{"id":5322,"date":"2025-06-15T11:39:04","date_gmt":"2025-06-15T11:39:04","guid":{"rendered":"https:\/\/ingenic.es\/?p=5322"},"modified":"2026-08-01T08:06:50","modified_gmt":"2026-08-01T08:06:50","slug":"classificacio-iso-14644-en-sales-blanques","status":"publish","type":"post","link":"https:\/\/ingenic.es\/ca\/classificacio-iso-14644-en-sales-blanques\/","title":{"rendered":"Classificaci\u00f3 ISO 14644 en sales blanques: guia t\u00e8cnica de refer\u00e8ncia"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">Classificaci\u00f3 ISO 14644 en sales blanques: guia t\u00e8cnica de refer\u00e8ncia<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">La norma <strong>ISO 14644<\/strong> \u00e9s la refer\u00e8ncia internacional que defineix com es classifiquen les sales blanques en funci\u00f3 de la concentraci\u00f3 de part\u00edcules en l&#8217;aire. Aquesta normativa \u00e9s clau per assegurar que els processos cr\u00edtics, com la fabricaci\u00f3 farmac\u00e8utica, la recerca <strong><a href=\"https:\/\/ingenic.es\/ca\/biotecnologic\/\" data-type=\"page\" data-id=\"4953\">biotecnol\u00f2gica<\/a><\/strong> o la producci\u00f3 de microelectr\u00f2nica, es realitzin en entorns controlats i segurs.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Aqu\u00ed t&#8217;oferim una <strong>guia t\u00e8cnica<\/strong> de refer\u00e8ncia sobre la <strong>classificaci\u00f3 ISO 14644<\/strong> en <strong>sales blanques<\/strong>, explicant qu\u00e8 significa cada nivell i quins requisits implica per a la teva empresa.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Qu\u00e8 \u00e9s la norma ISO 14644?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">La <strong>ISO 14644<\/strong> \u00e9s un conjunt d&#8217;est\u00e0ndards internacionals que regulen la classificaci\u00f3 de <strong>sales blanques<\/strong>. El seu objectiu \u00e9s garantir que qualsevol instal\u00b7laci\u00f3 neta compleixi els nivells de puresa de l&#8217;aire necessaris segons el tipus d&#8217;activitat que es realitzi.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>La norma se centra en tres aspectes principals:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>El disseny i classificaci\u00f3 de sales blanques.<\/li>\n\n\n\n<li>Els procediments de monitoritzaci\u00f3 de part\u00edcules.<\/li>\n\n\n\n<li>La validaci\u00f3 i certificaci\u00f3 de les instal\u00b7lacions.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Classificaci\u00f3 ISO 14644: nivells principals<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">La norma estableix diferents classes de <strong>sales blanques<\/strong>, que van d&#8217;<strong>ISO 1<\/strong> a <strong>ISO 9<\/strong>, sent <strong>ISO 1<\/strong> la m\u00e9s estricta (major puresa) i <strong>ISO 9<\/strong> la menys exigent. A continuaci\u00f3, t&#8217;expliquem els nivells m\u00e9s comuns:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 1 \u2013 ISO 3:<\/strong> nivell de puresa extrema. \u00c9s el requisit per a la fabricaci\u00f3 de microxips i components electr\u00f2nics d&#8217;alta precisi\u00f3.<\/li>\n\n\n\n<li><strong>ISO 4 \u2013 ISO 5:<\/strong> alta exig\u00e8ncia. Comuna en la <strong><a href=\"https:\/\/ingenic.es\/ca\/industria-farmaceutica\/\" data-type=\"page\" data-id=\"5106\">ind\u00fastria farmac\u00e8utica<\/a><\/strong> i biotecnol\u00f2gica per a processos d&#8217;ompliment de medicaments.<\/li>\n\n\n\n<li><strong>ISO 6 \u2013 ISO 7:<\/strong> nivell mitj\u00e0-alt de control. Utilitzades en laboratoris de recerca, ind\u00fastria cosm\u00e8tica, hospitals o en la fabricaci\u00f3 de dispositius m\u00e8dics.<\/li>\n\n\n\n<li><strong>ISO 8 \u2013 ISO 9:<\/strong> nivell de control b\u00e0sic. Usades en la ind\u00fastria aliment\u00e0ria o en \u00e0rees d&#8217;empaquetament on la contaminaci\u00f3 \u00e9s un risc moderat.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Exemple pr\u00e0ctic: un quir\u00f2fan hospitalari sol classificar-se entre <strong>ISO 7<\/strong> i <strong>ISO 8<\/strong>, mentre que la producci\u00f3 de semiconductors requereix <strong>ISO 3<\/strong> o inferior.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Factors que determinen la classificaci\u00f3<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">La <strong>classificaci\u00f3 ISO 14644 en sales blanques<\/strong> no nom\u00e9s dep\u00e8n de la concentraci\u00f3 de part\u00edcules. Existeixen altres factors clau que hi influeixen:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Concentraci\u00f3 de part\u00edcules:<\/strong> es mesura amb equips especialitzats, registrant el nombre de part\u00edcules per metre c\u00fabic.