{"id":27,"date":"2026-10-12T14:27:58","date_gmt":"2026-10-12T14:27:58","guid":{"rendered":"https:\/\/fgvhp.com\/vhp-knowledge\/isolator-fat-sat-checklist\/"},"modified":"2026-10-13T03:42:58","modified_gmt":"2026-10-13T03:42:58","slug":"isolator-fat-sat-checklist","status":"publish","type":"post","link":"https:\/\/fgvhp.com\/ar\/vhp-knowledge\/isolator-fat-sat-checklist\/","title":{"rendered":"\u0627\u062e\u062a\u0628\u0627\u0631\u0627\u062a FAT \u0648SAT \u0644\u062c\u0647\u0627\u0632 \u0627\u0644\u0639\u0632\u0644: \u0645\u0627 \u064a\u062c\u0628 \u0641\u062d\u0635\u0647 \u0642\u0628\u0644 \u0627\u0644\u0634\u062d\u0646 \u0648\u0641\u064a \u0627\u0644\u0645\u0648\u0642\u0639"},"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 FAT and SAT: What to Check Before Shipment and on Site<\/h1>\n  <p class=\"lead\">The factory acceptance test is the last chance to find problems while the isolator is still in the manufacturer&#8217;s workshop, where fixing them is quick and cheap. This guide sets out what an isolator FAT and SAT should cover, how they connect to qualification, and a practical checklist you can adapt.<\/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>FAT proves the isolator meets the URS before it leaves the factory; SAT proves it still does after transport and installation.<\/li><li>Agree the FAT protocol and acceptance criteria in advance, traced to URS requirements.<\/li><li>Test what can break or drift in transport again at SAT: leak rate, HEPA integrity, airflow, sensors and interlocks.<\/li><li>Well-documented FAT results can be leveraged in IQ\/OQ, which shortens site work \u2014 if the test conditions are representative.<\/li><li>Bring the people who will run the isolator to the FAT: ergonomics and operating problems are cheapest to fix there.<\/li><\/ul><\/div>\n  \n  <h2>Where FAT and SAT fit<\/h2>\n<p>An isolator project moves from requirements to a qualified, working system through a chain of documents and tests. Factory acceptance (FAT) and site acceptance (SAT) are the two commissioning tests that sit between design and formal qualification.<\/p>\n<figure>\n<svg viewBox=\"0 0 760 200\" role=\"img\" aria-label=\"Isolator project sequence from URS through design, FAT, shipping, installation, SAT, IQ\/OQ and PQ\" font-family=\"IBM Plex Sans, Arial, sans-serif\">\n  <rect x=\"10\" y=\"10\" width=\"740\" height=\"180\" rx=\"12\" fill=\"#F5F8FB\" stroke=\"#DCE3EC\"\/>\n  <defs><marker id=\"fa\" viewBox=\"0 0 10 10\" refX=\"8\" refY=\"5\" markerWidth=\"6\" markerHeight=\"6\" orient=\"auto\"><path d=\"M0 0 L10 5 L0 10z\" fill=\"#5A6B82\"\/><\/marker><\/defs>\n  <g font-size=\"12\" text-anchor=\"middle\">\n    <rect x=\"25\" y=\"70\" width=\"70\" height=\"50\" rx=\"6\" fill=\"#FFFFFF\" stroke=\"#C9D3DF\"\/><text x=\"60\" y=\"99\" fill=\"#0E1A2B\">URS<\/text>\n    <rect x=\"115\" y=\"70\" width=\"80\" height=\"50\" rx=\"6\" fill=\"#FFFFFF\" stroke=\"#C9D3DF\"\/><text x=\"155\" y=\"92\" fill=\"#0E1A2B\">Design<\/text><text x=\"155\" y=\"108\" fill=\"#5A6B82\" font-size=\"11\">DQ \/ review<\/text>\n    <rect x=\"215\" y=\"62\" width=\"90\" height=\"66\" rx=\"6\" fill=\"#0A8F8A\"\/><text x=\"260\" y=\"92\" fill=\"#FFFFFF\" font-weight=\"700\">FAT<\/text><text x=\"260\" y=\"110\" fill=\"#FFFFFF\" font-size=\"11\">at factory<\/text>\n    <rect x=\"325\" y=\"70\" width=\"80\" height=\"50\" rx=\"6\" fill=\"#FFFFFF\" stroke=\"#C9D3DF\"\/><text x=\"365\" y=\"92\" fill=\"#0E1A2B\">Pack &amp;<\/text><text x=\"365\" y=\"108\" fill=\"#0E1A2B\">ship<\/text>\n    <rect x=\"425\" y=\"70\" width=\"80\" height=\"50\" rx=\"6\" fill=\"#FFFFFF\" stroke=\"#C9D3DF\"\/><text