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_module_preset=\u00bbdefault\u00bb width=\u00bb100px\u00bb global_module=\u00bb4392967&#8243; saved_tabs=\u00bball\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{%22gcid-28f18998-2392-4899-ac10-6ddd6c851b9f%22:%91%22color%22%93}\u00bb][\/et_pb_divider][et_pb_text _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bb1f09816e-184e-4ce5-a4cf-b39c52c423ca\u00bb text_line_height=\u00bb1.4em\u00bb custom_margin=\u00bb|||60px|false|false\u00bb custom_margin_tablet=\u00bb|||0px|false|false\u00bb custom_margin_phone=\u00bb|||0px|false|false\u00bb custom_margin_last_edited=\u00bbon|tablet\u00bb hover_enabled=\u00bb0&#8243; text_font_size_tablet=\u00bb15px\u00bb text_font_size_phone=\u00bb14px\u00bb text_font_size_last_edited=\u00bbon|phone\u00bb header_font_size_tablet=\u00bb55px\u00bb header_font_size_last_edited=\u00bboff|desktop\u00bb global_colors_info=\u00bb{}\u00bb sticky_enabled=\u00bb0&#8243;]<\/p>\n<p>A <strong>cleanroom<\/strong> is a chamber within which the concentration of airborne particles is controlled, and <br \/>which is constructed and used to minimize the introduction, generation and retention of particles <br \/>within it.<\/p>\n<p>The main reference for controlled contamination environments and their plants is the <strong>international standard EN ISO 14644<\/strong>, which consists of 10 parts.<\/p>\n<p>Classes can be measured in 3 typical occupational conditions:<\/p>\n<ol>\n<li>The<strong> first occupational condition<\/strong> is that of a newly built cleanroom, as built, functioning but without process equipment and operators inside it (As built).<\/li>\n<li>The<strong> second condition<\/strong> is that of rest (At rest), indicating a cleanroom equipped for the production process with all the equipment in operation but in the absence of production and personnel.<\/li>\n<li>A cleanroom that is in operating condition, is with<strong> the production in progress and the present <\/strong><strong>personnel<\/strong> is indicated with the operating occupational condition or status (Operational).<\/li>\n<\/ol>\n<p>[\/et_pb_text][et_pb_button button_url=\u00bb@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjUwIn19@\u00bb button_text=\u00bbContact Us\u00bb _builder_version=\u00bb4.27.4&#8243; 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_module_preset=\u00bbb327cbe4-b1d5-4b66-ad37-40c8f2f061ba\u00bb header_2_font=\u00bb||||||||\u00bb header_2_font_size_tablet=\u00bb32px\u00bb header_2_font_size_phone=\u00bb20px\u00bb header_2_font_size_last_edited=\u00bboff|desktop\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2><strong>Standards and classes of contamination<\/strong><\/h2>\n<p>[\/et_pb_text][et_pb_divider color=\u00bbgcid-28f18998-2392-4899-ac10-6ddd6c851b9f\u00bb divider_weight=\u00bb4px\u00bb _builder_version=\u00bb4.20.0&#8243; _module_preset=\u00bbdefault\u00bb width=\u00bb100px\u00bb global_module=\u00bb4392967&#8243; saved_tabs=\u00bball\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{%22gcid-28f18998-2392-4899-ac10-6ddd6c851b9f%22:%91%22color%22%93}\u00bb][\/et_pb_divider][et_pb_text _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bb1f09816e-184e-4ce5-a4cf-b39c52c423ca\u00bb text_line_height=\u00bb1.4em\u00bb custom_margin=\u00bb|||60px|false|false\u00bb custom_margin_tablet=\u00bb|||0px|false|false\u00bb custom_margin_phone=\u00bb|||0px|false|false\u00bb custom_margin_last_edited=\u00bbon|tablet\u00bb text_font_size_tablet=\u00bb15px\u00bb text_font_size_phone=\u00bb14px\u00bb text_font_size_last_edited=\u00bbon|phone\u00bb header_font_size_tablet=\u00bb55px\u00bb header_font_size_last_edited=\u00bboff|desktop\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p><strong>EN ISO 14644-1:2015<\/strong> defines the class by means of an \u00abN\u00bb number, which can be the maximum of 9. However, <strong>class ISO 9<\/strong> can only be used under operating conditions. Depending on the particle diameter, the maximum allowable particle concentrations (upper limit) are given in the following table.<br \/>It shall indicate the contamination classes with the corresponding particle concentration values.<br \/>Ultimately, the designation of a particle contamination class for EN ISO 14644-1:2015 shall include:<br \/><strong>&#8211; the number of classification according to ISO N class;<br \/>&#8211; the employment status for which the classification is to be carried out,<br \/>&#8211; the diameter of the particle or particles concerned and their concentrations as calculated by the formula given above,<br \/>&#8211; if the class is checked for two diameters, the diameter of the largest particle shall be at least 1,5 times larger than the smallest.