (now displaced by I-123). Samarium-153 (Sm-153) has a 47-hour half-life used for bone metastases palliation. Holmium-166 (Ho-166) has a 27-hour half-life used in microsphere SIRT and selected research applications.

Long-lived radionuclides (research and industrial)

Tritium (H-3) has a 12.3-year half-life and decays by low-energy beta emission, used as radiolabelled water (HTO) in tracer studies and as a labelled component of biomolecules in research. The DAC for H-3 is approximately 7,400 Bq/m3, relatively high for a radionuclide because the beta is low-energy and the biological behaviour matches water with full body distribution rather than concentrated organ uptake.

Iodine-131 (I-131) DAC is approximately 33 Bq/m3 — one of the lowest DACs in the Australian radionuclide inventory because of the thyroid uptake risk, particularly in staff with paediatric exposure pathways. I-131 is the limiting design case for radioiodine exhaust at any Australian theranostics or nuclear medicine site handling I-131 capsules or solutions.

Air activation products and target gases

Cyclotron operation activates the air around the cyclotron vault and the target chamber, producing nitrogen-13 from N2 in air, oxygen-15 from O2 in air, and argon-41 from argon target gas or air contamination. The vault exhaust must allow decay through a delay tank or hold before release. Cyclotron and reactor target gases include hydrogen H2 (with hydrogen content held below 25 percent of the lower explosive limit in any chamber where H2 reduction chemistry runs), helium He and argon Ar as inert target gases with asphyxiation risk requiring oxygen depletion monitoring (the Safe Work Australia acceptable band is 19.5 to 23.5 percent O2), nitrogen N2 as target gas and as cryostat fill, and sulfur hexafluoride SF6 in synchrotron RF cavities and klystron HV switchgear as a heavy gas with asphyxiation risk and significant greenhouse gas impact (GWP 23,500).

ANSTO Lucas Heights — the OPAL reactor and the Mo-99 supply chain

The Australian Nuclear Science and Technology Organisation (ANSTO) operates Australia's only nuclear reactor — the Open Pool Australian Lightwater (OPAL) reactor at Lucas Heights in southern Sydney, NSW. OPAL is a 20 MW research reactor commissioned in 2007, replacing the legacy HIFAR reactor that operated on the same site from 1958 to 2007. OPAL is one of the most modern research reactors in the world, designed for high neutron flux, low-enriched uranium fuel and isotope production at scale.

The OPAL reactor hall and neutron beam guide hall

The OPAL reactor sits inside a heavily-shielded containment building with the reactor pool open at the top under a deep water column. The reactor hall provides operator access to the pool top during shutdown, instrumentation and beam line entry into the surrounding neutron beam guide hall, and the rabbit irradiation channels that move samples into and out of the reactor for activation. The neutron beam guide hall around the reactor provides experimental beam lines for neutron scattering science.

HVAC scope: the reactor hall is climate-controlled at 20 to 24 degrees Celsius with relative humidity 30 to 60 percent. Heavy concrete shielding (1.5 to 3 metres) and lead shielding around specific beam lines drive structural loads that the HVAC accommodates rather than competes with. Exhaust is HEPA H13/H14 filtered through bag-in bag-out housings with a delay path and continuous stack monitoring for radio-gas, iodine and particulate channels. The continuous air monitor (CAM) at the stack measures gamma activity by channel, iodine specific activity via a NaI(Tl) or HPGe detector tied to a specific I-131 energy window, and particulate via a fixed-filter sampler with auto-advance and gamma spectroscopy. Activated carbon iodine trap upstream of the stack captures any I-131 produced from reactor operations, sample irradiation activations or routine isotope production.

The ANSTO radiopharmaceutical manufacturing facility

Adjacent to OPAL and at the ANSTO Camperdown facility in Sydney, ANSTO operates the radiopharmaceutical manufacturing scope. Mo-99/Tc-99m generators are the largest single product, with ANSTO producing Mo-99 by neutron fission of low-enriched uranium targets at OPAL, separating the Mo-99 from the irradiated target in a heavily-shielded chemical processing line, and packaging Mo-99/Tc-99m generators for clinical use. ANSTO became the largest single source of Mo-99 globally following the closure of the Petten high-flux reactor in the Netherlands in late 2025 and currently supplies Mo-99 to the United States, Japan, Korea, Europe and the Asia-Pacific. The Mo-99 supply chain underpins approximately 80 percent of all nuclear medicine imaging procedures globally.

ANSTO additionally manufactures I-131 (capsules and solutions for thyroid ablation), Lu-177 for theranostics (supplied to Telix, GenesisCare and other theranostics providers), Sm-153 for bone metastases palliation, and various other research and clinical radionuclides.

HVAC scope at the radiopharmaceutical manufacturing facility: GMP cleanroom envelope at ISO Class 5 (EU GMP Grade A equivalent) inside lead-shielded hot cells for the radiochemical processing, dispensing and final packaging; ISO Class 7 (Grade B equivalent) background cleanroom with HEPA H14 supply at 40 to 60 ACH and Type 316L stainless steel ductwork; lead-shielded hot cells with 50 to 200 mm of Pb shielding plus lead glass viewing windows, internal HEPA exhaust through TEDA-impregnated activated carbon iodine traps for the I-131 line; biological safety cabinets Class II A2 for the sterility-related operations; remote manipulators and master-slave handling at every position where radiation field requires it. Stack discharge through delay tank, continuous air monitor and vertical discharge stack with continuous radiation monitoring tied to the facility Radiation Safety Plan.

ANSTO Camperdown

ANSTO Camperdown is the Sydney-based radiopharmaceutical manufacturing site operating alongside the Lucas Heights primary facility. Camperdown produces Tc-99m generators for distribution to nuclear medicine departments across Australia and the Asia-Pacific, with the Mo-99 supplied from Lucas Heights. The Camperdown HVAC scope is the GMP radiopharmaceutical manufacturing envelope — cleanrooms, hot cells, exhaust filtration, stack monitoring — without the reactor hall scope held at Lucas Heights.

The Australian Synchrotron — storage ring building HVAC

The Australian Synchrotron at Clayton VIC, operated by ANSTO since 2016, is a third-generation 3 GeV electron storage ring with 216 metre circumference. The facility comprises a linear accelerator (linac) injecting electrons into a booster synchrotron ring that accelerates them to 3 GeV, the storage ring that maintains the electrons at energy with replenishment from the linac and booster, and 32 active beam lines around the storage ring delivering synchrotron radiation (X-rays from infrared through hard X-ray) into experimental endstations.

The storage ring building climate control

The storage ring tunnel, the experimental hall housing the beam lines and the support facilities are climate-controlled at 20 to 22 degrees Celsius at plus or minus 0.5 Kelvin stability and 35 to 45 percent relative humidity at plus or minus 5 percent. The thermal stability requirement is driven by the precision optics, the diffraction-limited beam lines (MX1 and MX2 macromolecular crystallography, in particular, demand sub-micron sample positioning that thermal drift compromises), and the vacuum chamber stability. The storage ring components include RF cavities (typically superconducting at 4 K, with cryogenic helium cooling and SF6-insulated transmission lines), klystrons (high-power microwave amplifiers driving the RF cavities), magnets (bending dipoles, focusing quadrupoles, sextupoles for chromaticity correction), vacuum chambers (ultra-high vacuum at 10E-9 to 10E-10 mbar) and the beam diagnostics instrumentation.

Radiation shielding and air activation

The storage ring tunnel is concrete-shielded at 1 to 2 metres thickness to attenuate the synchrotron radiation and the beam-loss bremsstrahlung. The supply and exhaust pass through labyrinthine penetrations to prevent radiation streaming through the duct paths. Air activation in the storage ring tunnel produces nitrogen-13 (N-13 from N2) and oxygen-15 (O-15 from O2) by photonuclear reactions at the highest electron energies and during beam loss events. The exhaust HEPA H13 filters particulate; the short half-life of N-13 (10 minutes) and O-15 (2 minutes) means a short delay path on the exhaust allows substantial decay before release. Continuous stack monitoring measures the residual activity.

SF6 and oxygen depletion monitoring

Sulfur hexafluoride (SF6) is the standard insulating gas in high-voltage switchgear (the synchrotron has substantial HV electrical infrastructure) and is used in some RF cavity insulation, klystron HV connections and the electron gun HV interfaces. SF6 is a heavy gas (density 6.2 kg/m3 versus air at 1.2 kg/m3) that pools in pits, sub-floor voids and low-lying spaces; SF6 is also a potent greenhouse gas (GWP 23,500) and an asphyxiation risk because it displaces air. The HVAC includes SF6 leak detection at the floor in any area where SF6 equipment operates, with extraction at the low point to remove any leaked SF6 from the workspace. Oxygen depletion monitoring at breathing height alarms at 19.5 percent (the Safe Work Australia minimum safe O2 concentration). Cryogenic helium handling for the superconducting RF cavities introduces nitrogen displacement risk during cool-down or cryogen vent events, also addressed by oxygen depletion monitoring.