<\/li>\n\n\n\n<li><strong>Sistemes de ventilaci\u00f3 i filtraci\u00f3:<\/strong> \u00e9s fonamental l&#8217;\u00fas de filtres HEPA o ULPA per garantir la puresa de l&#8217;aire.<\/li>\n\n\n\n<li><strong>Condicions ambientals controlades:<\/strong> la temperatura, la humitat i la pressi\u00f3 han de mantenir-se estables i dins dels marges de la normativa.<\/li>\n\n\n\n<li><strong>Disseny i materials de la sala:<\/strong> els acabats llisos i resistents, com l&#8217;acer inoxidable, s\u00f3n crucials per evitar l&#8217;acumulaci\u00f3 de contaminants.<\/li>\n\n\n\n<li><strong>Pr\u00e0ctiques d&#8217;acc\u00e9s i \u00fas:<\/strong> la classificaci\u00f3 de sales blanques tamb\u00e9 dep\u00e8n dels procediments que segueixi el personal per entrar i treballar a la sala.<\/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\">Per a m\u00e9s informaci\u00f3, pots consultar el nostre article dedicat a la Classificaci\u00f3 de sales blanques segons <strong>ISO 14644<\/strong>.<\/p>\n<\/blockquote>\n\n\n\n<h3 class=\"wp-block-heading\">ISO 14644 vs GMP i FDA<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Encara que la <strong>ISO 14644<\/strong> defineix les classes de puresa, la normativa <strong>GMP<\/strong> (Good Manufacturing Practices) regula els processos que s&#8217;han de complir en sectors com la <strong>ind\u00fastria farmac\u00e8utica<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Per la seva banda, la <strong>FDA<\/strong> als EUA exigeix que les sales compleixin tant amb <strong>GMP<\/strong> com amb la <strong>ISO 14644<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">En altres paraules: la <strong>ISO<\/strong> classifica t\u00e8cnicament l&#8217;ambient, mentre que <strong>GMP<\/strong> i <strong>FDA<\/strong> defineixen com s&#8217;ha de treballar dins d&#8217;aquestes <strong>sales blanques<\/strong> per garantir la qualitat final del producte. Es complementen per aconseguir la m\u00e0xima seguretat.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Com certificar una sala blanca segons ISO 14644?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">El proc\u00e9s de certificaci\u00f3 inclou:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Mesurament de part\u00edcules:<\/strong> s&#8217;utilitzen equips especialitzats per verificar la puresa de l&#8217;aire.<\/li>\n\n\n\n<li><strong>Validaci\u00f3 de sistemes:<\/strong> es comprova el correcte funcionament dels sistemes <strong><a href=\"https:\/\/ingenic.es\/ca\/hvac\/\" data-type=\"page\" data-id=\"5001\">HVAC<\/a><\/strong> i de filtraci\u00f3.<\/li>\n\n\n\n<li><strong>Documentaci\u00f3 de resultats:<\/strong> s&#8217;emet un informe de conformitat que registra els resultats dels mesuraments i la verificaci\u00f3.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">A <strong>Espanya<\/strong> i <strong>Europa<\/strong>, aquests assajos es realitzen per laboratoris acreditats i s\u00f3n requisit indispensable en sectors regulats.<\/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\">La <strong>classificaci\u00f3 ISO 14644 en sales blanques<\/strong> \u00e9s la base per garantir entorns controlats, segurs i adaptats a cada sector. Entendre quina classe necessita la teva empresa \u00e9s clau per complir amb normatives internacionals, optimitzar processos i assegurar la m\u00e0xima qualitat dels productes.<\/p>\n<\/blockquote>\n\n\n\n<h3 class=\"wp-block-heading\">Preguntes freq\u00fcents sobre la classificaci\u00f3 ISO 14644 en sales blanques<\/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\">Qu\u00e8 \u00e9s la classificaci\u00f3 ISO 14644 en sales blanques?<\/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\">\u00c9s l&#8217;est\u00e0ndard internacional que classifica les sales blanques segons la quantitat de part\u00edcules presents en l&#8217;aire.<\/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\">Quina difer\u00e8ncia hi ha entre ISO 1 i ISO 9?<\/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\">ISO 1 \u00e9s el nivell m\u00e9s net i exigent, mentre que ISO 9 permet una major concentraci\u00f3 de part\u00edcules i t\u00e9 requisits m\u00e9s flexibles.<\/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\">Quins factors influeixen en la classificaci\u00f3 ISO?<\/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\">Principalment la concentraci\u00f3 de part\u00edcules, el sistema de filtraci\u00f3, el control ambiental i el disseny de la sala.<\/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\">La ISO 14644 substitueix la normativa GMP?<\/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\">La certificaci\u00f3 es realitza a trav\u00e9s d&#8217;auditories i assajos que verifiquen el compliment de la <strong>ISO 14644<\/strong> i la normativa <strong>GMP<\/strong>. No, es complementen: la <strong>ISO defineix la neteja de l&#8217;aire<\/strong> i <strong>GMP regula els processos dins de la sala<\/strong>.