<\/strong><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_2&#8243; _builder_version=\u00bb4.18.0&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_image src=\u00bbhttps:\/\/www.commissioningimpianti.it\/wp-content\/uploads\/2023\/05\/modifiche-commissioning.png\u00bb alt=\u00bbclassificazione-locali-farmaceutici\u00bb title_text=\u00bbmodifiche commissioning\u00bb _builder_version=\u00bb4.21.0&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\u00bb1&#8243; module_id=\u00bbour-service\u00bb _builder_version=\u00bb4.27.4&#8243; background_color=\u00bb#e8f6ff\u00bb width=\u00bb95%\u00bb module_alignment=\u00bbcenter\u00bb custom_margin=\u00bb||4vh||false|false\u00bb custom_padding=\u00bb8vh||8vh||true|false\u00bb hover_enabled=\u00bb0&#8243; global_colors_info=\u00bb{}\u00bb disabled_on=\u00bbon|on|on\u00bb disabled=\u00bbon\u00bb sticky_enabled=\u00bb0&#8243;][et_pb_row column_structure=\u00bb1_2,1_2&#8243; _builder_version=\u00bb4.19.4&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb][et_pb_column 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global_colors_info=\u00bb{%22gcid-aef5f7d8-d4d0-4cf3-aa5c-26436510fceb%22:%91%22header_4_text_color%22%93,%22gcid-28f18998-2392-4899-ac10-6ddd6c851b9f%22:%91%22text_text_color%22%93}\u00bb]@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IiIsImFmdGVyIjoiIn19@[\/et_pb_text][et_pb_text _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bbb327cbe4-b1d5-4b66-ad37-40c8f2f061ba\u00bb header_2_font=\u00bb||||||||\u00bb header_2_font_size_tablet=\u00bb32px\u00bb header_2_font_size_phone=\u00bb20px\u00bb header_2_font_size_last_edited=\u00bboff|desktop\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<h2>How to test<\/h2>\n<p>[\/et_pb_text][et_pb_divider color=\u00bbgcid-28f18998-2392-4899-ac10-6ddd6c851b9f\u00bb divider_weight=\u00bb4px\u00bb _builder_version=\u00bb4.20.0&#8243; _module_preset=\u00bbdefault\u00bb width=\u00bb100px\u00bb global_module=\u00bb4392967&#8243; saved_tabs=\u00bball\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{%22gcid-28f18998-2392-4899-ac10-6ddd6c851b9f%22:%91%22color%22%93}\u00bb][\/et_pb_divider][et_pb_text _builder_version=\u00bb4.27.4&#8243; _module_preset=\u00bb1f09816e-184e-4ce5-a4cf-b39c52c423ca\u00bb text_line_height=\u00bb1.4em\u00bb custom_margin=\u00bb|||60px|false|false\u00bb custom_margin_tablet=\u00bb|||0px|false|false\u00bb custom_margin_phone=\u00bb|||0px|false|false\u00bb custom_margin_last_edited=\u00bbon|tablet\u00bb text_font_size_tablet=\u00bb15px\u00bb text_font_size_phone=\u00bb14px\u00bb text_font_size_last_edited=\u00bbon|phone\u00bb header_font_size_tablet=\u00bb55px\u00bb header_font_size_last_edited=\u00bboff|desktop\u00bb global_colors_info=\u00bb{}\u00bb]<\/p>\n<p>The minimum number of points at which concentration measurements are to be made shall be calculated as a <strong>function of the cleanroom surface<\/strong>.<\/p>\n<p>For statistical consistency with the adopted hypergeometric distribution model, <strong>the cleanroom shall be divided into equal sectors and the sampling point shall be representative of each sector<\/strong>.<\/p>\n<p>During the <strong>sampling phase<\/strong>, the optical particle counter shall be used according to the factory instructions and the probe shall always be placed in the direction of the air flow, if known, otherwise always in the vertical upward position.<\/p>\n<p><strong>Contact us to learn more and request our intervention: we will offer you the assistance you need!<\/strong><\/p>\n<p>[\/et_pb_text][et_pb_button button_url=\u00bb@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjUwIn19@\u00bb button_text=\u00bbContact Us\u00bb _builder_version=\u00bb4.27.4&#8243; _dynamic_attributes=\u00bbbutton_url\u00bb _module_preset=\u00bb31b4f027-aaa0-4f2f-ae02-959764e19e4f\u00bb custom_button=\u00bbon\u00bb button_text_size=\u00bb14px\u00bb button_text_color=\u00bb#FFFFFF\u00bb 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href=\"\">\u00bbAeraulic<\/a><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div><\/p>\n","protected":false},"author":1,"featured_media":0,"parent":4395982,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"dipi_cpt_category":[],"class_list":["post-4395974","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Particulate contamination - Commissioning Impianti Srl<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.commissioningimpianti.it\/es\/particulate-contamination\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" 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