Tobacco, Vape and Nicotine Manufacturing HVAC Ductwork — Australian TGA Compliance Guide

Why this guide exists

Australia is, on paper, one of the simpler regulated markets for nicotine and tobacco — there is no domestic cigarette manufacturing, recreational nicotine vape supply is illegal, and the only legal production pathway for nicotine vape products is through Therapeutic Goods Administration approved sponsors or pharmacy compounding under the Special Access Scheme. In practice, that simplicity masks a dense layer of overlapping rules — Therapeutic Goods Order 110 setting the vape product standard, Therapeutic Goods Order 100 imposing pharmaceutical Good Manufacturing Practice on every batch, the Office of Drug Control overseeing nicotine as a scheduled substance, Customs Notice 2024/10 governing import licensing, the Public Health (Tobacco and Other Products) Act 2023 governing every cigarette that passes through a distribution warehouse, and Safe Work Australia setting a hard occupational exposure limit on nicotine itself.

All of those rules land, eventually, on the HVAC engineer. The Therapeutic Goods Administration auditor does not care whether your compounding suite has carpet or epoxy floors — they care whether your supply air comes through a HEPA H13 terminal filter and whether your exhaust strips nicotine before atmosphere discharge. The Safe Work Australia inspector does not weigh your nicotine concentrate — they sample the operator breathing zone. The Office of Drug Control desk officer does not look at your shopfront — they review your batch records and your room classification certificates. Every one of those touchpoints either passes or fails on the ductwork.

This guide is the reference SBKJ engineers use when scoping a nicotine compounding fit-out or a tobacco distribution warehouse extraction system for an Australian client. It is written for the mechanical contractor, the facility manager, the consulting engineer, and the pharmacy proprietor who has just received a Special Access Scheme nicotine compounding scope and realized the existing pharmacy HVAC is nowhere near compliant. It is not legal advice — the TGA and the Office of Drug Control are the only authorities on regulatory interpretation. But it is engineering advice, written by people who have specified, fabricated and installed pharmaceutical-grade stainless ductwork for the kind of facility this rulebook expects.

The Australian regulatory framework — a single layered picture

Before touching air handling, the engineer needs a clean picture of who regulates what. The Australian nicotine regulatory stack has four major layers, plus a tobacco-specific layer that overlaps for distribution facilities.

Therapeutic Goods Act 1989

The Therapeutic Goods Act 1989 is the master Commonwealth statute. It establishes the Therapeutic Goods Administration as the regulator, defines a "therapeutic good," and creates the Australian Register of Therapeutic Goods. Nicotine vape products — every category of them, from prescription pods to compounded liquids — fall under this Act because nicotine is scheduled as a substance with therapeutic claims under the smoking cessation pathway. That single fact is what pulls the entire industry into pharmaceutical regulation rather than consumer-goods regulation.

Two implications for HVAC. First, "manufacture" of any therapeutic good in Australia requires either TGA manufacturing licence or operation under the compounding pharmacy exemption. Second, the facility hosting that manufacture must comply with the Code of Good Manufacturing Practice for Medicines, which is the PIC/S Guide adopted by Australia. Both push the ventilation envelope into pharmaceutical-grade territory.

Therapeutic Goods Order 110 — the vape product standard

Therapeutic Goods Order 110 (TGO 110) is the substance-and-product standard for therapeutic vape goods. It sets the chemistry: permitted nicotine forms (nicotine base and the salts permitted under the order), permitted carrier solvents (propylene glycol, vegetable glycerin, and limited water content), permitted flavouring categories, and prohibited additives — most famously, the diketones diacetyl and 2,3-pentanedione associated with bronchiolitis obliterans ("popcorn lung"). The order also sets labelling, batch identification, expiry dating and a strict prohibition on disposable single-use vape formats outside the supervised supply chain.

From the HVAC perspective TGO 110 matters for two reasons. First, the prohibited-substance list defines what the engineer must capture — diacetyl and pentanedione may be banned in the formula but trace cross-contamination is a real exposure risk where the same compounding bench is shared with food-grade flavouring batches, so the activated carbon stage must be sized for the broadest plausible VOC inlet, not just the on-spec ingredients. Second, the limits on solvent ratios mean that any well-engineered TGO 110 product is dominated by PG and VG, which sets the exhaust-treatment design point.

Therapeutic Goods Order 100 — GMP for medicines

Therapeutic Goods Order 100 (TGO 100) brings the Pharmaceutical Inspection Co-operation Scheme Guide to Good Manufacturing Practice for Medicinal Products into Australian law. PIC/S Annex 1 deals with sterile manufacture; Annex 9 deals with liquids, creams and ointments — the annex most relevant to nicotine vape compounding. Annex 9 specifies classified zones, supply air filtration, pressure cascade, defined cleaning protocols and validated batch records. Even though pharmacy compounding under the Special Access Scheme uses a partial application of these requirements (proportionate to the specific compounded preparation), TGA inspectors expect to see the principles embedded in any facility producing for human use.

The practical translation: every surface that touches product or product-contact air must be smooth, cleanable, non-shedding and chemically inert to the formula. That definition is what excludes galvanized supply ductwork from compounding suites and pushes the engineer to 316L stainless with welded seams and a defined surface roughness.

Customs Notice 2024/10 — import controls on nicotine vape

Customs Notice 2024/10 codifies the Australian Border Force's enforcement of nicotine vape import controls following the July 2024 reforms. Personal importation of nicotine vape products is prohibited; commercial importation is restricted to TGA-authorized sponsors and to bulk pharmaceutical-grade nicotine for licensed manufacturers and compounders. The notice details documentation requirements (TGA approval reference, ODC handler details, manifest declarations), permissible packaging configurations and the audit trail expected at point of entry.

