{"id":39,"date":"2026-10-13T02:00:28","date_gmt":"2026-10-13T02:00:28","guid":{"rendered":"https:\/\/fgvhp.com\/vhp-knowledge\/isolator-airflow-visualisation-smoke-study\/"},"modified":"2026-10-13T03:42:58","modified_gmt":"2026-10-13T03:42:58","slug":"isolator-airflow-visualisation-smoke-study","status":"publish","type":"post","link":"https:\/\/fgvhp.com\/es\/vhp-knowledge\/isolator-airflow-visualisation-smoke-study\/","title":{"rendered":"Visualizaci\u00f3n del flujo de aire en aisladores: c\u00f3mo planificar y evaluar un estudio de humo"},"content":{"rendered":"\n\n<section class=\"phero\"><div class=\"wrap\">\n  <div class=\"crumb\"><a href=\"\/\">Home<\/a> \/ <a href=\"\/vhp-knowledge\/\">VHP Knowledge<\/a> \/ <span>Isolators<\/span><\/div>\n  <span class=\"mono eyebrow\">Isolators<\/span>\n  <h1>Isolator Airflow Visualisation: How to Plan and Judge a Smoke Study<\/h1>\n  <p class=\"lead\">A smoke study is the only test that shows how air actually moves over open product in an isolator \u2014 including when an operator reaches in through a glove. This guide covers what EU GMP Annex 1 expects, how to set the study up, what to film, and how to tell a good result from a bad one.<\/p>\n  <div class=\"ameta\"><span>Fenggu VHP engineering team<\/span><span>4 min read<\/span><span>Updated October 2026<\/span><\/div>\n<\/div><\/section>\n\n<section class=\"fgv-sec\" style=\"padding-top:48px\"><div class=\"wrap\"><div class=\"art\">\n  <div class=\"keyp\"><b>Key points<\/b><ul><li>Velocity and particle counts prove the air is clean; only visualisation shows where it goes.<\/li><li>EU GMP Annex 1 (2022) expects airflow patterns in critical zones to be visualised and recorded, at rest and in operation.<\/li><li>Use a residue-free fog (typically from water for injection) rather than chemical smoke inside an aseptic isolator.<\/li><li>Film the interventions, not just the empty isolator: arms through gloves, component loading, transfer port openings.<\/li><li>Good flow sweeps smoothly over and away from open product; eddies, stagnation or backflow over the critical zone are findings.<\/li><\/ul><\/div>\n  \n  <h2>What a smoke study proves<\/h2>\n<p>Air velocity measurements tell you how fast the air leaves the filter. Particle counts tell you how clean it is at the sampling point. Neither shows whether the air that reaches an open vial has just passed over an operator&#8217;s sleeve, a moving part, or the edge of a stopper bowl. Airflow visualisation does \u2014 and that is why regulators treat it as a separate, essential part of qualifying an aseptic barrier.<\/p>\n<p>EU GMP Annex 1 (2022) expects airflow patterns to be visualised to show that air does not move from less clean areas into the critical zone, and that unidirectional airflow protects the product, both at rest and under operating conditions with interventions. The studies should be documented \u2014 in practice that means a video record linked to the study protocol \u2014 and repeated after changes that could affect airflow.<\/p>\n\n<h2>Unidirectional or turbulent?<\/h2>\n<p>Where open product and sterile components are exposed, isolators normally provide unidirectional airflow over the critical zone. Annex 1 gives a guidance range of 0.36\u20130.54 m\/s at the working position for unidirectional airflow systems, unless another value is scientifically justified in the contamination control strategy. Some closed isolators, and transfer chambers, use turbulent (mixed) airflow; there the study shows that air is well mixed and that no part of the chamber is stagnant. The study design follows the design of the isolator.