{"id":6147,"date":"2025-08-15T13:24:10","date_gmt":"2025-08-15T13:24:10","guid":{"rendered":"https:\/\/ingenic.es\/?p=6147"},"modified":"2026-08-04T15:24:39","modified_gmt":"2026-08-04T15:24:39","slug":"cleanroom-design-and-construction","status":"publish","type":"post","link":"https:\/\/ingenic.es\/en\/cleanroom-design-and-construction\/","title":{"rendered":"Cleanroom design and construction"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Cleanroom design and construction<\/strong> is a process that requires technical precision, regulatory knowledge and hands-on execution experience. A <strong>white room<\/strong> is not just an enclosed space with filters: it&#8217;s a controlled environment where particle concentration, temperature, humidity and pressure are regulated to guarantee the quality and safety of manufactured products.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Compliance with international standards such as <strong>ISO 14644 and GMP (Good Manufacturing Practices)<\/strong> is essential for sectors such as pharmaceutical, cosmetic, biotechnological, hospital and food.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In this guide we show you the <strong>essential keys to designing and building white rooms<\/strong>, what systems are needed, and what mistakes to avoid to ensure your installation meets the most demanding standards.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Key aspects of cleanroom design<\/h3>\n\n\n\n<h4 class=\"wp-block-heading\">Preliminary study and defining requirements<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">The first step in designing a <strong>cleanroom<\/strong> is analyzing its intended use. Not all industries require the same level of purity: a <strong>pharmaceutical laboratory<\/strong> demands a higher standard than a food packaging plant.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Factors to consider at this stage:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Type of products or processes to be developed.<\/li>\n\n\n\n<li>Required <strong>ISO 14644<\/strong> classification (<em>from ISO 1 to ISO 9<\/em>).<\/li>\n\n\n\n<li>Applicable regulations: <strong>GMP<\/strong>, <strong>FDA<\/strong>, <strong>ISO<\/strong>, or country-specific regulations.<\/li>\n\n\n\n<li>Available space and possible future expansions.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">A good initial study avoids costly redesigns and ensures the room fulfills its purpose from the outset.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Layout and workflow design<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">The design must guarantee efficient, safe processes while preventing cross-contamination.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Some basic principles include:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Zone separation:<\/strong> establishing differentiated areas according to cleanliness level (changing rooms, preparation areas, production areas).<\/li>\n\n\n\n<li><strong>Staff and material flows:<\/strong> staff must enter through designated changing rooms, and materials through SAS or pass-through boxes.<\/li>\n\n\n\n<li><strong>Access control:<\/strong> only authorized personnel may enter, always following strict protocols.<\/li>\n\n\n\n<li><strong>Doors and airlocks:<\/strong> systems that prevent simultaneous opening to maintain differential pressure.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Selecting the right materials<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Construction materials are decisive for a <strong>cleanroom&#8217;s<\/strong> effectiveness. <strong><a href=\"https:\/\/ingenic.es\/en\/cleanroom-architecture\/\" data-type=\"page\" data-id=\"5748\">Cleanroom architecture<\/a><\/strong> must consider the use of modular solutions, smooth surfaces and finishes that facilitate cleaning and maintenance, ensuring regulatory compliance.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Panels:<\/strong> metal with a rock wool, PUR\/PIR or phenolic resin core, resistant and easy to clean.<\/li>\n\n\n\n<li><strong>Flooring:<\/strong> vinyl, epoxy or resin, continuous and joint-free to prevent particle buildup.<\/li>\n\n\n\n<li><strong>Furniture:<\/strong> stainless steel or phenolic resin, designed to withstand chemical products and facilitate cleaning.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Material selection must meet requirements for <strong>resistance, durability and ease of disinfection.<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Essential systems in white room construction<\/h3>\n\n\n\n<h4 class=\"wp-block-heading\">HVAC system and air filtration<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>The heart of any white room is its air conditioning and filtration system.<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>HEPA and ULPA filters:<\/strong> remove particles of 0.3 \u00b5m or smaller, guaranteeing clean air.<\/li>\n\n\n\n<li><strong>Laminar flow:<\/strong> air circulates in a single direction at a constant velocity, ideal for critical processes.<\/li>\n\n\n\n<li><strong>Turbulent flow:<\/strong> mixes the air, used in less-demanding areas.<\/li>\n\n\n\n<li><strong>Differential pressure control:<\/strong> ensures air flows from cleaner zones to less-clean zones.