For a domestic compounding facility this matters because the nicotine concentrate arriving at the loading dock has already passed through a Customs-monitored chain. The receiving room therefore needs a documented quarantine zone, a sampling booth that meets the same operator-exposure standard as the production suite, and an audit trail that links each drum to the originating Customs declaration. The HVAC design must extend the production-room exposure controls back to that sampling and storage area.

Public Health (Tobacco and Other Products) Act 2023

The Public Health (Tobacco and Other Products) Act 2023 consolidated and modernized the older Tobacco Plain Packaging Act 2011 and the Tobacco Advertising Prohibition Act 1992. It governs every tobacco product sold in Australia: plain packaging requirements, mandated health warnings, prohibition on additives that increase palatability, advertising restrictions, retail display rules and importer reporting. Domestic manufacturing of cigarettes has been absent from the Australian market since 2014 (Philip Morris Australia's Moorabbin plant closure) and 2015 (Imperial Tobacco Australia's Sydney plant closure), so the Act in practice governs importation, warehousing, distribution and retailing.

HVAC obligations in tobacco distribution warehouses are less stringent than in nicotine compounding suites, but they are not trivial. Tobacco dust accumulating in supply ductwork creates a hygiene issue (mould-prone humid microclimates) and a fire-load issue (heated tobacco product retail packs contain combustible material). Distribution warehouses for Imperial Tobacco Australia, British American Tobacco Australia (BAT, the largest holder of Australian tobacco market share) and Philip Morris Australia operate to internal corporate ventilation standards more stringent than the public-health Act mandates, primarily for fire-safety insurance reasons.

Office of Drug Control — nicotine as a scheduled substance

The Office of Drug Control (ODC), part of the Department of Health, administers controls on substances scheduled under the Single Convention on Narcotic Drugs and on substances controlled under domestic legislation. Nicotine itself is not scheduled under the Single Convention, but nicotine concentrate handling at certain thresholds triggers ODC licensing through the chain of related amendments to the Customs (Prohibited Imports) Regulations. A compounding pharmacy handling nicotine in the form of pharmaceutical-grade concentrate (typically 100 mg/mL or higher) must register handler details with the ODC, maintain inventory reconciliation records, and operate within secured storage that meets the ODC's physical-security standard.

For the HVAC engineer the practical implication is that the ODC-licensed nicotine concentrate storage room is a regulated space with its own access controls, exhaust treatment, and emergency response protocols. The storage room is exhausted independently of the compounding suite — never recirculated, never shared — to allow rapid purge in the event of a concentrate spill.

Safe Work Australia — occupational exposure limit

Safe Work Australia maintains the Workplace Exposure Standards for Airborne Contaminants, which list nicotine (CAS 54-11-5) with a Time Weighted Average exposure limit of 0.5 mg/m³ over an 8-hour working day, carrying a skin notation because nicotine is rapidly absorbed through intact skin. This is the hard engineering ceiling — every LEV calculation, every breathing-zone monitoring exercise, and every commissioning protocol references this number.

To put the figure in context: 0.5 mg/m³ is the same order of magnitude as the workplace exposure limit for many pharmaceutical actives. For an operator weighing 100 mg of nicotine concentrate at an open balance, the airborne release rate has to be controlled to a level where 8 hours of weighing activity produces less than 4 mg of breathing-zone exposure (0.5 mg/m³ × 8 m³ inhalation volume). This is achievable with engineered LEV but not achievable with general room ventilation alone — which is why every credible nicotine compounding suite has a downflow workbench or partial enclosure over the weighing operation.

Who actually operates in Australia — the regulated landscape

The list of operators with skin in this game is shorter than many overseas markets, and the engineering implications differ markedly between categories.

Tobacco distribution and importation

Philip Morris Australia distributes the Marlboro family and a portfolio of heated tobacco products in Australia. With no domestic manufacturing since 2014, all stock arrives through Sydney and Melbourne ports and flows through bonded warehouses to retail. The HVAC engineering inside those warehouses is conventional commercial HVAC plus heightened fire detection — there is no GMP cleanroom requirement, but the climate-controlled storage volumes (typically 16–20 °C, 45–55% RH) require robust dehumidification ductwork to protect product shelf life.

Imperial Tobacco Australia, part of the Imperial Brands group, occupies a similar position post-2015 plant closure. Distribution is from contracted warehouses; the brand portfolio includes Horizon, Peter Stuyvesant and JPS. Imperial's internal standards for distribution-warehouse ventilation set HEPA-grade prefiltration on outside air intakes (to keep settled dust off retail packaging) and require sealed ductwork on supply runs — a Class B leakage rating to EN 1507 minimum, which is stricter than the AS/NZS 4254 Class A baseline. SBKJ-style mid-pressure rectangular duct lines configured with TDF-flange and double-skin gasketing meet that requirement comfortably.

British American Tobacco Australia (BAT Australia) is the largest single tobacco distributor in the country, headquartered in Sydney, with a portfolio that includes Winfield, Dunhill, and a growing heated-tobacco range. BAT's Sydney distribution footprint operates under group standards that exceed Australian code minimums on both fire-detection coverage and air filtration. Heated tobacco product warehousing in particular has tighter humidity control bands than traditional cigarette stock — the consumables for heated systems are sensitive to moisture migration.