Beam line experimental halls

The 32 active beam lines around the Australian Synchrotron storage ring run experimental work in macromolecular crystallography (MX1 and MX2 for protein structure determination), imaging and medical beam line (IMBL for biomedical imaging), infrared spectroscopy (IR), small-angle scattering (SAXS), powder diffraction (PD), high-energy diffraction, soft X-ray spectroscopy, and the broader array of synchrotron science. Each beam line has its own experimental hall with sample environments ranging from ambient temperature solution samples to cryogenic crystal samples to high-pressure cells to controlled-atmosphere environments. The HVAC at the experimental hall provides operator comfort conditions with the sample environment HVAC being a specialist scope often delivered by the sample-environment vendor (Oxford Cryosystems, MMR Technologies and equivalents). Type 316L stainless steel ductwork is the standard for the experimental halls where chemical exposure from beam line operations may occur; Type 304 is acceptable in the conventional administrative and plant areas.

Cyclotron PET production facilities — Cyclomedical Cyclopharm and the hospital cyclotrons

A medical cyclotron is a particle accelerator producing positron-emitting isotopes by proton bombardment of stable target materials. Australian cyclotron operators include Cyclomedical Cyclopharm (ASX:CYC) with sites across Sydney, Melbourne, Brisbane, Adelaide, Perth and Canberra; ANSTO Camperdown; hospital-based cyclotrons at Auburn Hospital (NSW), Royal Brisbane and Women's Hospital, Royal Perth Hospital, Royal Adelaide Hospital, Royal Melbourne Hospital, Peter MacCallum Cancer Centre and Austin Health. The cyclotron at each site produces F-18 FDG for same-day clinical PET imaging and increasingly Ga-68 (from generator elution rather than direct cyclotron production at most sites) and Zr-89.

The cyclotron vault

The cyclotron at a clinical PET site is typically an IBA Cyclone, GE TR-19 or TR-24, Siemens Eclipse, Sumitomo or equivalent unit at 10 to 30 MeV proton beam energy. The cyclotron vault is heavily shielded: 1.5 to 2.5 metres of high-density concrete (typically 3,500 to 4,500 kg/m3 density using barite or magnetite aggregates) plus borated polyethylene for neutron attenuation. The vault is operator-accessible only during shutdown with the cyclotron beam off and adequate cool-down time for activation products to decay. Routine operation is fully remote from the control room.

HVAC at the cyclotron vault: dedicated low-rate ventilation at 4 to 6 ACH supplied through labyrinthine penetrations in the shielding to prevent direct radiation paths through the ductwork. The supply air enters the vault, passes the cyclotron and target locations, and exhausts through the labyrinthine exhaust penetration. All exhaust passes through HEPA H14 filtration and a delay tank sized to allow N-13 (10 min), O-15 (2 min) and Ar-41 (110 min) to decay below release limits, then through continuous stack monitoring (gamma channels by energy, iodine channel for I-131 if produced, particulate channel) and the vertical discharge stack at minimum 3 metres above roof, minimum 12 m/s discharge velocity.

The radiochemistry hot cell line

The cyclotron-produced isotope is delivered to the radiochemistry hot cell line via shielded transfer lines (typically tubes through the building penetrations from the cyclotron vault to the radiochemistry suite). Each radiochemistry module is a lead-shielded hot cell at 50 to 100 mm of Pb on the walls plus lead glass viewing window. Inside the hot cell, a fully automated synthesis module (Eckert and Ziegler, Trasis, GE FastLab, IBA Synthera and equivalents) carries out the radiolabelling chemistry — F-18 to F-18 FDG, Ga-68 to Ga-68 PSMA-11, Ga-68 to Ga-68 DOTATATE, Lu-177 to Lu-177-PSMA-617 and so on — with the operator interacting via a control screen from outside the lead shielding.

HVAC at the radiochemistry hot cell line: the hot cells sit inside a Grade C cleanroom envelope (ISO 14644 Class 8 in operation, EU GMP Grade C equivalent) with HEPA H14 supply at 20 to 40 ACH from the cleanroom ceiling. The hot cell internal volume is maintained at negative pressure relative to the surrounding cleanroom (typically -10 to -30 Pa) by a dedicated hot cell exhaust system independent of the cleanroom return. The hot cell exhaust ducts to outdoor through a HEPA H14 prefilter, an activated carbon iodine trap (where I-131 chemistry runs), a delay tank and the stack monitor. This is the hybrid pressure cascade that is the unusual feature of radiopharmaceutical design: the cleanroom is positive pressure for GMP product protection while the hot cell within it is negative pressure for ARPANSA radiation containment.

The radiopharmaceutical dispensary

Downstream of the radiochemistry hot cells, the formulated radiopharmaceutical is dispensed into the individual patient unit doses or shipped to the using clinical site. The dispensary is at ISO Class 5 (EU GMP Grade A equivalent) at the critical dispensing point inside a lead-shielded biosafety cabinet or hot cell with the same Grade A/B/C pressure cascade as conventional aseptic fill-finish overlaid with the negative-pressure radiation containment at the dispensing point. Shielded vial handling, remote sample changers and autosamplers at the dispensing position keep operator doses ALARA.

Radiopharmaceutical hot cell and glove box duct design

The radiopharmaceutical hot cell or glove box is the single most engineering-demanding item in the entire facility HVAC scope. The hot cell contains the radioactive process at production-relevant activity, provides the lead and lead-glass shielding for operator dose control, allows remote handling by master-slave manipulators or fully-automated modules, and contains the entire exhaust path that captures any released radionuclide, particulate or vapour.

Hot cell shielding and the duct interface

The hot cell shielding is typically 50 to 200 mm of lead (Pb) on the walls and the viewing window, with the wall lead either as solid sheet or as lead-loaded panels and the viewing window as multi-layer lead glass (typically 4 to 12 layers depending on the radiation field). The hot cell interior is fibreglass-reinforced plastic (FRP) for easy decontamination, with stainless steel work surfaces at the critical positions. The hot cell exhaust penetration through the lead shielding uses a stepped labyrinthine path that prevents radiation streaming — a straight duct penetration would allow radiation to escape through the duct path even when the duct itself attenuates negligibly.

The duct interface plate at the hot cell exhaust is a Type 316L stainless steel plate fabricated to dimensional tolerance, welded to the hot cell envelope (or bolted with gasketed flanges where shielding installation requires post-fabrication assembly), and providing the connection point for the downstream Type 316L stainless steel exhaust ductwork. SBKJ fabricates the interface plate and the downstream stainless ductwork; the lead-shielded section through the shielding wall (Pb-lined duct at 6 to 50 mm of lead lining) sits outside the SBKJ scope and is supplied separately by specialist nuclear shielding fabricators with the integration at the interface plate.

HEPA H14 BIBO filter housing

Immediately downstream of the hot cell exhaust collar, the HEPA H14 bag-in bag-out (BIBO) filter housing captures particulate and aerosol-bound radionuclides. The BIBO housing is a fully welded Type 316L stainless steel pressure vessel accepting standard filter modules (typically 610 by 610 by 292 millimetre or 610 by 610 by 150 millimetre) with gel seal frames at the filter mating face. The bag-out provisions allow filter change-out under containment: a continuous PVC bag is sealed to the housing change-out port, the spent filter is pulled into the bag, the bag is sealed and cut, and a new filter is inserted from a fresh bag — the operator never contacts the contaminated filter directly. The filter change-out is a radiation-exposure event under the facility Radiation Safety Plan with the spent filter consigned as radioactive waste under ARPANSA RPS 5.

Activated carbon iodine trap

For any exhaust line handling I-131 (radioiodine, the dominant beta-gamma emitter requiring vapour-phase capture), the activated carbon iodine trap is the load-bearing engineering item. The trap is a fully welded Type 316L stainless steel housing accepting a packed bed of impregnated activated carbon at typical bed depth 50 to 150 mm and face velocity 0.25 to 0.5 m/s. The carbon impregnation is the key specification: TEDA (triethylenediamine) and potassium iodide (KI) impregnation provides high efficiency for elemental iodine I2 (the dominant chemical form of vaporised iodine), methyl iodide CH3I (the dominant organic iodide form) and inorganic iodide I-. Efficiency targets are typically 99.9 percent or better for elemental I2 and 95 percent or better for methyl iodide, verified by annual challenge testing per ASTM D3803 with methyl iodide tracer.

Triple-bed configurations are common at higher-activity sites: a first bed captures the bulk of the iodine, the second bed provides redundancy, and the third bed provides verification by activity assay. Bed change-out is a controlled radiation-exposure event with the spent carbon bagged, drummed and consigned as radioactive waste under ARPANSA RPS 5. The change-out interval depends on the throughput, typically 6 to 24 months at clinical sites and shorter at high-throughput manufacturing sites.

Delay tank and stack monitor

Downstream of the iodine trap, a delay tank sized for the longest-lived produced isotope allows decay to release-acceptable activity before stack discharge. For a cyclotron PET site producing F-18 (110 min), the delay tank residence time is typically 30 to 60 minutes at minimum exhaust flow allowing approximately 1 to 2 half-lives of decay. For a Mo-99 manufacturing site, the delay tank is larger to accommodate the longer half-life. The delay tank is a fully welded Type 316L stainless steel cylindrical vessel produced by the SBKJ SBFB-1500 spiral former and SBSF-1525 stitchwelder.

Stack monitoring at the discharge throat measures gamma activity by energy channel (allowing identification of the released isotopes), specific iodine activity via a separate detector channel tied to the I-131 364 keV energy line, and particulate activity via a fixed-filter sampler with auto-advance and offline gamma spectroscopy. Release-limit alarms tie to the facility Radiation Safety Plan with the ARPANSA RPS 5 limits as the regulatory ceiling.

