{"id":114375,"date":"2024-04-12T09:36:12","date_gmt":"2024-04-12T07:36:12","guid":{"rendered":"https:\/\/webserver.gfps.de\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/"},"modified":"2024-06-15T10:01:32","modified_gmt":"2024-06-15T08:01:32","slug":"cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications","status":"publish","type":"page","link":"https:\/\/www.gfps.de\/en\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/","title":{"rendered":"Cleanroom qualification and confirmation of existing cleanroom qualifications"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;60&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; back_color=&#8221;color-nhtu&#8221; back_image=&#8221;112122&#8243; back_position=&#8221;center center&#8221; overlay_color=&#8221;color-983180&#8243; overlay_alpha=&#8221;51&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; enable_bottom_divider=&#8221;default&#8221; bottom_divider=&#8221;gradient&#8221; shape_bottom_h_use_pixel=&#8221;true&#8221; shape_bottom_height_percent=&#8221;100&#8243; shape_bottom_color=&#8221;accent&#8221; shape_bottom_opacity=&#8221;90&#8243; shape_bottom_index=&#8221;0&#8243; row_height_pixel=&#8221;280&#8243; row_name=&#8221;Intro&#8221; uncode_shortcode_id=&#8221;180676&#8243; back_color_type=&#8221;uncode-palette&#8221; shape_bottom_color_type=&#8221;uncode-palette&#8221; overlay_color_type=&#8221;uncode-palette&#8221;][vc_column column_width_percent=&#8221;100&#8243; position_horizontal=&#8221;left&#8221; position_vertical=&#8221;bottom&#8221; gutter_size=&#8221;1&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; style=&#8221;dark&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; align_medium=&#8221;align_left_tablet&#8221; medium_width=&#8221;0&#8243; align_mobile=&#8221;align_left_mobile&#8221; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_speed=&#8221;1000&#8243; width=&#8221;1\/1&#8243; uncode_shortcode_id=&#8221;100446&#8243;][vc_custom_heading heading_semantic=&#8221;h3&#8243; text_font=&#8221;font-453567&#8243; text_size=&#8221;h4&#8243; text_weight=&#8221;300&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-210350&#8243; sub_lead=&#8221;yes&#8221; sub_reduced=&#8221;yes&#8221; uncode_shortcode_id=&#8221;162828&#8243;]Clean room[\/vc_custom_heading][vc_custom_heading heading_semantic=&#8221;h1&#8243; text_size=&#8221;fontsize-155944&#8243; text_weight=&#8221;800&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-111509&#8243; sub_lead=&#8221;yes&#8221; sub_reduced=&#8221;yes&#8221; uncode_shortcode_id=&#8221;130033&#8243;]Cleanroom qualification and confirmation of existing cleanroom qualifications[\/vc_custom_heading][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;0&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; back_color=&#8221;color-lxmt&#8221; overlay_alpha=&#8221;0&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; style=&#8221;inherited&#8221; uncode_shortcode_id=&#8221;106173&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;2&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; style=&#8221;light&#8221; back_color=&#8221;color-lxmt&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; align_medium=&#8221;align_left_tablet&#8221; medium_width=&#8221;0&#8243; align_mobile=&#8221;align_left_mobile&#8221; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_delay=&#8221;200&#8243; width=&#8221;3\/4&#8243; uncode_shortcode_id=&#8221;116340&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_column_text uncode_shortcode_id=&#8221;137609&#8243;]The cleanroom is a controlled environment in which the concentration of particles, microorganisms and other impurities is kept at an extremely low level. Such environments are essential in a wide range of industries, including pharmaceuticals, microelectronics, the food industry and medical technology. In these areas, even the slightest contamination can impair product quality, safety and performance.[\/vc_column_text][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; overlay_alpha=&#8221;0&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_visibility=&#8221;yes&#8221; medium_width=&#8221;0&#8243; mobile_visibility=&#8221;yes&#8221; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_delay=&#8221;400&#8243; zoom_width=&#8221;0&#8243; zoom_height=&#8221;0&#8243; width=&#8221;1\/4&#8243; uncode_shortcode_id=&#8221;184491&#8243;][\/vc_column][\/vc_row][vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;55&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; back_color=&#8221;color-nhtu&#8221; overlay_alpha=&#8221;0&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; style=&#8221;inherited&#8221;][vc_column column_width_percent=&#8221;100&#8243; position_vertical=&#8221;middle&#8221; align_horizontal=&#8221;align_center&#8221; gutter_size=&#8221;3&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;4&#8243; back_color=&#8221;color-rgdb&#8221; back_image=&#8221;112122&#8243; back_position=&#8221;center