Therapeutic nicotine vape — TGA-approved sponsors

VapingMedical is among the longest-standing TGA-approved sponsors of prescription nicotine vape products in Australia, with a portfolio registered through the standard ARTG process. Sponsor manufacturing for TGA-registered vape goods (as opposed to compounded supplies) requires the full force of TGO 100 GMP, which means a manufacturing licence, a manufacturing site under PIC/S Annex 9, and the kind of HVAC infrastructure that resembles a small pharmaceutical facility more than a pharmacy.

Schwartz Industries operates in the broader regulated nicotine and pouch space, with products under TGA review as the regulator works through the evolving classification of nicotine pouches relative to vape liquids. Pouch manufacturing (a powder-product form factor) has different HVAC implications — particulate exposure becomes the dominant occupational hygiene concern rather than VOC capture — but the same principles of cleanroom classification, material selection and exhaust treatment apply.

Australian Vape Co and a small number of similar operators run compliant compounding facilities at the larger end of the pharmacy spectrum, producing patient-specific preparations at volume under the Special Access Scheme. These facilities sit between a corner pharmacy and a full sponsor manufacturer in scale and HVAC sophistication: typically 200–500 m² of classified production space, full pharmaceutical AHU plant, and dedicated nicotine handling rooms with documented breathing-zone monitoring.

Pharmacy-compounded nicotine vape

Liber Pharmatech is among the TGA-licensed pharmacist-compounding operators producing nicotine vape preparations under the Special Access Scheme. The compounding-pharmacy model is the dominant pathway for legal nicotine vape access in Australia — a prescribing doctor writes a prescription, the patient presents at a participating pharmacy, and the pharmacist compounds a patient-specific preparation to the prescription. Approximately 50 TGA-licensed compounding pharmacy sites participate at any given time, though that number fluctuates as the regulatory framework continues to evolve.

For an HVAC engineer the compounding-pharmacy use case is the most common engagement. A typical scope is a 30–60 m² classified compounding suite added to an existing pharmacy footprint, served by a dedicated air-handling unit with HEPA H13 supply, dedicated exhaust through carbon and HEPA, a 100 mg/mL nicotine concentrate ODC-licensed storage cabinet with its own exhaust, and a small bulk-solvent (PG/VG) store with ATEX zoning review. Total ducted air at 20–30 ACH on the compounding suite plus 8–12 ACH on the surrounding pharmacy plus dedicated extracts adds up to a meaningful retrofit but a manageable one — typically 3–6 weeks of fit-out from sealed shell to TGA-ready hand-over.

Importation routes

Bulk pharmaceutical-grade nicotine concentrate destined for Australian compounding pharmacies and TGA-approved sponsor manufacturers arrives by air freight under controlled documentation. The dominant origin jurisdictions are regulated pharmaceutical-grade suppliers in Singapore, Mexico, and selected European Pharmacopoeia compliant manufacturers. Customs Notice 2024/10 details the documentation chain — TGA sponsor reference, ODC handler ID, manifest disclosure — and the receiving facility's quarantine arrangements form part of the audit trail.

Cleanroom classification and air change rates

The engineering core of any nicotine compounding HVAC design is the cleanroom classification scheme. Australia uses ISO 14644-1 for particle classification, harmonized with PIC/S Annex 1 grade letters (A, B, C, D). The mapping for compounding pharmacy nicotine vape work, drawing on Annex 9 (Liquids, Creams and Ointments) rather than Annex 1 (Sterile Products):

Anteroom and gowning — Grade D / ISO Class 8

The personnel airlock and material airlock leading into the compounding suite operate at Grade D. In ISO terms that is Class 8 in operation: not more than 3,520,000 particles ≥ 0.5 µm per cubic metre. Practical air change rate is 8–12 ACH, with supply through ceiling-mounted F8 prefilters. Wall and floor finish must be cleanable epoxy or vinyl welded coving; ductwork material can be galvanized in the anteroom upstream of the inner door, transitioning to 316L stainless across the threshold into the classified space.

Compounding suite — Grade C / ISO Class 7

The compounding suite itself operates at Grade C: ISO Class 7 in operation (not more than 352,000 particles ≥ 0.5 µm per cubic metre during work) and ISO Class 8 at rest. Practical air change rate is 20–30 ACH. Supply air is delivered through HEPA H13 terminal filters at the ceiling — typically four or six 600 × 600 mm fan-filter units in a 30 m² suite — with low-level returns at two diagonal corners to encourage downward airflow over the work zone. All ductwork inside the classified envelope is 316L stainless with TIG-welded longitudinal seams. The room operates at +15 Pa relative to the gowning anteroom.

Filling workstation — Grade B / ISO Class 5 (LAF)

The actual nicotine concentrate measurement, dilution and filling operation occurs under a vertical laminar airflow workstation operating at ISO Class 5 (not more than 3,520 particles ≥ 0.5 µm per cubic metre). The LAF unit delivers a unidirectional vertical airflow of 0.36–0.54 m/s through a HEPA H14 final filter. This workstation is the actual product-contact zone. The downflow simultaneously protects the product from contamination and the operator from airborne nicotine — provided the workstation is correctly positioned relative to the room exhaust so that LAF discharge sweeps away from the operator and toward a return path.

Quality control and finished goods — Grade D

Adjacent quality-control sampling, labelling, secondary packaging and finished-goods quarantine zones operate at Grade D. The reduced classification is acceptable because the product is contained in sealed primary packaging by this point. Ductwork material can revert to coated galvanized in finished-goods storage, though many designers retain 316L through the QC area for cleanability consistency.

Air handling unit and ductwork architecture

The AHU plant for a TGA-licensed compounding pharmacy is a small but specifically configured machine. The configuration is shaped by three constraints: HEPA terminal filtration at the room, pressure cascade across the suite envelope, and the need to handle nicotine-laden return air without contaminating any other space.