<\/p>\n\n<figure>\n<svg viewBox=\"0 0 760 330\" role=\"img\" aria-label=\"Isolator smoke study: unidirectional airflow over the critical zone, disturbed by an operator arm and an obstruction\" font-family=\"IBM Plex Sans, Arial, sans-serif\">\n  <rect x=\"10\" y=\"10\" width=\"740\" height=\"310\" rx=\"12\" fill=\"#F5F8FB\" stroke=\"#DCE3EC\"\/>\n  <defs><marker id=\"sa\" viewBox=\"0 0 10 10\" refX=\"8\" refY=\"5\" markerWidth=\"6\" markerHeight=\"6\" orient=\"auto\"><path d=\"M0 0 L10 5 L0 10z\" fill=\"#0A8F8A\"\/><\/marker>\n  <marker id=\"sr\" viewBox=\"0 0 10 10\" refX=\"8\" refY=\"5\" markerWidth=\"6\" markerHeight=\"6\" orient=\"auto\"><path d=\"M0 0 L10 5 L0 10z\" fill=\"#D62B2B\"\/><\/marker><\/defs>\n  <g font-size=\"13\" font-weight=\"700\" fill=\"#0E1A2B\"><text x=\"30\" y=\"40\">Good: smooth sweep over open product<\/text><text x=\"400\" y=\"40\">Finding: arm and obstruction disturb the flow<\/text><\/g>\n  <rect x=\"30\" y=\"55\" width=\"330\" height=\"240\" rx=\"6\" fill=\"#fff\" stroke=\"#5A6B82\" stroke-width=\"2\"\/>\n  <rect x=\"40\" y=\"62\" width=\"310\" height=\"14\" fill=\"#C9D3DF\"\/><text x=\"195\" y=\"73\" font-size=\"10\" fill=\"#2B3A4F\" text-anchor=\"middle\">HEPA \u00b7 unidirectional<\/text>\n  <g stroke=\"#0A8F8A\" stroke-width=\"1.8\" fill=\"none\" marker-end=\"url(#sa)\"><path d=\"M80 82 V230 Q80 262 60 272\"\/><path d=\"M140 82 V230 Q140 262 120 272\"\/><path d=\"M200 82 V200\"\/><path d=\"M260 82 V230 Q260 262 280 272\"\/><path d=\"M320 82 V230 Q320 262 340 272\"\/><\/g>\n  <g fill=\"#fff\" stroke=\"#2B3A4F\"><rect x=\"170\" y=\"212\" width=\"12\" height=\"22\"\/><rect x=\"188\" y=\"212\" width=\"12\" height=\"22\"\/><rect x=\"206\" y=\"212\" width=\"12\" height=\"22\"\/><rect x=\"224\" y=\"212\" width=\"12\" height=\"22\"\/><\/g>\n  <rect x=\"60\" y=\"234\" width=\"290\" height=\"8\" fill=\"#C9D3DF\"\/>\n  <text x=\"195\" y=\"285\" font-size=\"11\" fill=\"#5A6B82\" text-anchor=\"middle\">air reaches containers first, then leaves low<\/text>\n  <rect x=\"400\" y=\"55\" width=\"330\" height=\"240\" rx=\"6\" fill=\"#fff\" stroke=\"#5A6B82\" stroke-width=\"2\"\/>\n  <rect x=\"410\" y=\"62\" width=\"310\" height=\"14\" fill=\"#C9D3DF\"\/><text x=\"565\" y=\"73\" font-size=\"10\" fill=\"#2B3A4F\" text-anchor=\"middle\">HEPA \u00b7 unidirectional<\/text>\n  <circle cx=\"400\" cy=\"160\" r=\"18\" fill=\"#E6EDF4\" stroke=\"#5A6B82\" stroke-width=\"2\"\/>\n  <path d=\"M400 150 C450 145 500 150 535 165 L540 178 C500 168 450 166 400 172 Z\" fill=\"#E9DFC9\" stroke=\"#B49A63\"\/>\n  <g stroke=\"#0A8F8A\" stroke-width=\"1.8\" fill=\"none\" marker-end=\"url(#sa)\"><path d=\"M450 82 V138\"\/><path d=\"M640 82 V200\"\/><path d=\"M700 82 V230 Q700 262 720 272\"\/><\/g>\n  <path d=\"M515 82 V140 C515 150 535 150 550 172 C560 190 545 205 530 198 C515 190 525 175 540 182\" fill=\"none\" stroke=\"#D62B2B\" stroke-width=\"1.8\" marker-end=\"url(#sr)\"\/>\n  <rect x=\"600\" y=\"160\" width=\"40\" height=\"40\" rx=\"4\" fill=\"#C9D3DF\"\/>\n  <path d=\"M620 150 C600 135 590 160 605 168\" fill=\"none\" stroke=\"#D62B2B\" stroke-width=\"1.8\" stroke-dasharray=\"3 3\" marker-end=\"url(#sr)\"\/>\n  <g fill=\"#fff\" stroke=\"#2B3A4F\"><rect x=\"540\" y=\"212\" width=\"12\" height=\"22\"\/><rect x=\"558\" y=\"212\" width=\"12\" height=\"22\"\/><rect x=\"576\" y=\"212\" width=\"12\" height=\"22\"\/><\/g>\n  <rect x=\"430\" y=\"234\" width=\"290\" height=\"8\" fill=\"#C9D3DF\"\/>\n  <text x=\"565\" y=\"262\" font-size=\"11\" fill=\"#D62B2B\" text-anchor=\"middle\">air passes over the sleeve, then the containers;<\/text>\n  <text x=\"565\" y=\"278\" font-size=\"11\" fill=\"#D62B2B\" text-anchor=\"middle\">eddy behind the obstruction<\/text>\n<\/svg>\n<figcaption>Schematic. The same isolator can show clean, sweeping flow at rest and unacceptable flow during an intervention \u2014 which is why interventions must be filmed.<\/figcaption>\n<\/figure>\n\n<h2>Planning the study<\/h2>\n<table>\n<thead><tr><th>Decision<\/th><th>Practical approach<\/th><\/tr><\/thead>\n<tbody>\n<tr><th>Fog source<\/th><td>Inside an aseptic isolator, use a fog generator producing fine droplets of water for injection or ultrapure water. It is visible, neutral in buoyancy and leaves no residue. Chemical smoke and glycol fogs leave residues and are better kept out of aseptic equipment.<\/td><\/tr>\n<tr><th>Introduction point<\/th><td>Release fog gently just below the filter face or at the point being studied, at low velocity, so the fog follows the air rather than its own jet. A wand or perforated tube lets you release it across the whole width.