{"id":6033,"date":"2026-10-23T12:02:29","date_gmt":"2026-10-23T12:02:29","guid":{"rendered":"https:\/\/www.asm-indus.com\/?post_type=realisations&#038;p=6033"},"modified":"2026-10-30T13:38:23","modified_gmt":"2026-10-30T13:38:23","slug":"machines-speciales-en-salle-blanche-iso-7-8","status":"publish","type":"realisations","link":"https:\/\/www.asm-indus.com\/en\/realisations\/machines-speciales-en-salle-blanche-iso-7-8\/","title":{"rendered":"Special Machines in ISO 7\/8 Cleanrooms"},"content":{"rendered":"<p class=\"wp-block-paragraph\">ASM and its subsidiary HighTaiX design and manufacture custom production equipment for the biotechnology, healthcare, and medical device industries. Cleanliness, traceability, validation, and hygiene: these environments impose requirements that standard machines rarely meet. Our expertise lies in designing specialized machines that integrate these requirements from the initial design phase, from needs assessment to on-site qualification.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Specific constraints, a dedicated design<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Manufacturing in a biotech or pharmaceutical environment means dealing with:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>controlling particulate contamination<\/li>\n\n\n\n<li>compliance with Good Manufacturing Practices (GMP) and documentary traceability<\/li>\n\n\n\n<li>equipment that is qualified and validated before being put into production<\/li>\n\n\n\n<li>frequent cleaning and disinfection<\/li>\n\n\n\n<li>materials compatible with the product and cleaning agents<\/li>\n\n\n\n<li>multi-reference productions, with regular format changes<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">At ASM, each of these constraints is treated as a design requirement, not as a last-minute adaptation.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Cleanroom: ISO 7 and ISO 8 compliant equipment<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Air cleanliness is classified according to ISO 14644-1, which sets a maximum number of particles per cubic meter for each class. ISO classes 7 and 8 correspond, at rest, to grades C and D of GMP.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>ISO Class<\/th><th>GMP grade (at rest)<\/th><th>Particles \u2265 0.5 \u00b5m \/ m\u00b3<\/th><th>Particles \u2265 5 \u00b5m \/ m\u00b3<\/th><\/tr><\/thead><tbody><tr><td>ISO 7<\/td><td>C<\/td><td>352 000<\/td><td>2 930<\/td><\/tr><tr><td>ISO 8<\/td><td>D<\/td><td>3 520 000<\/td><td>29 300<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">The room&#039;s style is dictated by its surroundings: the machine must therefore blend in without disrupting the atmosphere. We design our equipment with this in mind:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Limiting particle generation: selection of appropriate materials, guidance systems and motors, enclosure or relocation of emitting components, and extraction at the source if necessary.<\/li>\n\n\n\n<li>Smooth surfaces and uncluttered shapes, without areas where dust can accumulate.<\/li>\n\n\n\n<li>structure and casings compatible with the room&#039;s airflow<\/li>\n\n\n\n<li>Modular design: machines that can be disassembled and are sized to pass through airlocks<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The target class is defined with you, according to the application and the operation performed. Find our machines for medical devices on the <a href=\"https:\/\/www.asm-indus.com\/en\/realisations\/machine-dassemblage-automatique-de-dispositifs-medicaux\/\" data-type=\"link\" data-id=\"https:\/\/www.asm-indus.com\/realisations\/machine-dassemblage-automatique-de-dispositifs-medicaux\/\">syringe assembly machine<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Design and manufacturing according to cGMP (Good Manufacturing Practices)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Good Manufacturing Practices (GMP), or cGMP, are based on a documented and traceable approach. We apply it to every project:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>User Requirements Specification (URS) analysis and design review<\/li>\n\n\n\n<li>risk analysis<\/li>\n\n\n\n<li>traceability of components and materials<\/li>\n\n\n\n<li>Structured documentation: plans, electrical and pneumatic diagrams, instruction manual, technical file<\/li>\n\n\n\n<li>Automation designed for data reliability: access rights management, time-stamped alarms and events, recipe backup<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Depending on your standard (GMP for medicines, ISO 13485 for medical devices), we adapt the level of documentation and formality.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Qualification and validation: FAT, SAT, IQ, QO<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Equipment intended for a regulated environment must demonstrate that it performs as designed. We prepare and execute the protocols with you:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>FAT (factory acceptance tests)<\/strong> : carried out at ASM before delivery, based on a protocol validated with you.