Supply air handling unit

A typical compounding-suite AHU comprises, in order from outside air intake: motorized damper, frost coil (in Melbourne and Tasmanian latitudes), G4 prefilter, F7 secondary filter, chilled water cooling coil, hot water heating coil, EC plug fan, F9 pre-final filter and acoustic attenuator. Supply temperature setpoint is typically 18–22 °C with humidity controlled to 30–55% RH. The AHU itself can sit in a plant area outside the classified envelope; supply ductwork transitions from galvanized in the AHU plant room to 316L stainless at the threshold into the classified suite.

The HEPA H13 final filtration is delivered at the room ceiling — never inside the AHU casing — because in-AHU HEPA is impossible to integrity-test after installation and is subject to the full thermal cycling of the chilled water coil. Ceiling-mount fan-filter units (FFUs) provide H13 at the room interface, can be integrity-tested in situ with PAO challenge, and are individually replaceable without disrupting the rest of the supply system.

Return and exhaust strategy

The fundamental decision is full once-through (no recirculation) versus partial recirculation. For nicotine compounding, the safe and defensible engineering choice is full once-through extraction — every cubic metre of supply air exits the building through the carbon-and-HEPA exhaust train. Partial recirculation would mean nicotine-laden return air re-entering the AHU coil bank, with cross-contamination risk to any other space served by the same plant.

The exhaust ductwork from the compounding suite runs in 316L stainless to the dedicated exhaust unit. The exhaust unit comprises: G4/F7 inlet prefilter, activated carbon canister bed sized for nicotine and flavour-compound capture, HEPA H14 final filter, EC plug fan, and acoustic attenuator. Discharge is at roof level through a stack designed to AS 4426 for laboratory-style exhaust dispersion — typically a tall, narrow, vertically discharging "rocket" stack with no rain cap that would re-entrain exhaust.

Pressure cascade and door interlocks

The pressure cascade is the safety net behind every other control. Compounding suite at +15 Pa relative to gowning, gowning at +15 Pa relative to general pharmacy, general pharmacy at +5 to +10 Pa relative to outdoors. ODC-licensed nicotine concentrate storage cabinet at -5 to -10 Pa relative to surrounding room (it is exhausted). PG/VG bulk storage at -5 Pa relative to surrounding room.

Door interlocks prevent simultaneous opening of inner and outer airlock doors. Magnehelic gauges on each side of the airlock display real-time differential pressure; audible alarms trigger at ±5 Pa from setpoint. The PLC governing the AHU and the exhaust fan modulates fan speed via EC drives to hold the pressure differential as filter loadings increase over the maintenance interval.

Material selection — why 316L stainless and not galvanized

The single highest-value engineering decision in this entire scope is the choice of duct material in the classified zone. The answer is unambiguous — 316L stainless steel for the compounding suite envelope, the exhaust train, and the ODC storage cabinet — and the reasons reward unpacking.

Nicotine vapour and zinc surfaces

Nicotine is a tertiary amine and a strongly alkaline molecule. At room temperature its vapour pressure is low (around 4 Pa at 25 °C) but non-zero — every open container of concentrate, every wiped spill, every aerosol release during weighing produces a measurable airborne fraction. That airborne nicotine has a strong adsorption affinity for metal oxide surfaces, particularly zinc oxide (the surface chemistry of galvanized steel). Adsorbed nicotine re-emits at low but persistent rates for weeks or months after the initial exposure — a phenomenon well documented in tobacco-smoke "thirdhand smoke" research and directly relevant to any HVAC surface exposed to nicotine-laden process air.

From a GMP perspective this re-emission breaks the cleanability requirement of TGO 100. You cannot validate cleaning of a zinc-galvanized supply duct after a nicotine exposure event — the cleaning solvent removes surface residue but the adsorbed layer remains. Stainless 316L, by contrast, has a chromium-rich passive oxide layer (Cr₂O₃) that does not chemisorb amines and can be wiped clean to a validated endpoint with isopropyl alcohol or a sodium-hypochlorite solution.

Propylene glycol and vegetable glycerin film formation

The second material issue is solvent. Propylene glycol and vegetable glycerin are the carrier solvents specified by TGO 110. Both are hygroscopic — they absorb water from humid air — and both have surface tensions and vapour pressures that allow them to deposit thin liquid films on cool duct surfaces. Over the operating life of the facility those films accumulate, hold trace nicotine and flavour acids, and create localized chemistries that attack zinc coatings (releasing zinc fume, generating white rust) and silicone or natural-rubber duct gaskets.

316L stainless is chemically inert to PG, VG, ethanol, isopropyl alcohol, sodium hypochlorite, hydrogen peroxide and the common cleaning agents used in pharmaceutical compounding. With proper longitudinal weld profile and a polished interior surface (Ra ≤ 0.8 µm), it presents no localized stress points where film deposition becomes problematic.

Flavour compound chemistry

The third factor is flavour-compound exposure. TGO 110 prohibits diacetyl and 2,3-pentanedione but permits a range of food-grade flavouring compounds — esters, aldehydes, terpenes — at controlled concentrations. Many of these flavour compounds are reactive: esters can hydrolyze in the presence of water films, aldehydes can oxidize, and terpenes can polymerize on warm surfaces. Each reaction product is a fresh exposure to the duct interior, and over a 10–15 year facility life the accumulated chemistry on a galvanized duct is unpredictable. Stainless steel removes that uncertainty.