The radiopharmaceutical dispensary cleanroom — pressure cascade design

The radiopharmaceutical dispensary is the cleanroom suite that prepares finished radiopharmaceutical doses from the bulk radiopharmaceutical produced upstream. The dispensary is at ISO Class 5 at the critical dispensing point with ISO Class 7 background and ISO Class 8 support, identical in particle count terms to a conventional aseptic fill-finish suite. The unique feature is the hybrid pressure cascade that resolves the conflict between GMP product-protection logic (positive cleanroom) and ARPANSA radiation-containment logic (negative hot cell).

The hybrid pressure cascade

A conventional GMP aseptic fill-finish suite holds Grade A at positive pressure to Grade B at positive pressure to Grade C at positive pressure to corridor — the airflow direction from cleanest to less clean keeps contaminant out of the critical product zone. A conventional BSL-3 vaccine manufacturing suite holds the working room at negative pressure to corridor — the airflow direction from outside to inside keeps the biological hazard contained. A radiopharmaceutical dispensary handling Lu-177-PSMA-617 must do both: the cleanroom around the dispensing position is positive to corridor (GMP product protection) while the lead-shielded dispensing hot cell or biosafety cabinet within the cleanroom is negative to the cleanroom (ARPANSA radiation containment).

The resolution: the cleanroom HVAC supplies the cleanroom through HEPA H14 terminal filters at 40 to 60 ACH for the Grade B background, maintaining the cleanroom at +10 Pa to corridor; the hot cell HVAC is independent, with the hot cell exhaust drawing air from the surrounding cleanroom into the hot cell at typically -10 to -30 Pa to the cleanroom and exhausting through the HEPA H14 / carbon trap / delay tank / stack monitor path described above. The cleanroom return is independent of the hot cell exhaust and remains in the cleanroom recirculation loop. The result: the cleanroom is positive to corridor for GMP, the hot cell is negative to cleanroom for radiation containment, and the airflow direction at the operator interface (the glove ports or the open work face) is always into the hot cell, never out.

Biological safety cabinet at the dispensing position

Many radiopharmaceutical dispensing positions use a Class II Type A2 or Type B2 biological safety cabinet (BSC) rather than a fully-shielded hot cell. The BSC provides the local Grade A unidirectional flow at the dispensing position, the HEPA H14 filtration of supply and exhaust, and the operator protection through the front aerofoil and the inflow at the work-zone opening. A Type A2 BSC recirculates 70 percent of the air through HEPA inside the cabinet and exhausts 30 percent to outdoor through HEPA — appropriate where the radionuclide is non-volatile and the chemistry is benign. A Type B2 BSC exhausts 100 percent to outdoor through HEPA — required where the radionuclide is volatile (I-131) or the chemistry is volatile (volatile solvents at the dispensing point).

For I-131 dispensing, a Type B2 BSC with downstream activated carbon iodine trap is the standard configuration. For Lu-177 dispensing where the lead shielding requirement is heavy, a fully lead-shielded hot cell with internal HEPA exhaust is the standard. For Tc-99m generator elution and dispensing in nuclear medicine departments, a lead-shielded dispensing station with local exhaust capture is the standard.

Shielded vial handling and remote dispensing

Inside the BSC or hot cell, shielded vial pots (typically 6 to 25 mm of lead around the vial), remote dispensing tools and automated sample changers keep the operator hand dose below the ICRP 118 extremity dose limit of 500 mSv per year. Lu-177 at clinical activity is gloved-hand dosimetry-limited; the engineering control is automation rather than additional shielding. The dispensary HVAC supports the automation hardware (positioning systems, robotic dispensers, sample changers) with adequate make-up air for the dispensing pump exhaust and stable cleanroom conditions for the automation positioning accuracy.

Theranostics treatment suites — GenesisCare, Peter Mac, Royal hospitals

Theranostics combines a diagnostic imaging radiopharmaceutical with a therapeutic radiopharmaceutical targeted to the same biological pathway. The diagnostic agent confirms target expression in the patient and quantifies the dose; the therapeutic agent delivers the radiation dose. The leading clinical theranostic pairs in Australia 2026 are Ga-68-PSMA-11 imaging followed by Lu-177-PSMA-617 therapy for metastatic castration-resistant prostate cancer; Ga-68-DOTATATE imaging followed by Lu-177-DOTATATE therapy for neuroendocrine tumours; Y-90 microsphere selective internal radiation therapy for hepatic malignancies. The clinical workflow is: PET-CT or PET-MRI imaging on day 1 to confirm target and quantify dose, therapy infusion on day 2 to 7 depending on scheduling, post-therapy imaging at day 1 to 7 post-therapy for dosimetry, repeat treatment cycle every 6 to 8 weeks for the full therapy course (typically 4 to 6 cycles).

GenesisCare Theranostics

GenesisCare Theranostics is Australia's largest cancer theranostics provider with treatment centres across Sydney, Melbourne, Brisbane, Adelaide, Perth, Canberra and the Gold Coast. The GenesisCare theranostics service spans the imaging diagnosis (Ga-68 PET-CT, F-18 PET-CT), the therapy administration (Lu-177-PSMA-617 and Lu-177-DOTATATE infusion), and the post-therapy imaging and dosimetry. Each treatment site requires a radiopharmaceutical dispensary preparing the patient dose from bulk radiopharmaceutical (sourced from ANSTO for Lu-177 and from Telix or Cyclotek for Ga-68), an injection room with shielded chair and dedicated exhaust where the patient receives the infusion, a patient holding area for the post-injection radiation hold, and the imaging suite for the post-therapy scan.

Peter MacCallum Cancer Centre, Royal Brisbane and Women's, Royal Adelaide, Royal Perth, St Vincent's Sydney

The major Australian cancer centres operating theranostics services include Peter MacCallum Cancer Centre in Melbourne, the Royal Brisbane and Women's Hospital, Royal Adelaide Hospital, Royal Perth Hospital, St Vincent's Sydney (with the PETMI cyclotron) and Westmead Hospital. Each operates a nuclear medicine and theranostics service with the HVAC scope spanning radiopharmaceutical dispensary, injection rooms, patient holding, PET-CT and PET-MRI imaging suites, and the inpatient radiation isolation ward for I-131 high-dose ablation patients.

Inpatient radiation isolation ward

I-131 high-dose thyroid ablation therapy (typically 3,700 to 7,400 MBq administered activity) requires the patient to be hospitalised in a radiation isolation ward room for typically 3 to 5 days until the body activity falls below the ARPANSA discharge criteria (typically 600 MBq retained activity). The ward room has dedicated single-pass HVAC with HEPA H14 exhaust through an activated carbon iodine trap to a separate dedicated stack, waste-water hold tanks for the patient's urinary and faecal excreta which retain significant activity, lead shielding in the walls and ceiling to protect adjacent staff and other patients, and a remote patient monitoring system that minimises staff entry to the room during the high-activity period.

HVAC scope: the ward room is at -10 to -15 Pa to the corridor (negative pressure for radiation containment), 6 to 8 ACH single-pass HEPA H14 supply with no recirculation, HEPA H14 exhaust through activated carbon iodine trap to dedicated stack monitor and vertical discharge. Type 316L stainless steel ductwork throughout because the chronic I-131 exposure compromises galvanised and the cleaning chemistry (typically peracetic acid or chlorhexidine) attacks Type 304. The waste-water hold tanks (typically two tanks operated alternately, sized for two-week patient activity hold to allow I-131 decay) are outside the HVAC scope but the ventilation of the hold tank room is a HVAC item with hydrogen sulfide and ammonia monitoring overlaid.

PET-CT and PET-MRI imaging suites

Positron emission tomography (PET) imaging is the dominant clinical use of cyclotron-produced isotopes in Australia. PET-CT combines PET with computed tomography for anatomical correlation in the same machine; PET-MRI combines PET with magnetic resonance imaging for higher soft-tissue contrast. PET-CT is the more common modality in Australian clinical use; PET-MRI is operated at Royal Adelaide Hospital, Royal Brisbane and Women's, St Vincent's Sydney and a small number of other sites.

The PET-CT imaging suite

The PET-CT imaging suite comprises the scanner room itself, an adjacent uptake room (where the patient waits during the 60-minute F-18 FDG uptake interval), a hot lab where the patient dose is prepared from the bulk F-18 FDG delivered from the cyclotron PET production site, an injection room where the patient receives the F-18 FDG injection, and the control room for the technologist. The radiation safety design requires lead shielding (typically 5 to 10 mm of Pb in the walls of the scanner room and uptake room, with shielded windows for technologist viewing) and HVAC that supports the patient flow.

HVAC scope: 6 to 8 ACH supply at ASHRAE 170 nuclear medicine conditions (21 to 24 degrees Celsius, RH 30 to 60 percent), HEPA H13 supply for the imaging suite (HEPA H14 for the hot lab where F-18 is dispensed), local exhaust capture at the dose preparation bench through HEPA H14 to dedicated stack, exhaust from the patient uptake room and injection room to outdoor through HEPA without recirculation (the patient is a transient radiation source and the exhaust prevents room-to-room air transfer). Type 316L stainless steel ductwork at the hot lab and dose preparation areas; Type 304 acceptable at the imaging suite where chemical exposure is low.