x=\"465\" y=\"99\" fill=\"#0E1A2B\">Install<\/text>\n    <rect x=\"525\" y=\"62\" width=\"90\" height=\"66\" rx=\"6\" fill=\"#0A8F8A\"\/><text x=\"570\" y=\"92\" fill=\"#FFFFFF\" font-weight=\"700\">SAT<\/text><text x=\"570\" y=\"110\" fill=\"#FFFFFF\" font-size=\"11\">on site<\/text>\n    <rect x=\"635\" y=\"70\" width=\"100\" height=\"50\" rx=\"6\" fill=\"#FFFFFF\" stroke=\"#C9D3DF\"\/><text x=\"685\" y=\"92\" fill=\"#0E1A2B\">IQ \/ OQ \/ PQ<\/text><text x=\"685\" y=\"108\" fill=\"#5A6B82\" font-size=\"11\">incl. BI cycles<\/text>\n  <\/g>\n  <g stroke=\"#5A6B82\" stroke-width=\"1.5\" marker-end=\"url(#fa)\"><line x1=\"95\" y1=\"95\" x2=\"113\" y2=\"95\"\/><line x1=\"195\" y1=\"95\" x2=\"213\" y2=\"95\"\/><line x1=\"305\" y1=\"95\" x2=\"323\" y2=\"95\"\/><line x1=\"405\" y1=\"95\" x2=\"423\" y2=\"95\"\/><line x1=\"505\" y1=\"95\" x2=\"523\" y2=\"95\"\/><line x1=\"615\" y1=\"95\" x2=\"633\" y2=\"95\"\/><\/g>\n  <text x=\"380\" y=\"160\" font-size=\"12\" fill=\"#5A6B82\" text-anchor=\"middle\">Results from FAT and SAT can be referenced in IQ\/OQ when conditions are representative and documented.<\/text>\n<\/svg>\n<figcaption>FAT and SAT are commissioning tests; formal qualification follows, and can build on them.<\/figcaption>\n<\/figure>\n<ul>\n<li><strong>FAT<\/strong> is carried out at the manufacturer, with the isolator fully assembled and running on temporary utilities. It verifies that what was built matches the approved design and the URS.<\/li>\n<li><strong>SAT<\/strong> is carried out after installation at the user&#8217;s site, connected to the real utilities and building. It verifies that nothing was damaged or changed in transport and that the isolator works in its final environment.<\/li>\n<\/ul>\n<p>EU GMP Annex 15 allows FAT results to be used in qualification if it is shown that the function is not affected by transport and installation. Done properly, this avoids repeating long tests on site.<\/p>\n\n<h2>Before the FAT<\/h2>\n<ul>\n<li><strong>Protocol approved in advance.<\/strong> Each test traced to a URS requirement, with method, instrument and acceptance criterion stated.<\/li>\n<li><strong>Calibrated instruments.<\/strong> Certificates for particle counters, anemometers, pressure and H\u2082O\u2082 sensors, and the leak test instrument.<\/li>\n<li><strong>Documents ready for review.<\/strong> Drawings, P&amp;IDs, material certificates, weld records, filter certificates, software design and the draft manuals.<\/li>\n<li><strong>The right people.<\/strong> QA and validation, and also operators and maintenance staff. A mock-up review of glove port positions and reach can be done earlier, but FAT is where everyone sees the real machine.<\/li>\n<\/ul>\n\n<h2>Isolator FAT checklist<\/h2>\n<p>Adapt the list to the isolator type and the URS. Acceptance criteria come from the URS and the applicable standards.<\/p>\n<table>\n<thead><tr><th>Area<\/th><th>What to check<\/th><\/tr><\/thead>\n<tbody>\n<tr><th>Documentation<\/th><td>As-built drawings match the isolator \u00b7 material certificates (e.g. 316L) \u00b7 surface finish records \u00b7 weld documentation \u00b7 component and filter certificates \u00b7 software version recorded<\/td><\/tr>\n<tr><th>Construction<\/th><td>Dimensions and layout \u00b7 surface finish and cleanability, no crevices or dead legs \u00b7 window and gasket fitting \u00b7 glove ports, sleeves and gloves as specified \u00b7 drains and sampling ports<\/td><\/tr>\n<tr><th>Leak tightness<\/th><td>Whole-isolator leak test by pressure decay, result against the specified class (for example ISO 10648-2) \u00b7 door and transfer port seals \u00b7 see <a