Practical specification

The SBKJ specification for a TGA-compliant compounding-suite supply and exhaust duct, derived from this analysis, is:

• Material: 316L stainless steel, mill-test-certified, traceable to EN 10204 3.1 mill certificates.
• Thickness: 0.8 mm for branch ductwork up to 400 mm diameter equivalent, 1.0 mm for main risers up to 800 mm, 1.5 mm for plant-room transitions and discharge stacks.
• Longitudinal seam: TIG-welded, no rolled lock seam, no rivets, no spiral seam in production-zone runs.
• Interior surface: pickled and passivated per ASTM A380, surface roughness Ra ≤ 0.8 µm verified by stylus profilometer on three samples per fabricated batch.
• Flanges: 316L stainless, machined faces, EPDM or platinum-cured silicone gaskets, stainless bolts.
• Joints: bolted flange with continuous gasket, no slip joints, no draw bands inside the classified envelope.
• Inspection: boroscope every welded joint with photographic record, included in the handover dossier.

HEPA filtration and carbon exhaust treatment

The filtration train is where the regulatory load and the engineering load most directly meet. Three points govern.

Supply HEPA H13 at the room

HEPA H13 filters (per EN 1822-1) provide ≥ 99.95% efficiency at the Most Penetrating Particle Size (typically 0.1–0.2 µm). The supply terminals in a Grade C compounding suite use H13 because that is the standard set by PIC/S Annex 9 for non-sterile clean preparation areas. H14 is overspecification at the supply side; H13 is sufficient and reduces fan-energy penalty (the higher the filter grade, the higher the pressure drop and the larger the supply fan).

Each terminal H13 unit is integrity-tested at installation using a polyalphaolefin (PAO) challenge aerosol — a standard pharmaceutical procedure that demonstrates the installed filter and its frame seal have no leaks. Test results are recorded in the validation dossier and re-tested annually as part of the operational qualification cycle.

Exhaust carbon canister

The activated carbon canister captures nicotine vapour and the broader VOC mix from flavouring compounds, solvent vapour and any trace impurities. Sizing is driven by inlet concentration, residence time and breakthrough criteria. For a 30 m² compounding suite running 25 ACH (2,250 m³/h supply, full once-through), a carbon bed of 50–80 kg of pelletized coconut-shell activated carbon at 100–150 mm bed depth delivers a residence time around 0.2 seconds — adequate for typical nicotine vapour loadings with a breakthrough interval of 6–12 months under normal operation.

The change-out schedule is set during operational qualification by sampling carbon-outlet concentration weekly for the first three months and developing a loading curve specific to the facility. Some operators retrofit a chemiresistive nicotine sensor at the carbon outlet to trigger automatic change-out alerts at half-breakthrough; others rely on calendar-based replacement with monthly spot-sampling for verification.

Exhaust HEPA H14 final

Downstream of the carbon canister, an HEPA H14 final filter (≥ 99.995% MPPS efficiency) sits before the exhaust fan. Its function is to capture carbon dust, particulate breakdown products and any aerosol mist that escapes the suite return inlet. HEPA H14 is the standard final-discharge stage for pharmaceutical exhaust because it allows the final discharge to be treated as essentially clean for permit purposes, simplifying the environmental discharge conversation with local authorities.

Stack discharge

The discharge stack is sized to AS 4426 dispersion principles or equivalent ASHRAE 62.1 stack-height guidance. Vertical "rocket" discharge at 12–15 m/s exit velocity, stack top at least 3 m above any rooftop air intake within a 15 m radius, no rain cap, no horizontal discharge. The combined HEPA H14 final stage plus the dispersion stack design pushes the discharge concentration of any residual nicotine well below ambient air-quality reference levels.

Solvent storage zoning — ATEX and NFPA 30

Propylene glycol, vegetable glycerin and ethanol (where used as a co-solvent for certain flavour-carrier work) introduce a flammable-liquid storage problem distinct from the nicotine-exposure problem.

PG and VG classification

Propylene glycol has a flash point around 99 °C; vegetable glycerin around 160 °C. Both are non-flammable at room temperature and below — neither is classified as a flammable liquid under Australian Dangerous Goods Code or NFPA 30. They are, however, combustible if heated, and they accumulate in duct films as discussed earlier. The storage classification is therefore a fire-load issue rather than an explosion issue — bulk storage at 20 °C does not require ATEX zoning, but the sprinkler design and the building fire load assessment must account for the stored volume.

Ethanol classification

Ethanol, by contrast, has a flash point of 13 °C and is a Class 3 flammable liquid. Where ethanol is used as a co-solvent for carrier-strip flavour extraction or for surface cleaning at scale, the storage cabinet falls under AS/NZS 60079.10.1 zoning. Inside the cabinet (above the liquid surface) is Zone 1; within 1 m of an open container is Zone 2. The cabinet exhaust runs continuously, classified rated equipment (Ex e or Ex d) is required inside the zone, and the exhaust fan is selected from the appropriate ATEX/IECEx Ex-rated product range.

Bulk PG/VG storage rooms

Bulk drum storage of PG and VG — typical drum sizes are 200 L for VG and 200 L or IBC totes for PG — is governed by NFPA 30 equivalent provisions and the Australian Dangerous Goods Code Class 3 (where present) and Class 9 (where the chemicals are not classified DG but are present in bulk). The storage room is provided with independent exhaust at 6–8 ACH continuous, no recirculation, bunded floors to contain a credible spill, no electrical equipment below 0.5 m elevation from floor, and explosion-relief panels sized to the room volume if any Class 3 inventory is present.