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Poor <strong><a href=\"https:\/\/ingenic.es\/en\/hvac\/\" data-type=\"page\" data-id=\"5763\">HVAC<\/a><\/strong> planning is one of the most costly mistakes in cleanroom construction.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\">Electricity and lighting<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Recessed, protected electrical installations to avoid contamination points.<\/li>\n\n\n\n<li>Low-consumption LED lighting, with diffusers that prevent dust buildup.<\/li>\n\n\n\n<li>Emergency systems and electrical redundancy for critical processes.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Control and instrumentation<\/h4>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Digitalization is key in modern rooms:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Periodic validation:<\/strong> ensures all systems maintain their effectiveness over time.<\/li>\n\n\n\n<li><strong>PLC and SCADA:<\/strong> allow real-time monitoring of variables such as particles, temperature and humidity.<\/li>\n\n\n\n<li><strong>Automatic alarms and records:<\/strong> guarantee traceability and meet GMP audit requirements.<\/li>\n<\/ul>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">For more information, you can check our article on cleanroom classification according to <strong>ISO 14644<\/strong>.<\/p>\n<\/blockquote>\n\n\n\n<h3 class=\"wp-block-heading\">Applicable regulations for design and construction<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 14644:<\/strong> defines cleanroom classification by particle concentration.<\/li>\n\n\n\n<li><strong>GMP:<\/strong> regulates manufacturing processes and requires strict hygiene and control conditions.<\/li>\n\n\n\n<li><strong>FDA:<\/strong> US regulation that applies to companies with international operations.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Integrating these regulations from the design phase ensures the room is ready for certifications and audits without costly corrections.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Common mistakes in cleanroom design and construction<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Not defining the ISO level from the start:<\/strong> can lead to over-sizing or regulatory non-compliance.<\/li>\n\n\n\n<li><strong>Choosing unsuitable materials:<\/strong> some porous materials hinder cleaning and accumulate contaminants.<\/li>\n\n\n\n<li><strong>Poorly designed flows:<\/strong> staff and material access without adequate separation.<\/li>\n\n\n\n<li><strong>Overspending on unnecessary systems:<\/strong> poorly planned design increases costs without adding value.<\/li>\n\n\n\n<li><strong>Lack of documentation:<\/strong> without clear records, <strong>GMP<\/strong> or <strong>ISO<\/strong> audits will not pass.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Costs and factors influencing the budget<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>The cost of a cleanroom depends on:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Required ISO classification level.<\/li>\n\n\n\n<li>Size and complexity of the design.<\/li>\n\n\n\n<li>Selected materials (panels, flooring, furniture).<\/li>\n\n\n\n<li>HVAC and filtration systems.<\/li>\n\n\n\n<li>Instrumentation and digitalization.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Although the initial investment is significant, a well-designed room translates into <strong>greater efficiency, fewer risks and guaranteed regulatory compliance.<\/strong><\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\"><strong>White room design and construction<\/strong> is a critical process that requires technical expertise, regulatory knowledge and appropriate materials. A properly planned installation ensures compliance with <strong>ISO 14644<\/strong> and <strong>GMP<\/strong>, optimizes processes, and protects both products and people.<\/p>\n<\/blockquote>\n\n\n\n<h3 class=\"wp-block-heading\">Frequently asked questions about ISO 14644 classification in white rooms<\/h3>\n\n\n\n<div data-wp-context=\"{ &quot;autoclose&quot;: false, &quot;accordionItems&quot;: [] }\" data-wp-interactive=\"core\/accordion\" role=\"group\" class=\"wp-block-accordion is-layout-flow wp-block-accordion-is-layout-flow\">\n<div data-wp-class--is-open=\"state.isOpen\" data-wp-context=\"{ &quot;id&quot;: &quot;accordion-item-1&quot;, &quot;openByDefault&quot;: false }\" data-wp-init=\"callbacks.initAccordionItems\" data-wp-on-window--hashchange=\"callbacks.hashChange\" class=\"wp-block-accordion-item is-layout-flow wp-block-accordion-item-is-layout-flow\">\n<h3 class=\"wp-block-accordion-heading\"><button aria-expanded=\"false\" aria-controls=\"accordion-item-1-panel\" data-wp-bind--aria-expanded=\"state.isOpen\" data-wp-on--click=\"actions.toggle\" data-wp-on--keydown=\"actions.handleKeyDown\" id=\"accordion-item-1\" type=\"button\" class=\"wp-block-accordion-heading__toggle\"><span class=\"wp-block-accordion-heading__toggle-title\">What is needed to design a white room correctly?<\/span><span class=\"wp-block-accordion-heading__toggle-icon\" aria-hidden=\"true\">+<\/span><\/button><\/h3>\n\n\n\n<div inert aria-labelledby=\"accordion-item-1\" data-wp-bind--inert=\"!state.isOpen\" id=\"accordion-item-1-panel\" role=\"region\" class=\"wp-block-accordion-panel is-layout-flow wp-block-accordion-panel-is-layout-flow\">\n<p class=\"wp-block-paragraph\">The ISO level, process type and applicable regulations must be defined, and environmental control systems designed from the outset.