The PET-MRI imaging suite

PET-MRI adds the magnetic resonance imaging scanner to the PET scope. The MRI introduces additional HVAC scope: the magnet hall is held at controlled temperature (typically 19 to 21 degrees Celsius) with non-magnetic HVAC equipment (no steel diffusers within the 5 Gauss line, no steel ductwork within the magnet bore proximity), the quench vent path that exhausts cryogenic helium and nitrogen in the event of magnet quench, and the RF shielding integration where the duct penetrations through the RF cage are detuned to prevent RF leakage. The HVAC ductwork in the magnet hall is Type 316L stainless steel (non-magnetic) for the quench vent path and inside the magnet's strong-field region; standard ductwork in lower field areas. AS 1668.2 sets the baseline; ASHRAE 170 provides the healthcare overlay; the specific MRI safety requirements come from the scanner vendor and the IEC 60601 series for medical electrical equipment.

Nuclear medicine departments — the I-MED Radiology and hospital network

Nuclear medicine departments are the broader healthcare scope that uses Tc-99m for the dominant gamma imaging studies (bone, cardiac, renal, lung, GI, oncology imaging) and I-131 for thyroid imaging and ablation. The departments operate across the major Australian radiology providers: I-MED Radiology (Sydney, Melbourne, Brisbane, Perth, Adelaide and nationwide), Lake Imaging, Lumus Imaging, Capital Radiology, and the hospital nuclear medicine departments at every major teaching hospital.

The radiopharmacy hot lab

Each nuclear medicine department operates a radiopharmacy hot lab where Tc-99m is eluted from Mo-99 generators (supplied by ANSTO) and labelled to the various Tc-99m radiopharmaceutical kits (Tc-99m MDP for bone, Tc-99m MAA for lung, Tc-99m sestamibi for cardiac, Tc-99m DTPA for renal, Tc-99m DMSA for renal cortical and many others). The hot lab is at ISO Class 7 background with the dispensing position at ISO Class 5 inside a Class II Type A2 BSC or a lead-shielded laminar flow hot cell. The exhaust runs through HEPA H14 to a stack with continuous monitoring. The hot lab also handles the limited I-131 capsules and solutions used in the department, with the I-131 dispensing through a Type B2 BSC or hot cell with activated carbon iodine trap on the exhaust.

The patient injection and uptake suite

Patients receive the radiopharmaceutical injection in a dedicated injection room (lead-shielded, dedicated exhaust to outdoor) and wait in an uptake room (also lead-shielded with dedicated exhaust) for the 30 to 90 minute uptake interval before imaging. The injection rooms and uptake rooms are typically -5 to -10 Pa to the corridor (slight negative for radiation containment) with single-pass HEPA-filtered exhaust.

Universities with nuclear, synchrotron and accelerator facilities

Australian universities operating nuclear, synchrotron-related and accelerator infrastructure include the Australian National University (ANU) at Canberra with the Heavy Ion Accelerator Facility (HIAF), the University of Sydney (USyd) with multiple physics and chemistry accelerator capabilities, the University of Melbourne with the Bio21 Molecular Science and Biotechnology Institute, Monash University at Clayton VIC (host of the Australian Synchrotron campus), the University of Queensland (UQ) Brisbane, UNSW Sydney, and the University of Western Australia (UWA) Perth.

The HVAC scopes at these university facilities range from research nuclear laboratories at PC2 with AS 2243.4 radiation handling provisions, through accelerator vault ventilation with HEPA filtration and stack monitoring, to large-scale synchrotron building HVAC at Monash. The general engineering pattern follows the radiopharmaceutical and synchrotron pattern set out above with the smaller scale and the lower routine activities allowing some simplification.

CSIRO, Pawsey, SKA and ASKAP

The Commonwealth Scientific and Industrial Research Organisation (CSIRO) operates major scientific infrastructure across Australia including the Lindfield NSW campus, Black Mountain ACT, Newcastle NSW, Clayton VIC and Adelaide SA. CSIRO scientific facilities include radio astronomy infrastructure, laboratory chemistry and biology facilities, and selected accelerator and radiation work.

The Pawsey Supercomputing Centre in Perth supports the data infrastructure for the Australian SKA Pathfinder (ASKAP) at the Murchison Radio-astronomy Observatory (MRO) in the Mid-West Murchison WA radio-quiet zone. The Square Kilometre Array (SKA) is the international collaboration building the world's largest radio telescope with the Australian component at the MRO and the South African component at the Karoo. The HVAC scope at these astronomy and computing facilities focuses on electronics cooling, environmental stability for the radio-frequency-sensitive equipment, and standard occupancy ventilation rather than the radiation handling that dominates the ANSTO and radiopharmaceutical scopes.

Operator network and industry bodies

Australia's radiopharmaceutical, nuclear medicine and theranostics network comprises a tight set of operators and industry bodies.

Telix Pharmaceuticals (ASX:TLX)

Telix Pharmaceuticals is Australia's largest theranostic radiopharmaceutical company with global manufacturing and clinical reach. Telix's flagship products include Illuccix (Ga-68 PSMA-11 for prostate cancer PET imaging), Pixclara (F-18 brain PET tracer), Zircaix (Zr-89 prostate cancer antibody imaging) and a development pipeline spanning theranostic radioligand therapies. Telix operates radiopharmaceutical manufacturing capability in Australia, the US and Europe with cyclotron and hot cell line capacity to support the clinical demand.

Cyclomedical Cyclopharm (ASX:CYC)

Cyclomedical Cyclopharm operates cyclotron PET production sites across Sydney, Melbourne, Brisbane, Adelaide, Perth and Canberra producing F-18 FDG for same-day clinical PET imaging supply to the broader nuclear medicine and PET imaging network. Cyclomedical Cyclopharm holds the TGA radiopharmaceutical manufacturing licence for each production site and operates under the ARPANSA RPS 8 framework.

GenesisCare

GenesisCare is Australia's largest provider of cancer therapy services with operations spanning radiotherapy, theranostics, medical oncology and chemotherapy. GenesisCare Theranostics centres deliver Lu-177-PSMA-617 prostate cancer therapy, Lu-177-DOTATATE neuroendocrine tumour therapy and the associated imaging and follow-up across Sydney, Melbourne, Brisbane, Adelaide, Perth, Canberra and the Gold Coast.

ANSTO and ANSTO Health

The Australian Nuclear Science and Technology Organisation (ANSTO) is the Commonwealth Government-owned operator of the OPAL reactor, the Australian Synchrotron and the broader Australian nuclear science infrastructure. ANSTO Health is the commercial radiopharmaceutical manufacturing arm of ANSTO supplying Mo-99/Tc-99m generators, I-131, Lu-177, Sm-153 and other clinical radionuclides to the Australian and international markets. ANSTO became the largest single Mo-99 source globally following the Petten reactor closure in late 2025 and the supply chain underpins approximately 80 percent of all nuclear medicine imaging worldwide.

Industry bodies

The Australian Institute of Nuclear Science and Engineering (AINSE) connects Australian universities to ANSTO. The Australian Radioisotopes Industries (ARI) is the broader industry body. ARPANSA is the federal regulator. The Australian and New Zealand Society of Nuclear Medicine (ANZSNM) is the clinical professional body. The Australian Association of Nuclear Medicine Specialists (AANMS) covers the specialist clinical workforce. The Australasian Radiopharmaceutical Trials Network covers the clinical research consortium. The International Atomic Energy Agency (IAEA) provides the international framework and the International Commission on Radiological Protection (ICRP) provides the dose-limit science underpinning the ARPANSA codes.

Ductwork material selection — the radiopharmaceutical decision matrix

The material selection in a radiopharmaceutical or nuclear medicine facility carries the combined burden of GMP cleanroom (Type 316L stainless required in classified zones), radioactive exhaust (Type 316L stainless required for chloride and acid resistance plus chronic radionuclide deposition), and conventional support spaces (galvanised acceptable). The radiopharmaceutical decision matrix concentrates Type 316L stainless in the production envelope, uses Type 304 in less-critical support, and uses galvanised in unclassified spaces.

Type 316L stainless — mandatory zones: (1) all radiopharmaceutical cleanroom supply, return and exhaust ductwork; (2) hot cell exhaust upstream and downstream of the HEPA H14 BIBO housing; (3) activated carbon iodine trap housing and all associated ductwork; (4) delay tank and stack discharge ductwork; (5) BSC exhaust to outdoor; (6) inpatient radiation isolation ward room HVAC; (7) PET-CT hot lab exhaust; (8) cyclotron vault exhaust through the labyrinthine penetrations and downstream to the stack; (9) ANSTO reactor hall exhaust; (10) synchrotron experimental hall ductwork where chemical exposure may occur; (11) any duct passing chloramine, peracetic acid, hydrogen peroxide, glutaraldehyde, ethanol, acetonitrile, methanol, dichloromethane, chloroform or other radiopharmaceutical chemistry solvents at exposure-relevant concentrations.

Type 304 stainless — recommended zones: (1) PET-CT imaging suite supply where chemical exposure is low; (2) PET-CT uptake and injection room supply; (3) nuclear medicine department supply outside the hot lab; (4) administrative areas adjacent to radiopharmaceutical work where the airflow direction means any contamination is unidirectional outward.

Galvanised (G90 minimum) — acceptable zones: (1) unclassified corridors; (2) warehouse spaces holding non-radioactive consumables; (3) plant rooms outside the radiation envelope; (4) administrative offices; (5) staff amenities; (6) the cyclotron vault internal ventilation paths inside the shielded vault (the shielded environment excludes the conventional cleanroom chemistries and the conventional radiopharmaceutical exhaust loadings); (7) Australian Synchrotron support buildings outside the storage ring tunnel and beam lines.