Decanting and weighing

The decanting operation — transferring concentrate from a sealed drum into the compounding work container — is the highest-exposure single activity in the facility. A dedicated decanting booth with face velocity 0.5–1.0 m/s, classified exhaust, and bunded floor handles the operation with operator exposure well below any of the relevant OELs. The decanting booth exhausts to a dedicated extract that joins the main compounding-suite exhaust upstream of the carbon stage.

AS 1668.2 and the Australian ventilation code

The general Australian ventilation code, AS 1668.2 (The Use of Ventilation and Airconditioning in Buildings, Part 2: Mechanical Ventilation in Buildings), applies to all of the supporting spaces around the regulated compounding suite — the dispensary, customer area, staff facilities and storage. AS 1668.2 sets minimum outside-air rates, exhaust requirements for laboratories and kitchens, and prescriptive requirements for separating contaminant-generating spaces from clean spaces.

For a TGA-licensed compounding pharmacy the AS 1668.2 minima are baseline and the TGO 100 / PIC/S requirements are the operative envelope — wherever the two diverge, the pharmaceutical standard governs. The interaction is mostly seamless: AS 1668.2's general dispensary outside-air rate is around 10 L/s/person, which is well exceeded by the 20–30 ACH applied to the compounding suite. The code section relevant for laboratory exhaust applies to the decanting booth and the QC laboratory if present, requiring an independent exhaust system per laboratory zone.

For full background on AS 1668.2 and the broader Australian ventilation code see our companion article AS 1668.2 Australian Ventilation Code Reference.

Tobacco distribution warehouse HVAC — the simpler scope

Tobacco distribution warehouses serve a different engineering problem entirely. There is no GMP requirement, no nicotine handling in concentrate form, no cleanroom envelope. The dominant requirements are climate stability (to protect product shelf life), fire protection (insurance-driven, addressing the combustible nature of stored tobacco product), and dust management (tobacco dust accumulates wherever there is air movement and stored bulk).

Climate control

Cigarette product (including heated tobacco consumables) is sensitive to humidity. Target ranges for warehoused stock are typically 16–20 °C and 45–55% RH. Maintaining humidity within those bands across a 5,000–20,000 m² warehouse volume requires substantial dehumidification capacity. Distribution ductwork for these warehouses uses standard galvanized rectangular with TDF flange — there is no chemistry argument against galvanized in the absence of nicotine concentrate exposure.

Filtration

BAT Australia, Imperial Tobacco Australia and Philip Morris Australia warehouses typically specify F7 prefiltration on outside air to keep settled dust off retail packaging. Internal recirculation does not pass through HEPA — the cost-benefit does not justify it for cigarette and heated-tobacco distribution. Exhaust from the picking floor passes through F7 secondary filtration before atmosphere discharge, primarily to satisfy local council nuisance-emission provisions.

Fire protection interface

Tobacco warehouse fire protection is governed by AS 2118 series (Automatic Fire Sprinkler Systems). The HVAC interface includes fire-rated duct dampers at every wall and floor penetration of a fire compartment, fire-rated duct enclosures where ductwork passes through escape routes, and automated AHU shutdown on fire-alarm activation. Distribution ductwork to picking-floor offices and break rooms must be sealed against smoke migration from the warehouse floor.

Tobacco dust management

Tobacco dust is an under-discussed hygiene issue in distribution warehouses. Cigarette packs and cartons release small amounts of tobacco fines during handling; over time these fines accumulate in supply ductwork, on diffuser faces, and on horizontal surfaces. The HVAC mitigation is straightforward — F7 prefiltration on outside air, easily accessible duct-cleaning ports every 6–8 m on supply runs, and a documented duct-cleaning interval (typically 24 months for distribution warehouse air-handlers).

SBKJ machine configuration for nicotine and pharmaceutical fabrication

The fabrication infrastructure required to produce ductwork to the specification described in this guide is not a generic HVAC duct line. The combination of 316L stainless material, TIG-welded longitudinal seams, pharmaceutical-grade surface roughness and full mill-certificate traceability requires a configured fabrication cell.

SBAL-V vertical auto duct line — stainless configuration

The SBKJ SBAL-V vertical auto duct production line, in its stainless configuration, is the core machine for pharmaceutical and nicotine compounding facility ductwork. The line is configured with stainless-compatible feed rollers, hardened forming tooling sized for 316L work hardening rates, and a TIG longitudinal seam welder mounted inline. Standard material range is 0.8–1.5 mm 316L; on application the line can run up to 2.0 mm for heavier risers and exhaust-stack components.

Key configuration points for nicotine and pharma work:

• Material handling rollers polyurethane-coated to prevent stainless surface marking.
• Forming tooling profile-specific for stainless work-hardening characteristics — different from carbon-steel tooling.
• TIG longitudinal seam welder with argon shielding gas, automated torch travel, real-time arc-voltage monitoring, photographic record of each seam.
• Inline internal weld passivation flush station — citric acid or nitric acid passivation cycle immediately after welding, before the duct leaves the line.
• Surface roughness verification on three sample coupons per batch, recorded against the EN 10204 3.1 material certificate.
• Stainless flange punching and TDF-equivalent stainless flange forming.
• Boroscope inspection station at line end with photographic recording.

TIG seam welder and orbital tube welding

The TIG longitudinal seam welder is the heart of the stainless line. TIG (Gas Tungsten Arc Welding) produces clean, controlled welds with minimal spatter and a smooth surface profile after passivation — the only welding process consistent with pharmaceutical surface roughness targets. The companion orbital tube weld station handles round connecting spools (transitions, bends, transitions to round LAF supply terminals) with the same surface finish and traceability.

For deeper background on welding methods relevant to HVAC duct fabrication and the choice between TIG, MIG, plasma and resistance seam welding see Welding Methods in HVAC Duct Fabrication.