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div data-wp-class--is-open=\"state.isOpen\" data-wp-context=\"{ &quot;id&quot;: &quot;accordion-item-2&quot;, &quot;openByDefault&quot;: false }\" data-wp-init=\"callbacks.initAccordionItems\" data-wp-on-window--hashchange=\"callbacks.hashChange\" class=\"wp-block-accordion-item is-layout-flow wp-block-accordion-item-is-layout-flow\">\n<h3 class=\"wp-block-accordion-heading\"><button aria-expanded=\"false\" aria-controls=\"accordion-item-2-panel\" data-wp-bind--aria-expanded=\"state.isOpen\" data-wp-on--click=\"actions.toggle\" data-wp-on--keydown=\"actions.handleKeyDown\" id=\"accordion-item-2\" type=\"button\" class=\"wp-block-accordion-heading__toggle\"><span class=\"wp-block-accordion-heading__toggle-title\">What regulations must a white room comply with?<\/span><span class=\"wp-block-accordion-heading__toggle-icon\" aria-hidden=\"true\">+<\/span><\/button><\/h3>\n\n\n\n<div inert aria-labelledby=\"accordion-item-2\" data-wp-bind--inert=\"!state.isOpen\" id=\"accordion-item-2-panel\" role=\"region\" class=\"wp-block-accordion-panel is-layout-flow wp-block-accordion-panel-is-layout-flow\">\n<p class=\"wp-block-paragraph\">Mainly ISO 14644, GMP and, in some cases, FDA regulations.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div data-wp-class--is-open=\"state.isOpen\" data-wp-context=\"{ &quot;id&quot;: &quot;accordion-item-3&quot;, &quot;openByDefault&quot;: false }\" data-wp-init=\"callbacks.initAccordionItems\" data-wp-on-window--hashchange=\"callbacks.hashChange\" class=\"wp-block-accordion-item is-layout-flow wp-block-accordion-item-is-layout-flow\">\n<h3 class=\"wp-block-accordion-heading\"><button aria-expanded=\"false\" aria-controls=\"accordion-item-3-panel\" data-wp-bind--aria-expanded=\"state.isOpen\" data-wp-on--click=\"actions.toggle\" data-wp-on--keydown=\"actions.handleKeyDown\" id=\"accordion-item-3\" type=\"button\" class=\"wp-block-accordion-heading__toggle\"><span class=\"wp-block-accordion-heading__toggle-title\">What is the most important element in a white room?<\/span><span class=\"wp-block-accordion-heading__toggle-icon\" aria-hidden=\"true\">+<\/span><\/button><\/h3>\n\n\n\n<div inert aria-labelledby=\"accordion-item-3\" data-wp-bind--inert=\"!state.isOpen\" id=\"accordion-item-3-panel\" role=\"region\" class=\"wp-block-accordion-panel is-layout-flow wp-block-accordion-panel-is-layout-flow\">\n<p class=\"wp-block-paragraph\">The HVAC system, since it controls filtration, airflow, temperature and pressure.<\/p>\n<\/div>\n<\/div>\n\n\n\n<div data-wp-class--is-open=\"state.isOpen\" data-wp-context=\"{ &quot;id&quot;: &quot;accordion-item-4&quot;, &quot;openByDefault&quot;: false }\" data-wp-init=\"callbacks.initAccordionItems\" data-wp-on-window--hashchange=\"callbacks.hashChange\" class=\"wp-block-accordion-item is-layout-flow wp-block-accordion-item-is-layout-flow\">\n<h3 class=\"wp-block-accordion-heading\"><button aria-expanded=\"false\" aria-controls=\"accordion-item-4-panel\" data-wp-bind--aria-expanded=\"state.isOpen\" data-wp-on--click=\"actions.toggle\" data-wp-on--keydown=\"actions.handleKeyDown\" id=\"accordion-item-4\" type=\"button\" class=\"wp-block-accordion-heading__toggle\"><span class=\"wp-block-accordion-heading__toggle-title\">What mistakes should be avoided when building white rooms?<\/span><span class=\"wp-block-accordion-heading__toggle-icon\" aria-hidden=\"true\">+<\/span><\/button><\/h3>\n\n\n\n<div inert aria-labelledby=\"accordion-item-4\" data-wp-bind--inert=\"!state.isOpen\" id=\"accordion-item-4-panel\" role=\"region\" class=\"wp-block-accordion-panel is-layout-flow wp-block-accordion-panel-is-layout-flow\">\n<p class=\"wp-block-paragraph\">Not defining the ISO level, choosing unsuitable materials, or poorly designing staff and material flows.ateriales inadecuados o dise\u00f1ar mal los flujos de personal y materiales.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\">At <strong>ISL Salas Limpias<\/strong>, we support you at every stage, from initial design through execution and certification, ensuring your white room meets the highest international standards.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Cleanroom design and construction is a process that requires technical precision, regulatory knowledge and hands-on execution experience.<\/p>\n","protected":false},"author":2,"featured_media":6146,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[104,105,99],"tags":[],"class_list":["post-6147","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cleanroom","category-cleanroom-2","category-regulations"],"acf":[],"_links":{"self":[{"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/posts\/6147","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/comments?post=6147"}],"version-history":[{"count":1,"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/posts\/6147\/revisions"}],"predecessor-version":[{"id":6148,"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/posts\/6147\/revisions\/6148"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/media\/6146"}],"wp:attachment":[{"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/media?parent=6147"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/categories?post=6147"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ingenic.es\/en\/wp-json\/wp\/v2\/tags?post=6147"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}