Heavy-gauge fire-rated stainless at 250 degrees Celsius for 2 hours (AS 1530.4) for any fire-compartmented penetration through the radiopharmaceutical envelope, fabricated with the SBKJ SBSF-1525 stitchwelder with full TIG seam welding.

Lead-shielded duct sections at 6 to 50 mm of Pb lining outside the SBKJ scope. Specialist nuclear shielding fabricators supply the Pb-lined sections with the integration at the SBKJ-fabricated stainless interface plate via gasketed flange joints. The SBKJ engineering team coordinates with the lead shielding fabricator throughout the project lifecycle.

Oxygen-free copper duct for synchrotron RF cavity and electron-gun applications is fabricated by manual stitchwelding outside the SBKJ auto-line scope. The SBKJ engineering team can advise on the specification but the fabrication is by specialist accelerator vendors.

Coil traceability and TGA / ARPANSA audit. Any stainless duct section installed in an Australian TGA-licensed radiopharmaceutical or ARPANSA-licensed nuclear facility must be mill-certified with the heat number traceable to the finished duct section. The SBAL-V configured with coil release tracking captures the heat number at line entry and ties it to the production batch, satisfying TGA radiopharmaceutical audit, ARPANSA inspection and FDA pre-approval inspection without site-fabrication reconciliation.

HEPA H14 strategy, BIBO housing and the activated carbon trap chain

The radiopharmaceutical exhaust filtration chain is the most engineering-intensive element of the entire HVAC scope. The chain runs from the hot cell exhaust collar through HEPA prefilter, BIBO H14, activated carbon iodine trap (where I-131 is present), delay tank, stack monitor and vertical discharge stack.

HEPA prefilter and BIBO H14

The HEPA prefilter (typically a F9 or H10 grade) extends the life of the downstream H14 by capturing the larger particulate. The bag-in bag-out (BIBO) H14 housing is the change-out interface where the spent filter is removed under containment via a continuous PVC bag. The BIBO housing specification: fully welded Type 316L stainless steel pressure vessel, leak-tested at 1.5 times maximum operating static, accepting standard 610 by 610 millimetre filter modules with gel seal frames, upstream test port for IEST-RP-CC034 PAO challenge, downstream port for photometer scan, bag-out port with 50 to 100 micron PVC change-out bag.

Activated carbon iodine trap chain

The activated carbon iodine trap is sized for the credible I-131 release and the operational change-out interval. Bed depth 50 to 150 mm at face velocity 0.25 to 0.5 m/s. Carbon impregnation with TEDA (triethylenediamine, 2 to 5 percent by weight) and potassium iodide (KI, 1 to 5 percent by weight). Triple-bed redundancy at high-throughput sites. Annual challenge testing per ASTM D3803 with methyl iodide tracer.

Delay tank and stack discharge

The delay tank residence time is sized for the longest-lived produced isotope half-life. For a cyclotron PET site producing F-18 (110 min), 30 to 60 minutes residence at minimum flow. For a Mo-99 manufacturing site, longer. For a Lu-177 theranostics dispensary, the longer Lu-177 half-life (6.7 days) means the delay tank cannot meaningfully decay Lu-177 itself but does decay the short-lived activation products. Stack discharge is vertical, minimum 3 metres above roof, minimum 8 metres horizontal from any outdoor air intake, minimum 12 m/s discharge velocity. Continuous stack monitor with gamma channels, specific iodine channel and particulate channel feeding the BMS and the Radiation Safety Plan.

BMS integration with the Radiation Safety Plan

The BMS in a radiopharmaceutical facility is dual-validated: as a GxP system under EU GMP Annex 11 for the GMP scope, and as a radiation safety information system under the facility Radiation Safety Plan referencing ARPANSA RPS 8 and RPS 14. The DQ/IQ/OQ/PQ validation framework is the same as for any other GxP system; the radiation safety overlay adds the dose monitoring integration, the stack monitor integration, the alarm tier for radiation events, and the change control framework for HEPA and carbon trap change-out as radiation-exposure events.

Pressure transducers at every cascade boundary including the special case of the hot cell negative pressure inside the surrounding cleanroom positive pressure. Logging at 1-minute resolution minimum. Warning at 50 percent of design differential, critical alarm at 25 percent or inversion.

Temperature and humidity loggers at every classified zone and the inpatient radiation isolation ward. 5-minute resolution minimum. Data retained for the life of the manufactured batch plus 5 years minimum per TGA, longer per ARPANSA for the radiation safety record.

HEPA differential pressure across every filter bank with change-out alarm at twice clean-state. The HEPA change-out is a radiation-exposure event requiring Radiation Safety Plan coordination, not simply a maintenance work order.

Activated carbon iodine trap differential pressure with change-out alarm at twice clean-state. The carbon change-out is a radioactive waste consignment under ARPANSA RPS 5 requiring documented packaging, transport and disposal.

Stack continuous air monitor (CAM) integrating gamma channels by energy (allowing isotope identification), specific iodine channel for I-131 364 keV line, particulate channel with auto-advance filter sampler. Alarm thresholds at 25 percent and 100 percent of the ARPANSA RPS 5 release limit. Backup power that holds the stack monitor through grid loss.

Oxygen depletion monitors in every cryogenic storage room, every SF6-handling area, every helium-handling area. Alarm at 19.5 percent O2 with emergency ventilation activation.

Vapour monitors at breathing height in the radiochemistry suite for acetonitrile (40 ppm STEL), ethanol (1,000 ppm 8-hour TWA), methanol (200 ppm), dichloromethane (50 ppm STEL), chloroform (10 ppm STEL), hydrogen fluoride (1.8 ppm STEL) where applicable, hydrogen cyanide (5 ppm STEL) where applicable, ozone (0.1 ppm STEL).

Personal dosimetry integration with the operator dose monitoring system feeding the BMS for trend analysis. Every operator carries an electronic personal dosimeter (EPD) with whole-body dose and extremity dose channels. The cumulative occupational dose is reviewed monthly against the ICRP 103 limits.

Construction sequencing and the SBKJ machine pattern

A new-build radiopharmaceutical or nuclear medicine HVAC scope typically runs 12 to 24 months from possession through commissioning, longer for ANSTO-scale or major synchrotron buildouts. The sequence is broadly: months 1 to 3 base-build alterations including the lead shielding installation by specialist nuclear shielding fabricators; months 2 to 6 fabrication and delivery of the 316L stainless steel hot cell exhaust collars, HEPA BIBO housings, activated carbon iodine trap housings, delay tanks and stack discharge ductwork; months 4 to 10 ceiling-void rough-in for cleanroom supply, return, exhaust, BMS and process services; months 8 to 14 cleanroom partition and ceiling installation, HEPA plenum mounting, hot cell installation by specialist hot cell vendors; months 12 to 18 diffuser, grille, HEPA filter installation and radiochemistry module integration; months 14 to 20 SMACNA leakage testing, pressure verification, ISO 14644 validation, HEPA integrity testing and activated carbon challenge testing; months 18 to 24 final commissioning, BMS DQ/IQ/OQ/PQ validation, radiation safety qualification, TGA radiopharmaceutical licence application, ARPANSA source licence application or amendment.

The SBKJ machine recommendation

The SBAL-V auto duct line is the SBKJ flagship for the high-output, stainless-capable fabrication required by radiopharmaceutical, nuclear medicine, cyclotron PET and theranostics scopes. Specifications: 16 metres per minute working speed, 87 kilowatt installed power, 0.5 to 1.5 millimetre coil thickness, 1,500 millimetre maximum coil width. The line is configured for Type 316L stainless coil with mill-certified traceability — the coil release record captures the heat number at line entry and ties it to the production batch, satisfying TGA radiopharmaceutical GMP, ARPANSA inspection and FDA pre-approval inspection. The line switches to Type 304 for support zones and to galvanised for unclassified corridor and warehouse scope through the same forming train with a documented changeover sequence. The TDF flanging operation accepts gasketed sealing for HEPA-grade integrity and for VHP-compatible bubble-tight damper integration.

For fabricators serving radiopharmaceutical scopes as part of broader healthcare and cleanroom packages, the SBAL-III (14 metres per minute, 15.7 kilowatt) is the cost-effective workhorse. The SBSF-1525 spiral former (2.5 kilowatt) handles the round duct for cleanroom return riser, HEPA bank distribution and lyophiliser exhaust. The SBFB-1500 (7.5 kilowatt, 1.20 metres per minute) handles higher-pressure spiral for stack discharge and the delay tank cylindrical shell. The SB-ZF1500 hydraulic folder produces the bespoke offsets and the SBPC1500 plasma cutter handles HEPA plenum cutouts, hot cell exhaust collar cutouts and the stack discharge transitions.

Welded stainless components — the hot cell exhaust interface plates, the HEPA H14 BIBO filter housings, the activated carbon iodine trap housings, the delay tanks, the BSC exhaust hoods, the inpatient radiation isolation ward exhaust ductwork — are produced using SBKJ stitchwelder equipment with the SBSF-1525 stitchwelder running TIG seam welding for pressure-vessel-grade integrity. The SBLR-600 longitudinal welder (7.6 metres per minute) handles the long stainless seams characteristic of stack discharge, delay tank cylindrical shells and BSC exhaust hood fabrication. Heavy-gauge fire-rated duct at 250 degrees Celsius for 2 hours uses the SBSF-1525 stitchwelder for AS 1530.4 fire-rated wrap integration.