<\/td><\/tr>\n<tr><th>Lighting and background<\/th><td>A dark, matte background and a light sheet or strong side lighting make the fog visible. Glass and stainless steel reflect; plan camera angles that avoid glare.<\/td><\/tr>\n<tr><th>Camera<\/th><td>Fixed camera positions that show the critical zone from the front and the side, plus close-ups. Record the time, the conditions and the activity on screen or in a log, so each clip can be linked to the protocol.<\/td><\/tr>\n<tr><th>Conditions<\/th><td>At rest (equipment running, no operator activity) and in operation (machine running at production speed with interventions).<\/td><\/tr>\n<tr><th>Interventions<\/th><td>Every routine (inherent) intervention and each foreseeable corrective intervention: loading stoppers, clearing a fallen vial, adjusting a guide, taking an EM sample, connecting a transfer port.<\/td><\/tr>\n<\/tbody>\n<\/table>\n\n<h2>What to look for<\/h2>\n<p>A study passes when the fog shows that air over open product and sterile surfaces is first air \u2014 it comes straight from the filter \u2014 and leaves the critical zone without returning. In practice:<\/p>\n<ul>\n<li><strong>Smooth, parallel flow<\/strong> from the filter down over the containers, needles and stopper track.<\/li>\n<li><strong>No eddies or stagnation<\/strong> over the critical zone; fog released there clears within seconds.<\/li>\n<li><strong>No air passing over the operator&#8217;s sleeve or glove<\/strong> before it reaches open product. Interventions are designed so the arm is downstream of the product, or the product is protected while the arm is in the zone.<\/li>\n<li><strong>No reflux<\/strong> from lower-grade areas \u2014 for example through a mousehole or an opened transfer port \u2014 into the critical zone.<\/li>\n<li><strong>Return paths clear.<\/strong> Air leaves through the low-level returns as designed; the returns are not blocked by equipment or components.<\/li>\n<\/ul>\n\n<h2>Common findings and fixes<\/h2>\n<table>\n<thead><tr><th>Finding<\/th><th>Typical fix<\/th><\/tr><\/thead>\n<tbody>\n<tr><th>Eddy behind a guard, a sensor or the stopper bowl<\/th><td>Reposition or reshape the part, perforate the guard, or move the containers out of its wake.<\/td><\/tr>\n<tr><th>Air passes over the glove before the product<\/th><td>Change the glove port position or the intervention method; use tools that keep the hand downstream; stop the line during the intervention.<\/td><\/tr>\n<tr><th>Turbulence where flow meets a flat surface<\/th><td>Perforated work surfaces or a gap that lets air pass through and down to the returns.<\/td><\/tr>\n<tr><th>Outflow at a mousehole reverses during machine movement<\/th><td>Review the pressure differential and the exhaust balance; check behaviour with doors opening in the room.<\/td><\/tr>\n<tr><th>Slow clearance in a transfer chamber<\/th><td>Increase the air change rate or move the inlet and outlet to remove dead corners.<\/td><\/tr>\n<\/tbody>\n<\/table>\n\n<h2>When to repeat it<\/h2>\n<p>Repeat the study after any change that could affect airflow: new format parts, moved equipment, changed fan settings, new interventions or a modified glove port layout. It is also good practice to include airflow visualisation in periodic requalification. Because smoke studies are a training tool as well as a qualification test, many sites show the videos to every operator who works at the isolator.<\/p>\n<p>Smoke studies complement the other barrier tests: the chamber <a href=\"https:\/\/fenggu-bio.com\/isolator-leak-test-pressure-decay\/\" target=\"_blank\" rel=\"noopener\">leak test<\/a>, <a href=\"\/vhp-knowledge\/isolator-glove-integrity-testing\/\">glove integrity testing<\/a> and the HEPA filter integrity test carried out at <a href=\"\/vhp-knowledge\/isolator-fat-sat-checklist\/\">FAT and SAT<\/a>.