GMP-grade fabrication shop standards

The fabrication shop itself runs under standards aligned with the cleanroom industry's expectations of its suppliers. Welder qualification under AS/NZS 3992 or ISO 9606-1 for stainless welding categories. Material control with EN 10204 3.1 mill certificates for every coil, recorded against the production batch. Surface finish verification on every batch. ATP (adenosine triphosphate) swab sampling on a sample of finished duct interior surface as a pre-shipment hygiene check. Photographic record of every welded joint via boroscope, supplied with the duct in the validation dossier.

For a fuller treatment of the cleanroom duct fabrication workflow and the standards SBKJ runs to for pharmaceutical clients see Cleanroom Duct Manufacturing — Fabrication Standards and Process.

Commissioning and operational qualification

Mechanical commissioning of a TGA-licensed nicotine compounding facility follows the validation-life-cycle structure expected by PIC/S inspectors: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).

Installation qualification

IQ verifies that the as-built installation matches the design. For HVAC and ductwork this means duct routing as-drawn, material certificates traceable to fabricated duct sections, weld inspection records, filter installation records, flow-measurement station installation, pressure-gauge calibration certificates and AHU plant nameplate verification. The IQ document is the foundation of every subsequent audit response.

Operational qualification

OQ tests that the installed system performs to specification. The sequence:

• Duct leak test to EN 1507 Class C or better, demonstrated on each independent duct section before insulation.
• HEPA installation leak test on every supply and exhaust terminal using PAO challenge.
• Air change rate verification by volumetric flow measurement at every supply diffuser and return grille.
• Pressure cascade verification at every door, including dynamic test with door opening cycles.
• Smoke pattern visualization across the LAF workstation and around the operator standing position.
• Recovery time test — challenge the room with a particle generator, then measure the time to return to classification target after particle generation stops. ISO 14644-3 sets the methodology.
• Particle count to ISO 14644-1 — non-viable particle measurement across the room grid, both at-rest and in-operation.

Performance qualification

PQ proves that the system performs over time under real operating conditions. This includes operator-exposure monitoring during a full simulated compounding batch (the breathing-zone nicotine concentration measured against the Safe Work Australia 0.5 mg/m³ TWA), microbial monitoring of supply and return grilles, surface ATP sampling at defined points, and an environmental-monitoring trend report over the first three months of routine operation.

Cross-disciplinary HVAC engineering considerations

A few related engineering interfaces affect the ductwork design and are worth flagging.

Cleanroom envelope integration

The compounding suite envelope is a sealed wall-and-ceiling system, typically modular cleanroom panel construction with welded coving, sealed light fittings, sealed door frames and flush window units. The HVAC interface — supply diffusers, return grilles, exhaust grilles, sensor penetrations — must be designed and installed without compromising the envelope seal. Each penetration is a potential particle ingress path. The standard detail is a powder-coated steel collar welded to the panel face, sealed to the duct with continuous gasket and bolted flange.

For broader pharmaceutical cleanroom HVAC context that overlaps with this nicotine-specific guide see Pharmaceutical and Biotech Cleanroom HVAC Ductwork Guide.

Acoustic performance

Compounding suites operate at noise levels suitable for precision weighing and detailed reading — typically NR 40–45. Achieving this with 20–30 ACH supply is challenging; the supply fan in the AHU must be selected for low specific fan power and the supply ductwork must include silencers immediately downstream of the AHU and immediately upstream of each terminal HEPA box. Stainless lined silencers (mineral-fibre fill encapsulated in stainless mesh) are the standard for compounding-suite supply runs.

Energy and outside air load

A full once-through compounding suite is energy-intensive — 2,250 m³/h of supply air conditioned from outdoor temperature to 18–22 °C and from outdoor humidity to 45–55% RH is a non-trivial load. Many facilities use heat recovery on the exhaust train (cross-plate or run-around coil heat recovery between the exhaust upstream of the carbon stage and the supply intake) to reduce the conditioning load on the AHU. Run-around coil heat recovery is preferred over rotary or plate heat exchangers because it eliminates any possibility of cross-contamination between exhaust and supply.

Building automation system interfaces

The BAS interfaces are extensive: AHU supply and exhaust fan speed control, pressure cascade monitoring at every door, filter loading monitoring, temperature and humidity setpoint control, room particle count interface (where in-line particle monitors are fitted), nicotine breakthrough monitor interface (where chemiresistive nicotine sensors are fitted at the carbon outlet), and integration with the facility access control to log every entry to the compounding suite for the regulatory audit trail.

Cross-references to adjacent SBKJ engineering guides

Nicotine compounding and tobacco distribution sit at the intersection of several engineering domains. The following guides expand on subjects touched on above:

• Medicinal Cannabis Cultivation HVAC Ductwork — Australian ODC Guide — covers the related scheduled-substance regulatory framework, cultivation-room and processing-room ventilation, and the ODC interface from the cultivation side.
• Pharmaceutical and Biotech Cleanroom HVAC Ductwork Guide — broader pharmaceutical cleanroom HVAC engineering for non-sterile and sterile manufacture, ISO 14644 class selection, AHU plant design.
• Cleanroom Duct Manufacturing — Fabrication Standards and Process — the SBKJ fabrication process for cleanroom ductwork: material control, welding qualification, surface finish, pre-handover inspection.
• Welding Methods in HVAC Duct Fabrication — TIG, MIG, plasma, resistance seam welding compared, with detail on TIG procedures for pharmaceutical-grade stainless.
• AS 1668.2 Australian Ventilation Code Reference — the Australian baseline ventilation code, applicable to all supporting spaces around a regulated compounding suite.