Lead-shielded duct sections (Pb-lined at 6 to 50 millimetres of lead) sit outside the SBKJ scope and are supplied separately by specialist nuclear shielding fabricators. The SBKJ engineering team coordinates with the lead shielding fabricator throughout the project to align the stainless interface plate dimensions, the gasketed flange details and the lead shielding labyrinthine penetration geometry. Oxygen-free copper duct for synchrotron RF cavity and electron-gun applications is fabricated by manual stitchwelding outside the SBKJ auto-line scope and is the specialist vendor's deliverable.

Commissioning, validation and operational handover — DQ/IQ/OQ/PQ with radiation safety overlay

A radiopharmaceutical HVAC system is not commissioned until every parameter has been measured, recorded and signed off through DQ/IQ/OQ/PQ. The radiation safety overlay adds the HEPA and carbon trap radiation challenge testing, the stack monitor calibration, the pressure cascade verification including the special hybrid cascade, and the Radiation Safety Plan integration.

Design Qualification (DQ)

DQ documents that the HVAC design meets the user requirements (URS), the regulatory requirements (TGA radiopharmaceutical, PIC/S, ARPANSA RPS 8 and RPS 14), and the radiation safety requirements (ICRP 103 dose limits, ALARA framework). DQ deliverables: URS sign-off; Functional Specification; Design Specification; HAZOP and risk assessment under ICH Q9; review of compliance with ARPANSA RPS codes and TGA TGO 92. DQ is completed before fabrication.

Installation Qualification (IQ)

IQ documents that the HVAC system is installed in accordance with the design and the manufacturer's specification. IQ deliverables: as-installed drawings; equipment serial number register; material certificates for every stainless coil heat number; lead shielding fabricator certificates for the Pb-lined duct sections; SMACNA leakage test reports per section; calibration certificates for every BMS sensor and transducer including stack monitor channels; pre-commissioning checklist sign-off. IQ is completed before start-up.

Operational Qualification (OQ)

OQ documents that the HVAC system operates within design parameters across the full operating range. OQ deliverables: air balancing report (every diffuser, grille and exhaust measured); pressure relationship verification per cascade boundary including the hybrid cascade (cleanroom positive to corridor while hot cell negative to cleanroom); ACH verification per zone; temperature and humidity baseline over 7 days minimum; HEPA integrity test per filter per IEST-RP-CC034; activated carbon challenge test per ASTM D3803; ISO 14644 particle count validation per zone; stack monitor calibration with traceable radiation sources; BMS point list verification; alarm threshold verification by simulated faults; oxygen depletion monitor functional test; SF6 monitor functional test where applicable; fire and smoke damper test per damper; emergency power changeover test for stack exhaust and critical-power zones. OQ is completed before product introduction.

Performance Qualification (PQ)

PQ documents that the HVAC system operates within design parameters under routine production conditions. PQ deliverables: ISO 14644 in-operation particle count per zone; environmental monitoring with settle plates, surface contact plates and active air sampling over the documented qualification period; contamination control strategy validation; stack monitor performance over the qualification period; operator dose monitoring baseline showing routine doses well within ICRP 103 limits; pressure cascade stability through the operational scenarios; full BMS data review for the qualification period. PQ is completed before commercial production release or clinical use.

The handover binder integrated with TGA, ARPANSA and Radiation Safety Plan

The handover binder integrates the DQ/IQ/OQ/PQ outputs with: SMACNA/AS 4254 leakage test reports per duct section; pressure relationship test logs including the hybrid cascade; ACH verification logs per diffuser and grille; HEPA integrity certificates per filter; activated carbon challenge certificates per trap; ISO 14644 particle count validation per zone; temperature and humidity baseline and 7-day routine logs; BMS point list with alarm verification; stack monitor calibration certificates with radiation source traceability; oxygen depletion monitor calibration certificates; vapour monitor calibration certificates; mill certificates per stainless heat number with traceability to the duct section; lead shielding fabricator certificates for Pb-lined duct sections; AS/NZS 60079 hazardous area classification dossier where applicable; ARPANSA Radiation Safety Plan integration documentation; TGA radiopharmaceutical licence application documentation. The binder is the basis of the TGA licence application, the ARPANSA source licence application or amendment, and every subsequent inspection through the facility lifetime.

Common radiopharmaceutical and nuclear medicine HVAC mistakes

The mistakes below account for most of the rework we have seen on Australian radiopharmaceutical, cyclotron PET, nuclear medicine and theranostics HVAC projects. Each is cheap to fix at design stage and expensive (or impossible) to fix on a licensed manufacturing or clinical site.

Mistake 1 — Single uniform pressure cascade without the hybrid hot cell negative

Designing the radiopharmaceutical cleanroom as a conventional GMP positive cascade without the hot cell negative pressure overlay leaves the operator interface (the glove ports or the BSC work-zone opening) at zero or even slightly outward airflow direction. Any released radionuclide enters the cleanroom rather than the exhaust. The fix is the hybrid pressure cascade with the cleanroom positive to corridor and the hot cell negative to the cleanroom, achieved by independent hot cell exhaust drawing into the lead-shielded enclosure.

Mistake 2 — Missing activated carbon iodine trap on I-131 exhaust

I-131 is volatile under operating conditions and escapes through HEPA filtration unimpeded — HEPA captures particulate but not vapour. Without activated carbon trapping, the I-131 reaches the stack and contributes to the stack release activity, potentially exceeding the ARPANSA RPS 5 limits. The fix is TEDA and KI impregnated activated carbon downstream of HEPA on every exhaust line handling I-131.

Mistake 3 — Galvanised duct on radioactive exhaust paths

Galvanised steel corrodes under chronic radionuclide deposition (the radionuclide chemistry tends to be slightly acidic with the radiolysis products), and the zinc oxide surface sheds particulate that compromises HEPA loading. The fix is Type 316L stainless steel for the entire exhaust path from hot cell collar to stack discharge.

Mistake 4 — Inadequate delay tank residence on short-lived isotope exhaust

A delay tank sized too small allows F-18, C-11, N-13 and O-15 to reach the stack while still active, potentially exceeding stack release limits and triggering ALARA review. The fix is a delay tank sized for the longest-lived produced isotope at the minimum exhaust flow, typically 30 to 60 minutes residence for a clinical PET site.

Mistake 5 — Stack discharge re-entrainment at outdoor air intake

Radiopharmaceutical exhaust discharged too close to outdoor air intakes re-enters through the intake, contaminating the supply air with radionuclide and exposing staff to the recycled activity. The fix is vertical discharge minimum 3 metres above roof, minimum 8 metres horizontal from any intake, with 12 m/s discharge velocity minimum.

Mistake 6 — No bag-in bag-out on radioactive HEPA

A conventional drop-in HEPA filter in a radioactive exhaust path means the change-out exposes the operator to the spent filter's accumulated activity. The fix is BIBO housings on every HEPA in a radioactive exhaust path with continuous PVC bag change-out under containment.

Mistake 7 — Inadequate radiation streaming control at duct penetrations

A straight duct penetration through the lead shielding wall allows radiation to escape through the duct path regardless of the duct material attenuation. The fix is a labyrinthine penetration with stepped or offset paths through the shielding, designed in coordination with the lead shielding fabricator.

Mistake 8 — No oxygen depletion monitoring in helium or SF6 handling areas

Synchrotron RF cavity helium cool-down events, cryogenic nitrogen vent events, SF6 leaks from HV switchgear and the cyclotron target gas operations can displace breathing air without warning. The fix is oxygen depletion monitors at breathing height alarmed at 19.5 percent O2 with emergency ventilation activation.

Mistake 9 — No vapour monitor in radiochemistry suite for the chemistry solvents

Acetonitrile, dichloromethane, chloroform, methanol and the broader radiochemistry solvent panel can exceed Safe Work Australia WES under abnormal release scenarios. The fix is vapour monitoring at breathing height for the credible chemistry exposure with BMS alarming at 50 percent and 100 percent of the relevant WES.

Mistake 10 — HEPA change-out treated as routine maintenance not as radiation event

A HEPA filter in a radioactive exhaust path is a radioactive waste consignment at change-out. Treating it as routine maintenance exposes the operator to unmanaged dose and creates a non-compliant waste consignment. The fix is a documented HEPA and activated carbon change-out procedure under the facility Radiation Safety Plan with ARPANSA RPS 5 packaging, transport and disposal.

Mistake 11 — Stack monitor not on backup power

The stack continuous air monitor is the public-facing verification that the facility's release stays within ARPANSA RPS 5 limits. Loss of the stack monitor during grid loss means the facility has no release record for the duration. The fix is backup power that holds the stack monitor and the associated BMS recording through grid loss.

Mistake 12 — Inpatient radiation isolation ward HVAC mistaken for general ward

A radiation isolation ward room for I-131 high-dose ablation patients requires single-pass HEPA exhaust with activated carbon iodine trap, lead shielding in the walls and ceiling, and waste-water hold for the patient excreta. A conventional ward HVAC scope does not meet any of these requirements. The fix is dedicated radiation isolation ward HVAC engineered against ARPANSA RPS 14 and AS 2243.4.

Energy, sustainability and operating cost

A radiopharmaceutical or nuclear medicine HVAC system runs continuously because the cleanroom envelope, the pressure cascade, the stack exhaust monitoring and the radiation safety functions must hold continuously regardless of production schedule. For a major radiopharmaceutical manufacturing site (ANSTO Camperdown scale, Telix manufacturing scale, Cyclomedical Cyclopharm production site scale), HVAC energy is typically 3 to 10 gigawatt-hours per year. For a smaller nuclear medicine department or theranostics site, 0.5 to 3 GWh per year. The radiation safety requirements limit the energy-saving options available compared to general healthcare HVAC, but several design choices remain effective.