center&#8221; overlay_alpha=&#8221;0&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; medium_visibility=&#8221;yes&#8221; medium_width=&#8221;0&#8243; mobile_visibility=&#8221;yes&#8221; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_delay=&#8221;400&#8243; zoom_width=&#8221;0&#8243; zoom_height=&#8221;0&#8243; width=&#8221;1\/4&#8243; uncode_shortcode_id=&#8221;104159&#8243; back_color_type=&#8221;uncode-palette&#8221;][\/vc_column][vc_column column_width_percent=&#8221;100&#8243; gutter_size=&#8221;2&#8243; override_padding=&#8221;yes&#8221; column_padding=&#8221;3&#8243; style=&#8221;light&#8221; back_color=&#8221;color-xsdn&#8221; overlay_alpha=&#8221;50&#8243; shift_x=&#8221;0&#8243; shift_y=&#8221;0&#8243; shift_y_down=&#8221;0&#8243; z_index=&#8221;0&#8243; align_medium=&#8221;align_left_tablet&#8221; medium_width=&#8221;0&#8243; align_mobile=&#8221;align_left_mobile&#8221; mobile_width=&#8221;0&#8243; css_animation=&#8221;bottom-t-top&#8221; animation_delay=&#8221;200&#8243; width=&#8221;3\/4&#8243; uncode_shortcode_id=&#8221;382031&#8243; back_color_type=&#8221;uncode-palette&#8221;][vc_custom_heading text_font=&#8221;font-136269&#8243; text_weight=&#8221;800&#8243; text_transform=&#8221;uppercase&#8221; text_space=&#8221;fontspace-111509&#8243; text_uppercase=&#8221;&#8221; text_align=&#8221;text-left&#8221; uncode_shortcode_id=&#8221;158228&#8243;]Cleanroom qualification and requalification[\/vc_custom_heading][vc_column_text uncode_shortcode_id=&#8221;953928&#8243;]<strong>Cleanroom qualification<\/strong> is the process of ensuring that a cleanroom meets the specified standards. It includes an assessment and monitoring of environmental conditions, including air quality, temperature, humidity and pressure differences.<br \/>\nA cleanroom qualification comprises three levels: (IQ, OQ, PQ) (as built, at rest, in operation).<\/p>\n<p>For qualification purposes, we differentiate between physical and microbiological tests\/measurements\/sampling:<\/p>\n<ul>\n<li>Particle measurement of the room or supply air<\/li>\n<li>Air flow and air exchange rate<\/li>\n<li>Uniformity of the air flow<\/li>\n<li>Flow visualization<\/li>\n<li>Differential pressure \/ displacement flow<\/li>\n<li>Temperature and relative humidity<\/li>\n<li>Sound pressure level<\/li>\n<li>Filter leak test<\/li>\n<li>Recovery time<\/li>\n<li>Microbiological air analysis<\/li>\n<li>Microbiological surface examination<\/li>\n<li>Microbiological workplace testing<\/li>\n<li>Compressed gas quality<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_column_text uncode_shortcode_id=&#8221;192499&#8243;]<strong> Cleanroom requalification<\/strong> requires regular repetition and confirms that your production environment continues to maintain the required cleanliness standards. During requalification, the tests carried out when the cleanroom was commissioned serve as a database.<\/p>\n<p>In accordance with the guidelines, we recommend that you schedule a regular review (e.g. 1x \/ 2x per year) to ensure that your qualifications are always up to date.<\/p>\n<p>Changes to the production environment, e.g. due to structural changes or changes to the air conditioning system, require a new cleanroom qualification.[\/vc_column_text][vc_empty_space empty_h=&#8221;1&#8243;][vc_separator sep_color=&#8221;accent&#8221; uncode_shortcode_id=&#8221;843798&#8243; sep_color_type=&#8221;uncode-palette&#8221;][vc_empty_space empty_h=&#8221;1&#8243;][vc_column_text uncode_shortcode_id=&#8221;191889&#8243;]<strong>According to standards:<br \/>\n<\/strong><\/p>\n<ul>\n<li>DIN EN ISO 14644<\/li>\n<li>EU GMP Guideline Annex 1<\/li>\n<li>VDI 2083<\/li>\n<li>DIN EN 17141<\/li>\n<li>DIN 1946<\/li>\n<li>ZLG document<\/li>\n<\/ul>\n<p>[\/vc_column_text][vc_empty_space empty_h=&#8221;1&#8243;][vc_separator sep_color=&#8221;color-983180&#8243; uncode_shortcode_id=&#8221;107261&#8243; sep_color_type=&#8221;uncode-palette&#8221;][vc_empty_space empty_h=&#8221;1&#8243;][vc_column_text uncode_shortcode_id=&#8221;681420&#8243;]We are at your disposal with our expertise. Please feel free to contact us: <strong><a href=\"mailto:aussendienst@gfps.de\">aussendienst@gfps.de<\/a><\/strong>[\/vc_column_text][vc_empty_space empty_h=&#8221;1&#8243;][vc_separator sep_color=&#8221;color-983180&#8243; uncode_shortcode_id=&#8221;107261&#8243; sep_color_type=&#8221;uncode-palette&#8221;][vc_empty_space empty_h=&#8221;1&#8243;][vc_button button_color=&#8221;accent&#8221; border_width=&#8221;0&#8243; button_color_type=&#8221;uncode-palette&#8221; uncode_shortcode_id=&#8221;209897&#8243; link=&#8221;url:https%3A%2F%2Fwebserver.gfps.de%2Fen%2Fcleanroom-qualification-commissioning-confirmation-of-existing-cleanroom-qualifications-requalification%2F|title:Cleanroom%20qualification%20%28commissioning%29%20%2F%20confirmation%20of%20existing%20cleanroom%20qualifications%20%28requalification%29|&#8221;]To the &#8220;Cleanroom qualification&#8221; overview[\/vc_button][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row unlock_row_content=&#8221;yes&#8221; row_height_percent=&#8221;60&#8243; override_padding=&#8221;yes&#8221; h_padding=&#8221;0&#8243; top_padding=&#8221;0&#8243; bottom_padding=&#8221;0&#8243; back_color=&#8221;color-nhtu&#8221; back_image=&#8221;112122&#8243; back_position=&#8221;center center&#8221; overlay_color=&#8221;color-983180&#8243; overlay_alpha=&#8221;51&#8243; equal_height=&#8221;yes&#8221; gutter_size=&#8221;0&#8243; column_width_percent=&#8221;100&#8243; shift_y=&#8221;0&#8243; z_index=&#8221;0&#8243; enable_bottom_divider=&#8221;default&#8221; bottom_divider=&#8221;gradient&#8221; [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-114375","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Cleanroom qualification - GfPS<\/title>\n<meta name=\"description\" content=\"The cleanroom is a controlled environment in which the concentration of particles, microorganisms and other...