How SBKJ supports TGA-licensed and tobacco distribution clients

SBKJ Group's engagement on Australian regulated-product HVAC ductwork typically follows a four-stage path.

Stage 1 — Pre-design technical consultation

Before a single duct section is fabricated, SBKJ engineers review the project brief with the consulting mechanical engineer or the facility owner. The output is a fabrication specification covering material grade, thickness, welding method, surface roughness target, flange type, gasket material, leak-test class, inspection regime and validation-dossier scope. For TGA-licensed compounding pharmacies this consultation is typically free of charge as part of the quotation development.

Stage 2 — Quotation and contract

The quotation is itemised: ducting linear-metre rates by diameter and material, fittings by type, flanges, gaskets, inspection and documentation. Contract terms run on SBKJ's standard commercial framework — 30 percent T/T deposit at order confirmation, 70 percent balance against bill of lading copy or before shipment — with optional Letter of Credit at sight for orders above the contract threshold. Lead times for a typical compounding-pharmacy fit-out scope (60–120 linear metres of 316L ductwork plus fittings) are 6–10 weeks from order to ex-works.

Stage 3 — Fabrication and pre-shipment

Fabrication runs on the SBAL-V stainless line described above, under documented welder qualification and full material traceability. Pre-shipment quality control includes boroscope inspection of every welded joint, surface roughness verification, ATP swab pre-handover, and packaging of all material certificates and inspection records into the validation dossier. The dossier ships with the duct.

Stage 4 — Installation support and commissioning interface

SBKJ's standard installation support covers technical telephone and video consultation with the installing contractor's site team during installation and pre-commissioning leak test. Onsite engineer support is available on request for projects above the contract threshold, typically 1–2 SBKJ engineers for 3–5 days during the duct leak test and HEPA installation phase. Onsite support during the full validation cycle (OQ, PQ) is by separate scope.

Get an itemised SBKJ quote for TGA-compliant 316L ductwork →

FAQ

Why does Australia have no recreational tobacco or nicotine vape manufacturing?

Australia does not host commercial cigarette manufacturing — Philip Morris closed its Moorabbin plant in 2014 and Imperial Tobacco closed its Sydney facility in 2015. All cigarettes sold in Australia are imported. For nicotine vape, since October 2024 the Therapeutic Goods Administration has required prescription-only access through TGA-approved sponsors or pharmacy compounding under the Special Access Scheme. Recreational vape supply is illegal. The only domestic nicotine vape manufacturing therefore occurs in TGA-licensed compounding pharmacies producing patient-specific therapeutic preparations under Therapeutic Goods Order 110.

What ISO 14644 cleanroom class is required for compounded nicotine vape?

TGA Therapeutic Goods Order 100 applies the PIC/S Guide to Good Manufacturing Practice. For non-sterile compounded liquid preparations, Grade D (ISO 14644 Class 8 in operation) is the minimum — typical compounding pharmacy practice is to operate Grade C (ISO Class 7 in operation, Class 8 at rest) for the compounding suite with a Grade B / ISO Class 5 laminar flow workstation over the actual filling operation. Air change rates of 20–30 per hour are typical for Grade C suites in nicotine compounding.

What is the occupational exposure limit for nicotine in Australia?

Safe Work Australia's Workplace Exposure Standards list nicotine (CAS 54-11-5) at a Time Weighted Average of 0.5 mg/m³ over an 8-hour shift, with skin notation due to dermal absorption. Compounding pharmacies handling nicotine concentrate must engineer LEV at the weighing and dilution station sufficient to keep operator breathing-zone concentrations well below this number, typically by maintaining face velocity of 0.4–0.5 m/s at a partial enclosure or 0.5–1.0 m/s at a fume cupboard.

Why is galvanized steel ductwork unsuitable for nicotine vape production rooms?

Two reasons. First, nicotine is a strongly alkaline secondary amine that adsorbs onto zinc oxide surfaces and can re-emit at low rates for months after exposure — that fails the cleanability requirement of TGO 100. Second, propylene glycol and vegetable glycerin are hygroscopic and will hold thin liquid films on cool duct walls; over time these films carry nicotine residue and trace flavour acids that attack the zinc coating, releasing zinc fume and white rust. Production rooms must therefore use 316L stainless steel duct with TIG-welded longitudinal seams, polished interior, and stainless flanges with EPDM or silicone gaskets.

What exhaust treatment is required before discharging compounding-room air to atmosphere?

A typical TGA-compliant compounding pharmacy nicotine suite uses a three-stage exhaust train: prefilter (G4/F7) for particulates, activated carbon canister for nicotine and flavour-compound VOC capture, and HEPA H14 final filter before the roof-mounted exhaust fan and stack. Where ethanol is used as a co-solvent or PG/VG bulk storage exists, the storage zone is separately classified under AS/NZS 60079 (ATEX/IECEx) and discharged through an explosion-relief duct independent of the compounding-room exhaust.

What SBKJ machine configuration is appropriate for TGA-licensed nicotine compounding facility ductwork?

For GMP-grade pharmaceutical fabrication shops supplying nicotine compounding suites, SBKJ supplies the SBAL-V vertical auto duct line configured for 316L stainless steel (0.8–1.5 mm), with TIG longitudinal seam welder, internal weld passivation flush and orbital tube weld station for round connecting spools. The fabrication facility itself runs under documented welder qualification (AS/NZS 3992 or ISO 9606-1), full material traceability with mill certificates, surface roughness verification at Ra ≤ 0.8 µm, and supplier-issued ATP swab pre-handover.