<\/li>\n\n\n\n<li><strong>SAT (on-site acceptance tests)<\/strong> : carried out after installation, to verify that the equipment is delivered in the condition noted at the factory.<\/li>\n\n\n\n<li><strong>IQ (installation qualification)<\/strong> : verification that the installation corresponds to the design and specifications, with the associated documentation and certificates.<\/li>\n\n\n\n<li><strong>QO (operational qualification)<\/strong> : verification of the equipment&#039;s operation within its defined operating ranges.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">A rigorous Factory Acceptance Test (FAT) simplifies and accelerates on-site testing, thus shortening the time to market. Performance qualification (PQ), performed with the product under production conditions, is conducted with the user, based on our results. We apply this approach to our equipment for the medical sector, for example... <a href=\"https:\/\/www.asm-indus.com\/en\/realisations\/machine-dassemblage-automatique-a-plateau-rotatif\/\" data-type=\"link\" data-id=\"https:\/\/www.asm-indus.com\/realisations\/machine-dassemblage-automatique-a-plateau-rotatif\/\">Rotary Table Assembly Machine<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Hygienic design: easy to clean, minimizes risks<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A clean machine is first and foremost a machine that is easy to clean. Our equipment incorporates:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>smooth surfaces, rounded corners and neat welds<\/li>\n\n\n\n<li>the absence of retention areas, nooks and crannies, and unnecessary horizontal surfaces<\/li>\n\n\n\n<li>casings and covers designed for cleaning, and removable when access requires it<\/li>\n\n\n\n<li>coatings and materials that do not flake off<\/li>\n\n\n\n<li>components and lubricants adapted to the environment<\/li>\n\n\n\n<li>compatibility with the cleaning and disinfection agents on your site<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">316L stainless steel and materials suitable for product contact<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">For parts in contact with the product, we favor 316L stainless steel, known for its corrosion resistance, including against cleaning and disinfecting agents, and for its excellent weldability. Other materials (polymers, elastomers, anodized aluminum) are selected based on their compatibility with the product, the process, and the cleanliness of the environment. Material certificates are included in the equipment documentation. This is the case for our <a href=\"https:\/\/www.asm-indus.com\/en\/realisations\/four-a-infrarouge-pour-le-medical\/\" data-type=\"realisations\" data-id=\"115\">infrared oven for the medical sector<\/a>, made entirely of stainless steel and designed according to GMP standards.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Rapid tool changes: a SMED approach<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">In multi-spec production, changeover times directly impact productivity. We apply SMED principles to reduce them:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>quick-mounting, tool-free tools as soon as possible<\/li>\n\n\n\n<li>keying features and markings to prevent adjustment errors<\/li>\n\n\n\n<li>presetting of off-machine tooling<\/li>\n\n\n\n<li>motorized and servo-controlled adjustments, managed by recipes from the HMI<\/li>\n\n\n\n<li>operator-guided format change sequences<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Fewer manual adjustments also mean fewer interventions in clean areas and less risk of contamination. We have already designed lines managing more than 40 product references and 14 formats per recipe, in a cleanroom environment.<\/p>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-block-group-is-layout-constrained\">\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"977\" src=\"https:\/\/www.asm-indus.com\/wp-content\/uploads\/2026\/10\/20160608_155513-1024x977.jpg\" alt=\"Machine sp\u00e9ciale ASM en inox, \u00e0 capotage lisse et pieds r\u00e9glables, pour environnement propre\" class=\"wp-image-6037\" srcset=\"https:\/\/www.asm-indus.com\/wp-content\/uploads\/2026\/10\/20160608_155513-1024x977.jpg 1024w, https:\/\/www.asm-indus.com\/wp-content\/uploads\/2026\/10\/20160608_155513-300x286.jpg 300w, https:\/\/www.asm-indus.com\/wp-content\/uploads\/2026\/10\/20160608_155513-768x733.jpg 768w, https:\/\/www.asm-indus.com\/wp-content\/uploads\/2026\/10\/20160608_155513-1536x1466.jpg 1536w, https:\/\/www.asm-indus.com\/wp-content\/uploads\/2026\/10\/20160608_155513-13x12.jpg 13w, https:\/\/www.asm-indus.com\/wp-content\/uploads\/2026\/10\/20160608_155513.jpg 1920w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\">FAQ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Are your machines delivered with a qualification file?