href=\"https:\/\/fenggu-bio.com\/isolator-leak-test-pressure-decay\/\" target=\"_blank\" rel=\"noopener\">isolator leak testing<\/a><\/td><\/tr>\n<tr><th>Pressure control<\/th><td>Set point reached and held in each operating mode \u00b7 response to glove withdrawal and door operation \u00b7 alarm and recovery \u00b7 see <a href=\"https:\/\/fenggu-bio.com\/isolator-hvac-operating-modes\/\" target=\"_blank\" rel=\"noopener\">isolator HVAC operating modes<\/a><\/td><\/tr>\n<tr><th>Airflow<\/th><td>Air velocity and uniformity at working height for unidirectional zones \u00b7 airflow visualisation (smoke) of critical zones \u00b7 air change rate in transfer chambers<\/td><\/tr>\n<tr><th>Filters<\/th><td>HEPA filter installation integrity scan test \u00b7 filter pressure-drop monitoring<\/td><\/tr>\n<tr><th>Particles<\/th><td>Non-viable particle counts at rest against Grade A (or the specified class)<\/td><\/tr>\n<tr><th>Controls<\/th><td>Every HMI screen and function \u00b7 user levels and passwords \u00b7 audit trail and data records where required \u00b7 recipe handling \u00b7 printouts or exports<\/td><\/tr>\n<tr><th>Interlocks and alarms<\/th><td>Door interlocks, transfer sequence, simulated alarms (pressure, airflow, filter, H\u2082O\u2082, door) and the system response to each<\/td><\/tr>\n<tr><th>Power and utility failure<\/th><td>Behaviour on power loss and recovery \u00b7 loss of compressed air \u00b7 safe state and data retention<\/td><\/tr>\n<tr><th>VHP cycle<\/th><td>Complete cycle run: conditioning, gassing, dwell and aeration \u00b7 concentration, humidity and temperature trends \u00b7 chemical indicators for distribution \u00b7 aeration to the specified level and time<\/td><\/tr>\n<tr><th>Ergonomics<\/th><td>Operators perform real tasks through the gloves: reach, visibility, component handling, cleaning access<\/td><\/tr>\n<\/tbody>\n<\/table>\n<p>Record every deviation in a punch list, agree which must be closed before shipment and which can be closed on site, and sign off the FAT report with that list attached.<\/p>\n\n<h2>Packing and shipping<\/h2>\n<p>Transport is where an isolator that passed FAT can be damaged. Check that the packing protects windows and glove ports, that loose parts are labelled against the packing list, that moisture protection is adequate for sea freight, and that shock and tilt indicators are fitted. Note the condition of indicators and packaging on arrival before signing for delivery.<\/p>\n\n<h2>SAT: what to repeat on site<\/h2>\n<table>\n<thead><tr><th>Test<\/th><th>Why it is repeated<\/th><\/tr><\/thead>\n<tbody>\n<tr><th>Visual inspection and as-installed check<\/th><td>Transport damage, correct position, levelling, connections<\/td><\/tr>\n<tr><th>Utility connections<\/th><td>Real power, compressed air, exhaust and room conditions replace temporary ones<\/td><\/tr>\n<tr><th>Leak test<\/th><td>Seals and joints can move in transport<\/td><\/tr>\n<tr><th>HEPA integrity and airflow<\/th><td>Filters and seals can be disturbed; the room environment affects airflow<\/td><\/tr>\n<tr><th>Sensors and interlocks<\/th><td>Confirm calibration status and function after transport<\/td><\/tr>\n<tr><th>Pressure control in the room<\/th><td>Isolator performance depends on the room pressure and exhaust system<\/td><\/tr>\n<tr><th>VHP cycle<\/th><td>Run in the final environment; the basis for cycle development and the biological indicator studies of PQ<\/td><\/tr>\n<\/tbody>\n<\/table>\n\n<h2>After SAT<\/h2>\n<p>With SAT complete, formal IQ and OQ confirm and document installation and operation, referencing FAT and SAT results where justified. PQ then follows, including VHP cycle qualification with biological indicators \u2014 see <a href=\"https:\/\/fenggu-bio.com\/vhp-validation-biological-indicators\/\" target=\"_blank\" rel=\"noopener\">VHP validation and biological indicators<\/a> on our main site.