<\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Classificaci\u00f3 ISO 14644 en sales blanques: guia t\u00e8cnica de refer\u00e8ncia La norma ISO 14644 \u00e9s la refer\u00e8ncia internacional que defineix com es classifiquen les sales blanques en funci\u00f3 de la concentraci\u00f3 de part\u00edcules en l&#8217;aire. Aquesta normativa \u00e9s clau per assegurar que els processos cr\u00edtics, com la fabricaci\u00f3 farmac\u00e8utica, la recerca biotecnol\u00f2gica o la producci\u00f3 de microelectr\u00f2nica, es realitzin en entorns controlats i segurs. Aqu\u00ed t&#8217;oferim una guia t\u00e8cnica de refer\u00e8ncia sobre la classificaci\u00f3 ISO 14644 en sales blanques, explicant qu\u00e8 significa cada nivell i quins requisits implica per a la teva empresa. Qu\u00e8 \u00e9s la norma ISO 14644? La ISO 14644 \u00e9s un conjunt d&#8217;est\u00e0ndards internacionals que regulen la classificaci\u00f3 de sales blanques. El seu objectiu \u00e9s garantir que qualsevol instal\u00b7laci\u00f3 neta compleixi els nivells de puresa de l&#8217;aire necessaris segons el tipus d&#8217;activitat que es realitzi. La norma se centra en tres aspectes principals: Classificaci\u00f3 ISO 14644: nivells principals La norma estableix diferents classes de sales blanques, que van d&#8217;ISO 1 a ISO 9, sent ISO 1 la m\u00e9s estricta (major puresa) i ISO 9 la menys exigent. A continuaci\u00f3, t&#8217;expliquem els nivells m\u00e9s comuns: Exemple pr\u00e0ctic: un quir\u00f2fan hospitalari sol classificar-se entre ISO 7 i ISO 8, mentre que la producci\u00f3 de semiconductors requereix ISO 3 o inferior. Factors que determinen la classificaci\u00f3 La classificaci\u00f3 ISO 14644 en sales blanques no nom\u00e9s dep\u00e8n de la concentraci\u00f3 de part\u00edcules. Existeixen altres factors clau que hi influeixen: Per a m\u00e9s informaci\u00f3, pots consultar el nostre article dedicat a la Classificaci\u00f3 de sales blanques segons ISO 14644. ISO 14644 vs GMP i FDA Encara que la ISO 14644 defineix les classes de puresa, la normativa GMP (Good Manufacturing Practices) regula els processos que s&#8217;han de complir en sectors com la ind\u00fastria farmac\u00e8utica. Per la seva banda, la FDA als EUA exigeix que les sales compleixin tant amb GMP com amb la ISO 14644. En altres paraules: la ISO classifica t\u00e8cnicament l&#8217;ambient, mentre que GMP i FDA defineixen com s&#8217;ha de treballar dins d&#8217;aquestes sales blanques per garantir la qualitat final del producte. Es complementen per aconseguir la m\u00e0xima seguretat. Com certificar una sala blanca segons ISO 14644? El proc\u00e9s de certificaci\u00f3 inclou: A Espanya i Europa, aquests assajos es realitzen per laboratoris acreditats i s\u00f3n requisit indispensable en sectors regulats. La classificaci\u00f3 ISO 14644 en sales blanques \u00e9s la base per garantir entorns controlats, segurs i adaptats a cada sector. Entendre quina classe necessita la teva empresa \u00e9s clau per complir amb normatives internacionals, optimitzar processos i assegurar la m\u00e0xima qualitat dels productes. Preguntes freq\u00fcents sobre la classificaci\u00f3 ISO 14644 en sales blanques<\/p>\n","protected":false},"author":2,"featured_media":5321,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[92,98,102,103],"tags":[],"class_list":["post-5322","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-iso","category-normatives","category-sala-blanca","category-sala-neta"],"acf":[],"_links":{"self":[{"href":"https:\/\/ingenic.es\/ca\/wp-json\/wp\/v2\/posts\/5322","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ingenic.es\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ingenic.es\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ingenic.es\/ca\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/ingenic.es\/ca\/wp-json\/wp\/v2\/comments?post=5322"}],"version-history":[{"count":1,"href":"https:\/\/ingenic.es\/ca\/wp-json\/wp\/v2\/posts\/5322\/revisions"}],"predecessor-version":[{"id":5329,"href":"https:\/\/ingenic.es\/ca\/wp-json\/wp\/v2\/posts\/5322\/revisions\/5329"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ingenic.es\/ca\/wp-json\/wp\/v2\/media\/5321"}],"wp:attachment":[{"href":"https:\/\/ingenic.es\/ca\/wp-json\/wp\/v2\/media?parent=5322"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ingenic.es\/ca\/wp-json\/wp\/v2\/categories?post=5322"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ingenic.es\/ca\/wp-json\/wp\/v2\/tags?post=5322"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}