<\/strong><br>Each machine is delivered with its complete technical file: plans, diagrams, instruction manual, and CE marking. We prepare and execute the FAT and SAT protocols with you, and we support the IQ and OQ. The performance qualification (PQ), which is carried out with your product, remains the responsibility of your teams.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Can you perform the installation in a cleanroom setting?<\/strong><br>Yes, in accordance with your site&#039;s procedures: donning protective clothing, airlock access, and cleaning of equipment before entry. We prepare the intervention with your quality teams.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Do you work according to ISO 13485?<\/strong><br>We work for ISO 13485 certified medical device manufacturers and we adapt our documentation and deliverables to their quality system.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>What is the lead time for a cleanroom machine?<\/strong><br>It depends on the complexity of the machine and the level of qualification required. We will determine this with you as soon as we analyze the specifications.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ASM and HighTaiX, partners of healthcare manufacturers in the PACA region<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Since 1997, ASM has been designing custom-made special machines, from assisted workstations to fully automated lines. From our sites in the Alpes-Maritimes and Bouches-du-Rh\u00f4ne, we support healthcare stakeholders in the South region: medical device companies in Sophia Antipolis, biotechnology companies in Marseille and Aix-en-Provence, and more broadly, pharmaceutical manufacturers, both regionally and internationally.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Do you have an equipment project for your biotech production or cleanroom? Let&#039;s talk about it. <a href=\"https:\/\/www.asm-indus.com\/en\/contact\/\" data-type=\"page\" data-id=\"30\">Contact our teams<\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For an overview of our achievements in healthcare, please visit our page <a href=\"https:\/\/www.asm-indus.com\/en\/automatisation-et-robotique-de-haute-precision-pour-le-secteur-medical-et-pharmaceutique\/\" data-type=\"post\" data-id=\"329\">High-precision automation and robotics for the medical and pharmaceutical sectors<\/a>. This page details our expertise in cleanrooms, GMP and qualification.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>ASM has designed and installed more than 300 professional machines<\/em><em>Production. Here are some examples of projects that might interest you:<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.asm-indus.com\/en\/realisations\/four-a-infrarouge-pour-le-medical\/\" data-type=\"realisations\" data-id=\"115\">Infrared oven for the medical sector<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.asm-indus.com\/en\/automatisation-et-robotique-de-haute-precision-pour-le-secteur-medical-et-pharmaceutique\/\" data-type=\"post\" data-id=\"329\">Medical syringe assembly machine<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.asm-indus.com\/en\/realisations\/machine-d-assemblage-pour-le-medical-p96\/\" data-type=\"realisations\" data-id=\"1852\">Automated machine for medical valves<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.asm-indus.com\/en\/realisations\/ligne-production-automatisee-medical\/\" data-type=\"realisations\" data-id=\"426\">Automated production line for the medical field<\/a><\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>ASM et sa filiale HighTaiX con\u00e7oivent et fabriquent des \u00e9quipements de production sur mesure pour les industries des biotechnologies, de la sant\u00e9 et des dispositifs m\u00e9dicaux. Propret\u00e9, tra\u00e7abilit\u00e9, validation, hygi\u00e8ne : ces environnements imposent des exigences que les machines standard couvrent rarement. Notre m\u00e9tier est de concevoir des machines sp\u00e9ciales qui les int\u00e8grent d\u00e8s la [&hellip;]<\/p>\n","protected":false},"featured_media":6037,"template":"","types-de-machines":[],"secteurs":[],"class_list":["post-6033","realisations","type-realisations","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/www.asm-indus.com\/en\/wp-json\/wp\/v2\/realisations\/6033","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.asm-indus.com\/en\/wp-json\/wp\/v2\/realisations"}],"about":[{"href":"https:\/\/www.asm-indus.com\/en\/wp-json\/wp\/v2\/types\/realisations"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.asm-indus.com\/en\/wp-json\/wp\/v2\/media\/6037"}],"wp:attachment":[{"href":"https:\/\/www.asm-indus.com\/en\/wp-json\/wp\/v2\/media?parent=6033"}],"wp:term":[{"taxonomy":"types-de-machines","embeddable":true,"href":"https:\/\/www.asm-indus.com\/en\/wp-json\/wp\/v2\/types-de-machines?post=6033"},{"taxonomy":"secteurs","embeddable":true,"href":"https:\/\/www.asm-indus.com\/en\/wp-json\/wp\/v2\/secteurs?post=6033"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}