<\/p>\n  \n  <div class=\"refs\"><p><b>References<\/b><\/p><p>EU GMP Annex 1 (2022), Manufacture of Sterile Medicinal Products<\/p><p>ISO 14644-3, Cleanrooms \u2014 Test methods (airflow direction test and visualisation)<\/p><p>ISO 13408-6, Aseptic processing of health care products \u2014 Isolator systems<\/p><p>PDA Technical Report No. 34, Design and Validation of Isolator Systems<\/p><\/div>\n<\/div><\/div><\/section>\n\n<section class=\"fgv-sec alt\"><div class=\"wrap\">\n  <span class=\"mono eyebrow\">Equipment<\/span><h2>Fenggu equipment for this<\/h2>\n  <div class=\"opts\"><a class=\"opt\" href=\"https:\/\/fenggu-bio.com\/products\/aseptic-filling-isolator\/\" target=\"_blank\" rel=\"noopener\"><span class=\"mono\">FG-ISO-AF<\/span><h3>Aseptic filling isolator<\/h3><p>Integrated VHP bio-decontaminates exposed interior surfaces before every campaign; unidirectional airflow, H14 HEPA, pressure and particle monitoring.<\/p><span class=\"go\">View specifications \u2192<\/span><\/a><a class=\"opt\" href=\"https:\/\/fenggu-bio.com\/products\/sterility-test-isolator\/\" target=\"_blank\" rel=\"noopener\"><span class=\"mono\">FG-ISO-ST<\/span><h3>Sterility test isolator<\/h3><p>Reserved VHP generator port to decontaminate the chamber and exposed surfaces before testing, reducing false positives.<\/p><span class=\"go\">View specifications \u2192<\/span><\/a><a class=\"opt\" href=\"https:\/\/fenggu-bio.com\/products\/cell-processing-isolator\/\" target=\"_blank\" rel=\"noopener\"><span class=\"mono\">FG-ISO-CC<\/span><h3>Cell processing isolator<\/h3><p>Dry VHP decontamination between processes, with temperature control during the cycle to protect cell viability.<\/p><span class=\"go\">View specifications \u2192<\/span><\/a><\/div>\n  <p style=\"margin-top:24px\">Related application guides: <a class=\"go\" href=\"\/applications\/isolator-rabs-decontamination\/\">Isolator and RABS decontamination<\/a> \u00b7 <a class=\"go\" href=\"\/applications\/cell-gene-therapy\/\">Cell and gene therapy<\/a><\/p>\n<\/div><\/section>\n\n<section class=\"fgv-sec\"><div class=\"wrap narrow\">\n  <span class=\"mono eyebrow\">FAQ<\/span><h2>Common questions<\/h2>\n  <div class=\"faq\"><details><summary>Is a smoke study required for an isolator?<\/summary><p>EU GMP Annex 1 (2022) expects airflow patterns in critical zones to be visualised and documented, at rest and in operation, to show that air does not move from less clean areas into the critical zone. For aseptic isolators this is done with a smoke or fog study.<\/p><\/details><details><summary>What fog should be used in an aseptic isolator?<\/summary><p>A fog of fine droplets of water for injection or ultrapure water from a fog generator. It is clearly visible, follows the air and leaves no residue. Chemical smokes and glycol fogs leave residues on surfaces.<\/p><\/details><details><summary>What air velocity is expected in an isolator?<\/summary><p>For unidirectional airflow, Annex 1 gives a guidance range of 0.36\u20130.54 m\/s at the working position, unless another value is justified in the contamination control strategy. The smoke study shows whether that air actually protects the product.<\/p><\/details><details><summary>Which interventions should be included in a smoke study?<\/summary><p>All routine interventions and every foreseeable corrective intervention, such as loading components, clearing fallen containers, adjusting guides, environmental monitoring and connecting transfer ports.<\/p><\/details><details><summary>When should an isolator smoke study be repeated?<\/summary><p>After any change that could affect airflow \u2014 new format parts, moved equipment, changed fan settings or new interventions \u2014 and as part of periodic requalification.<\/p><\/details><\/div>\n<\/div><\/section>\n<script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Is a smoke study required for an isolator?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"EU GMP Annex 1 (2022) expects airflow patterns in critical zones to be visualised and documented, at rest and in operation, to show that air does not move from less clean areas into the critical zone. 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