\" \/>\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.gfps.de\/en\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cleanroom qualification - GfPS\" \/>\n<meta property=\"og:description\" content=\"The cleanroom is a controlled environment in which the concentration of particles, microorganisms and other...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.gfps.de\/en\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/\" \/>\n<meta property=\"og:site_name\" content=\"GfPS\" \/>\n<meta property=\"article:modified_time\" content=\"2024-06-15T08:01:32+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.gfps.de\/en\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/\",\"url\":\"https:\/\/www.gfps.de\/en\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/\",\"name\":\"Cleanroom qualification - GfPS\",\"isPartOf\":{\"@id\":\"https:\/\/www.gfps.de\/en\/#website\"},\"datePublished\":\"2024-04-12T07:36:12+00:00\",\"dateModified\":\"2024-06-15T08:01:32+00:00\",\"description\":\"The cleanroom is a controlled environment in which the concentration of particles, microorganisms and other...\",\"breadcrumb\":{\"@id\":\"https:\/\/www.gfps.de\/en\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.gfps.de\/en\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.gfps.de\/en\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\/\/www.gfps.de\/en\/home\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Cleanroom qualification and confirmation of existing cleanroom qualifications\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.gfps.de\/en\/#website\",\"url\":\"https:\/\/www.gfps.de\/en\/\",\"name\":\"GfPS\",\"description\":\"Gepr\u00fcfte Qualit\u00e4t f\u00fcr Ihre Medizinprodukte\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.gfps.de\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Cleanroom qualification - GfPS","description":"The cleanroom is a controlled environment in which the concentration of particles, microorganisms and other...","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.gfps.de\/en\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/","og_locale":"en_US","og_type":"article","og_title":"Cleanroom qualification - GfPS","og_description":"The cleanroom is a controlled environment in which the concentration of particles, microorganisms and other...","og_url":"https:\/\/www.gfps.de\/en\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/","og_site_name":"GfPS","article_modified_time":"2024-06-15T08:01:32+00:00","twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.gfps.de\/en\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/","url":"https:\/\/www.gfps.de\/en\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/","name":"Cleanroom qualification - GfPS","isPartOf":{"@id":"https:\/\/www.gfps.de\/en\/#website"},"datePublished":"2024-04-12T07:36:12+00:00","dateModified":"2024-06-15T08:01:32+00:00","description":"The cleanroom is a controlled environment in which the concentration of particles, microorganisms and other...","breadcrumb":{"@id":"https:\/\/www.gfps.de\/en\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.gfps.de\/en\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.gfps.de\/en\/cleanroom-qualification-and-confirmation-of-existing-cleanroom-qualifications\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/www.gfps.de\/en\/home\/"},{"@type":"ListItem","position":2,"name":"Cleanroom qualification and confirmation of existing cleanroom qualifications"}]},{"@type":"WebSite","@id":"https:\/\/www.gfps.de\/en\/#website","url":"https:\/\/www.gfps.de\/en\/","name":"GfPS","description":"Gepr\u00fcfte Qualit\u00e4t f\u00fcr Ihre Medizinprodukte","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.gfps.de\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"}]}},"_links":{"self":[{"href":"https:\/\/www.gfps.de\/en\/wp-json\/wp\/v2\/pages\/114375","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.gfps.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.gfps.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.gfps.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.gfps.de\/en\/wp-json\/wp\/v2\/comments?post=114375"}],"version-history":[{"count":2,"href":"https:\/\/www.gfps.de\/en\/wp-json\/wp\/v2\/pages\/114375\/revisions"}],"predecessor-version":[{"id":114377,"href":"https:\/\/www.gfps.de\/en\/wp-json\/wp\/v2\/pages\/114375\/revisions\/114377"}],"wp:attachment":[{"href":"https:\/\/www.gfps.de\/en\/wp-json\/wp\/v2\/media?parent=114375"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}