Variable-speed fans on every supply and exhaust modulated by the BMS to maintain pressure cascade and ACH while reducing energy through low-demand periods (overnight, weekend), occupancy-modulated ACH in the non-classified support zones (the GMP cleanroom and the radioactive exhaust must hold continuously, but the surrounding administrative and warehouse zones can step down overnight), and heat recovery on outdoor air paths using runaround glycol coils or plate heat exchangers (not thermal wheels because cross-contamination risk is unacceptable in the radioactive envelope). The cyclotron and synchrotron thermal stability requirements often dominate the cooling load with the precision optics demanding continuous tight control.

Refurbishment versus new fit-out

A growing share of Australian radiopharmaceutical and nuclear medicine HVAC work is refurbishment of existing facilities to current ARPANSA RPS 8 and TGA TGO 92 standards. The refurbishment challenge is fitting modern HEPA H14, activated carbon iodine trap, BIBO housings, stack monitoring and BMS integration into existing buildings designed for an earlier specification. The decant pattern is common: a phased refurbishment of one hot cell line at a time while the rest of the facility continues operating, or a temporary decant to a contract radiopharmaceutical supplier (ANSTO Camperdown is the dominant decant partner for clinical Tc-99m generators) while the permanent facility is refurbished.

Greenfield replacement is the strategic choice where the legacy facility cannot be brought to current standards without effectively rebuilding it — several Australian nuclear medicine and theranostics operators have built new clinical sites in the past five years rather than refurbishing legacy radiopharmacy hot labs.

Procurement and commercial pattern

Radiopharmaceutical and nuclear medicine HVAC procurement runs through three distinct channels in Australia. The ANSTO and Commonwealth channel — ANSTO Lucas Heights, the Australian Synchrotron, the future Commonwealth nuclear infrastructure — runs procurement through ANSTO's internal capital works programme with major design-and-construct packages tendered to specialist nuclear-experienced construction managers and consultants.

The commercial radiopharmaceutical channel — Telix Pharmaceuticals, Cyclomedical Cyclopharm, GenesisCare Theranostics, Clarity Pharmaceuticals — procures through corporate capital works teams supported by specialist consulting engineers (Aurecon, GHD, WSP and equivalents) with mechanical scope subcontracted to specialist GMP contractors who in turn engage ductwork fabricators.

The hospital and clinical channel — the Royal hospital network, Peter Mac, St Vincent's, I-MED Radiology, Lake Imaging, Lumus Imaging, Capital Radiology — procures through state health infrastructure programmes (Health Infrastructure NSW, Victorian Health Building Authority and equivalents) for the public hospital sites and through corporate capital works teams for the private radiology operators.

SBKJ's role across all three channels is upstream of the project. We supply auto duct production lines — the SBAL-V flagship in 316L specification, the SBAL-III workhorse, the SBSF-1525 spiral former and stitchwelder, the SBLR-600 longitudinal welder — to the mechanical contractors and fabricators producing the ductwork for radiopharmaceutical and nuclear medicine scopes nationally. The standard radiopharmaceutical configuration is the SBAL-V running Type 316L stainless coil for the cleanroom envelope and radioactive exhaust paths, switching to Type 304 for support zones and to galvanised for unclassified corridor and warehouse scope, all within a single shift. The TDF flanging operation runs the same on all three coil types and accepts mastic and butyl sealant for HEPA-grade and VHP-rated integrity. SBKJ engineers in our Box Hill North Victoria office provide design and fabrication support throughout the project lifecycle with a 12-hour reply commitment to specification questions, from a senior engineer rather than a salesperson.

ARBS 2026 and the SBKJ engineering offer

SBKJ Group is attending the ARBS 2026 trade exhibition at the International Convention Centre Sydney in May 2026, presenting the SBAL-V auto duct line in Type 316L stainless configuration alongside the broader SBKJ machine pattern. ARBS is Australia's largest air-conditioning, refrigeration and building services exhibition with the radiopharmaceutical, healthcare, cleanroom and nuclear medicine sectors all represented in the attending consultant, contractor and end-user base. The SBKJ stand will demonstrate the Type 316L stainless coil running through the SBAL-V with mill-certified traceability, the TDF flanging operation, the SBSF-1525 stitchwelder running TIG seam welding for HEPA BIBO housing and activated carbon trap housing fabrication, and the broader machine pattern that supports the Australian radiopharmaceutical, cyclotron PET, nuclear medicine and theranostics HVAC duct fabrication scope.

Conclusion — the forty-year decision

An Australian radiopharmaceutical, nuclear medicine, cyclotron PET or theranostics facility is a 25-to-40-year decision. The HVAC ductwork installed today will still be moving air, holding the hybrid pressure cascade, capturing I-131 vapour on its activated carbon bed, and discharging to the monitored stack when the current operating team has long retired. Designing it against ARPANSA RPS 8 and RPS 14, AS 2243.4 ionising radiation, AS/NZS 2243.3 and 2243.10, TGA TGO 92, PIC/S PE 009 GMP, ICRP 103 dose limits and the ALARA framework — Type 316L stainless steel across the radioactive envelope, HEPA H14 with BIBO change-out at every classified zone, activated carbon iodine trap downstream of every I-131 exhaust, delay tank sized for the produced isotope inventory, stack monitor on backup power, continuous BMS recording integrated with the Radiation Safety Plan, hybrid pressure cascade resolving GMP product protection and ARPANSA radiation containment, fully welded leak-tight Class A SMACNA seal class throughout, robust DQ/IQ/OQ/PQ commissioning and annual re-validation — costs more than a generic ducted HVAC scope. It pays for itself many times over the facility lifetime in reduced operator dose, sustained compliance through every ARPANSA inspection and TGA audit cycle, lower lifecycle replacement cost (because the corrosion-vulnerable and radiation-vulnerable materials are placed correctly at first install), the ability to supply radiopharmaceutical to patients across Australia and the export markets, and continuous patient access to nuclear medicine, PET imaging and theranostics therapy.

The Australian radiopharmaceutical, nuclear medicine and theranostics sector is consolidating around the ANSTO Lucas Heights primary supply (with ANSTO now the world's largest Mo-99 producer following the Petten reactor closure in late 2025), the Australian Synchrotron at Clayton VIC for the broader nuclear science infrastructure, the commercial radiopharmaceutical manufacturers Telix Pharmaceuticals, Cyclomedical Cyclopharm and Clarity Pharmaceuticals, the theranostics treatment network led by GenesisCare across Sydney, Melbourne, Brisbane, Adelaide, Perth, Canberra and the Gold Coast, the major teaching hospital nuclear medicine and theranostics departments at Peter Mac, the Royal hospital network, St Vincent's Sydney and Westmead, and the broader Australian PET-CT and PET-MRI imaging capacity at I-MED Radiology, Lake Imaging, Lumus Imaging and Capital Radiology. SBKJ supplies the auto duct production lines that fabricate the ductwork for these facilities — the SBAL-V as flagship configured for Type 316L stainless work, the SBAL-III as the workhorse, the SBSF-1525 stitchwelder for HEPA BIBO housings and activated carbon iodine trap housings, the SBFB-1500 for delay tank cylindrical shells and stack discharge spiral, the SBLR-600 longitudinal welder for the long seams, the SB-ZF1500 hydraulic folder for bespoke offsets and the SBPC1500 plasma cutter for HEPA plenum and stack discharge cutouts. Our engineering team in Box Hill North Victoria is available to support fit-out contractors, mechanical consultants and radiopharmaceutical capital works teams throughout the design and fabrication cycle.

Whether your project is an ANSTO-scale radiopharmaceutical manufacturing scope at Lucas Heights or Camperdown; a synchrotron beam line refurbishment at the Australian Synchrotron Clayton; a new cyclotron PET production facility at a Cyclomedical Cyclopharm site or a hospital cyclotron; a Lu-177-PSMA-617 or Lu-177-DOTATATE theranostics dispensary at a GenesisCare treatment centre or a Royal hospital; a Telix Pharmaceuticals or Clarity Pharmaceuticals radiopharmaceutical manufacturing buildout; an I-131 inpatient radiation isolation ward room at a tertiary teaching hospital; a PET-CT or PET-MRI imaging suite installation at I-MED Radiology, Lake Imaging, Lumus Imaging or Capital Radiology; or a refurbishment of an existing facility to current ARPANSA and TGA standards — the engineering principles are the same, ARPANSA RPS 8 and RPS 14 are non-negotiable, AS 2243.4 ionising radiation is the foundation Australian Standard, ICRP 103 dose limits with the ALARA framework drive the design target, and the design pattern set out in this guide is the SBKJ engineering team's recommended starting point.

Get an SBKJ engineering review of your radiopharmaceutical, cyclotron PET, nuclear medicine or theranostics HVAC specification →

FAQ

What ductwork design controls radiation hazard in an Australian radiopharmaceutical hot cell exhaust?