<\/p>\n  <figure class=\"photo\"><img decoding=\"async\" src=\"\/wp-content\/uploads\/site\/cell-processing-isolator-01.jpg\" alt=\"Fenggu cell processing isolator\" loading=\"lazy\" style=\"max-height:380px;object-fit:contain;padding:20px 0;background:#fff\"><figcaption>Fenggu cell processing isolator. The FAT is the last opportunity to test an isolator while it is still in the factory.<\/figcaption><\/figure>\n  <div class=\"refs\"><p><b>References<\/b><\/p><p>EU GMP Annex 15, Qualification and Validation<\/p><p>EU GMP Annex 1 (2022), Manufacture of Sterile Medicinal Products<\/p><p>ISO 10648-2, Containment enclosures \u2014 Classification according to leak tightness<\/p><p>ISO 14644-3, Cleanrooms \u2014 Test methods<\/p><p>ISPE Baseline Guide Vol. 5: Commissioning and Qualification<\/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\/negative-pressure-isolator\/\" target=\"_blank\" rel=\"noopener\"><span class=\"mono\">FG-ISO-CN<\/span><h3>Negative pressure isolator<\/h3><p>For hazardous materials, where leak tightness and pressure control are central FAT tests.<\/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>What is the difference between FAT and SAT for an isolator?<\/summary><p>FAT is carried out at the manufacturer before shipment and verifies the isolator against the design and URS. SAT is carried out after installation at the user&#8217;s site and confirms that it still meets requirements with real utilities and after transport.<\/p><\/details><details><summary>What should an isolator FAT include?<\/summary><p>Document review, construction checks, a leak test, pressure control, airflow and HEPA integrity, particle counts at rest, HMI and control functions, interlocks and alarms, power failure behaviour, a full VHP cycle and an ergonomics check with operators.<\/p><\/details><details><summary>Can FAT results be used in qualification?<\/summary><p>Yes. EU GMP Annex 15 allows FAT results to be used in qualification if it is shown that the tested functions are not affected by transport and installation, and the tests were properly documented.<\/p><\/details><details><summary>Which tests should be repeated at SAT?<\/summary><p>Those that can be affected by transport or the site environment: visual inspection, utility connections, leak test, HEPA integrity and airflow, sensors and interlocks, pressure control and the VHP cycle.<\/p><\/details><details><summary>Who should attend an isolator FAT?<\/summary><p>QA and validation staff, engineering, and the operators and maintenance staff who will work with the isolator. Problems with reach, visibility and handling are much cheaper to correct at the factory.<\/p><\/details><\/div>\n<\/div><\/section>\n<script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"What is the difference between FAT and SAT for an isolator?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"FAT is carried out at the manufacturer before shipment and verifies the isolator against the design and URS. 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Problems with reach, visibility and handling are much cheaper to correct at the factory.\"}}]}<\/script>\n\n<section class=\"fgv-sec\" style=\"padding-top:0\"><div class=\"wrap\"><div class=\"cta\">\n  <div><span class=\"mono eyebrow\">Free application review<\/span><h2>Have a specific space or load in mind?<\/h2><p>Send the volume, the materials and what you need to prove. 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