The exhaust runs from the lead-shielded hot cell or glove box through a HEPA H14 prefilter, an activated carbon bed sized for radioiodine and short-lived radio-gas capture (typically 50 to 150 mm of TEDA-impregnated carbon at face velocity 0.25 to 0.5 m/s), a delay tank sized for the longest-lived produced isotope, a continuous stack monitor with gamma, iodine and particulate channels, and vertical discharge stack at minimum 3 m above roof with 12 m/s minimum velocity. Type 316L stainless steel ductwork continuously TIG-welded, SMACNA Class 6 leakage at 1.5x maximum operating pressure, SMACNA Seal Class A throughout. Lead-shielded duct sections at the hot cell penetration sit outside the SBKJ scope and are supplied separately. Design governed by ARPANSA RPS 8 and RPS 14, AS 2243.4, ICRP 103 with ALARA.

How is an I-131 radioiodine exhaust designed for an Australian nuclear medicine facility?

The exhaust runs from the dispensing fume cupboard, glove box or hot cell through HEPA H14 prefilter (particulate and aerosol-bound iodine), triple-bed activated carbon with TEDA and KI impregnation (elemental I2, methyl iodide CH3I, inorganic iodide), continuous stack monitor with separate iodine, particulate and gamma channels, vertical discharge stack at minimum 3 m above roof. I-131 derived air concentration (DAC) is 33 Bq/m3 — one of the lowest occupational limits because of thyroid uptake risk. Annual ASTM D3803 challenge testing verifies carbon trap efficiency. Carbon change-out is a radiation-exposure event and a radioactive waste consignment under ARPANSA RPS 5.

What is the radiopharmaceutical dispensary pressure cascade for Lu-177 theranostics manufacturing?

The hybrid pressure cascade: the cleanroom is positive to corridor for GMP product protection while the lead-shielded hot cell or biosafety cabinet within the cleanroom is negative to the cleanroom for ARPANSA radiation containment. The cleanroom HVAC supplies through HEPA H14 at 40 to 60 ACH for the Grade B background at +10 Pa to corridor. The hot cell exhaust is independent, drawing air from the cleanroom into the lead-shielded enclosure at -10 to -30 Pa to cleanroom, exhausting through HEPA H14 / activated carbon iodine trap (if I-131) / delay tank / stack monitor / vertical discharge. ISO 14644 Class 5 (Grade A) at the dispensing point with shielded vial handling and remote dispensing tools.

What HVAC is required for an Australian cyclotron PET production facility?

The cyclotron vault is shielded at 1.5 to 2.5 m of high-density concrete plus borated polyethylene with dedicated low-rate ventilation at 4 to 6 ACH through labyrinthine penetrations. Exhaust through HEPA H14 BIBO housing and delay tank sized for N-13 (10 min), O-15 (2 min) and Ar-41 (110 min) decay before stack discharge with continuous stack monitoring. The downstream radiochemistry hot cell line sits in a Grade C cleanroom at ISO Class 8 in operation with the lead-shielded hot cells (50 to 100 mm Pb) operating at negative pressure inside the positive-pressure cleanroom — the hybrid cascade pattern. Type 316L stainless steel ductwork throughout the radioactive exhaust path. Cyclomedical Cyclopharm, ANSTO, Auburn Hospital, Royal Brisbane, Royal Perth and equivalent sites.

How does ANSTO produce Mo-99 and what HVAC supports this?

ANSTO operates the OPAL reactor (20 MW, Open Pool Australian Lightwater) at Lucas Heights NSW — Australia's only nuclear reactor and the world's largest single Mo-99 source following the Petten reactor closure in late 2025. Mo-99 (66-hour half-life) is produced by neutron fission of low-enriched uranium targets, separated in heavily-shielded chemical processing lines, and packaged as Mo-99/Tc-99m generators. HVAC scope: reactor hall HEPA H13/H14 exhaust with stack continuous air monitor; hot cell line at ISO Class 5 inside lead-shielded hot cells with remote manipulators for generator manufacturing; I-131 production line with TEDA-impregnated activated carbon iodine trap; Lu-177 production line for theranostics; aseptic dispensary at ISO 5. The Mo-99 supply underpins approximately 80 percent of all nuclear medicine imaging globally.

What HVAC supports the Australian Synchrotron storage ring at Clayton VIC?

The Australian Synchrotron at Clayton is a 3 GeV electron storage ring with 216 m circumference and 32 active beam lines operated by ANSTO. HVAC: storage ring tunnel climate-controlled at 20 to 22 degrees Celsius at +/-0.5 K stability and 35 to 45 percent RH at +/-5 percent. Radiation-shielded ring tunnel at 1 to 2 m concrete with supply and exhaust through labyrinthine penetrations. Air-activated N-13 from N2 requires HEPA H13 exhaust with short delay path before stack discharge and continuous monitoring. SF6 detection at floor in areas where RF cavity insulation, klystron HV switchgear or electron gun HV operate (SF6 is heavy gas, asphyxiation risk, potent greenhouse gas at GWP 23,500). Oxygen depletion monitors at breathing height alarmed at 19.5 percent. Type 316L stainless steel ductwork in experimental areas; Type 304 acceptable in administrative and plant areas.

What is theranostics and what HVAC does it require in Australian cancer centres?

Theranostics combines a diagnostic imaging radiopharmaceutical (Ga-68 PET or F-18 PET) with a therapeutic radiopharmaceutical (Lu-177 beta-emitter, Y-90 beta-emitter or Ac-225 alpha-emitter) targeted to the same biological pathway. Leading Australian theranostic pairs: Ga-68-PSMA-11 imaging (Telix Illuccix) and Lu-177-PSMA-617 therapy for metastatic prostate cancer; Ga-68-DOTATATE imaging and Lu-177-DOTATATE therapy for neuroendocrine tumours; Y-90 microsphere SIRT for hepatic malignancies. GenesisCare Theranostics is the largest Australian provider across Sydney, Melbourne, Brisbane, Adelaide, Perth, Canberra and Gold Coast. HVAC at each site: ISO Class 5 dispensary with lead-shielded hot cell, dedicated injection room with shielded chair and exhaust, patient holding area for post-injection radiation hold, inpatient radiation isolation ward for I-131 ablation patients with single-pass HEPA exhaust through activated carbon iodine trap.

What chemical and radiological limits drive cyclotron PET radiochemistry HVAC design?

Radiological DACs: tritium H-3 at 7,400 Bq/m3; I-131 at 33 Bq/m3 (limiting for thyroid uptake); F-18, C-11, N-13, O-15, Ga-68, Zr-89, Lu-177, Y-90, Sm-153 and Ho-166 governed by ICRP 103 annual dose limits (public 1 mSv/year, occupational 20 mSv/year averaged over 5 years, no single year above 50 mSv). Chemical WES: acetonitrile 40 ppm STEL; ethanol 1,000 ppm 8-hour TWA; methanol 200 ppm; dichloromethane 50 ppm STEL; chloroform 10 ppm STEL; H2 below 25 percent of LEL; HF 1.8 ppm STEL where F-18 target HF capture runs; HCN 5 ppm STEL where Cu-64 chemistry runs; ozone 0.1 ppm STEL where UV/X-ray radiolysis produces O3 and NOx. Helium and argon as asphyxiation risk requiring O2 depletion monitoring at 19.5 percent. SF6 as heavy gas asphyxiation and greenhouse gas risk.

Which SBKJ machines produce ductwork for an Australian radiopharmaceutical facility?

The SBAL-V auto duct line is the SBKJ flagship for high-output stainless-capable rectangular duct fabrication — 16 m/min, 87 kW, 0.5 to 1.5 mm coil, 1,500 mm coil width, configured for Type 316L stainless with mill-certified traceability for TGA radiopharmaceutical GMP and ARPANSA inspection. SBAL-III (14 m/min, 15.7 kW) is the cost-effective workhorse. Round duct uses SBSF-1525 (2.5 kW) spiral former or SBFB-1500 (7.5 kW, 1.20 m/min) for higher-pressure stack discharge spiral. SB-ZF1500 hydraulic folder for offsets; SBPC1500 plasma cutter for HEPA plenum and stack discharge cutouts. HEPA BIBO housings, activated carbon iodine trap housings, delay tanks, BSC exhaust hoods use SBKJ stitchwelder SBSF-1525 with TIG seam welding; SBLR-600 longitudinal welder (7.6 m/min) for long stack and delay tank seams. SBFB-1500 for delay tank cylindrical shell. Lead-shielded duct sections (6 to 50 mm Pb lining) outside SBKJ scope, supplied by specialist nuclear shielding fabricators.

What ARPANSA codes and Australian Standards govern radiopharmaceutical HVAC?

ARPANSA RPS 8 Code of Practice for Radiopharmaceuticals; ARPANSA RPS 14 Radiation Protection in the Medical Industry; ARPANSA RPS 5 Safe Transport and Disposal of Radioactive Waste; ARPANS Act 1998 source licensing; AS 2243.4 ionising radiation; AS/NZS 2243.3 PC1/PC2/PC3/PC4 biocontainment; AS/NZS 2243.10 LEV laboratory exhaust; AS/NZS 2982 laboratory design; AS 2243.8 fume cupboards; AS 1668.2 mechanical ventilation; AS 4254 ductwork construction; AS 1530.4 fire-rated construction; AS/NZS 4187 sterile reprocessing; AS/NZS 60079 hazardous area where solvent inventory exceeds AS 1940 thresholds. PIC/S Guide to GMP PE 009 and TGA TGO 92 radiopharmaceutical manufacturing standard. ICRP 103 dose limits and ICRP 118 tissue reactions adopted into Australian law via ARPANSA. IAEA Safety Standards Series for international reference. ISO 14644 cleanroom and ASHRAE 170 healthcare HVAC.