{"id":5209,"date":"2018-06-30T08:55:22","date_gmt":"2018-06-30T08:55:22","guid":{"rendered":"https:\/\/amb.se\/?page_id=5209"},"modified":"2023-11-27T15:50:25","modified_gmt":"2023-11-27T15:50:25","slug":"cleanroom-production","status":"publish","type":"page","link":"https:\/\/amb.se\/en\/cleanroom-production\/","title":{"rendered":"Cleanroom production"},"content":{"rendered":"<div class=\"wpb-content-wrapper\">[vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; top_margin=&#8221;0&#8243; bottom_margin=&#8221;0&#8243; css=&#8221;.vc_custom_1509551730213{margin-bottom: -1px !important;padding-top: 30px !important;padding-bottom: 30px !important;background-color: #ffffff !important;}&#8221;][vc_column]<div class=\"shortcode-wrapper shortcode-spacer clearfix\"><div class=\"spacer\" style=\"height:20px;\"><\/div><\/div>[vc_column_text]\n<h1 style=\"font-size: 36px; color: #990000;\">Clean room production<\/h1>\n<h2>What is cleanroom production?<\/h2>\n<p>In many cases, an essential condition for manufacturing medical devices and components is for them to be made in a strictly controlled environment, usually known as a cleanroom. Cleanrooms are divided into different cleanliness classes according to ISO standard 14644-1, which concerns the classification of air cleanliness by particle concentration in room air and how this must be measured. Achieving a production environment that meets the standard\u2019s particle concentration requirements places great demands on the quality of rooms, equipment and practices.<\/p>\n<p>Basic conditions include the following:<\/p>\n<ul>\n<li>Rooms subject to positive pressure and a ventilation system that provides many air changes with highly filtered air.<\/li>\n<li>Ceilings, walls and floors must be easy to clean.<\/li>\n<li>Tools such as injection moulders and other equipment must be designed and adapted to shed a minimum of particles and other contaminants while also being easy to clean and maintain.<\/li>\n<li>Access for personnel and materials only takes place through airlocks.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>Producing medical components in a cleanroom also means that such things as inbound materials handling, equipment maintenance, personnel training and quality control of components or products manufactured are subject to GMP procedures and ISO 13485:2016.<\/p>\n<h2>AMB\u2019s cleanroom capabilities<\/h2>\n<p>In addition to the components intended for medical equipment that are often produced in our regular facilities, we also offer injection moulding, assembly and sterile packaging of single-use medical devices in cleanrooms. We perform assembly and packaging both manually and in highly automated processes, depending on the needs of the project concerned.<\/p>\n<p>Our first cleanroom was completed in 2008 and is validated to class 8, which according to ISO standard 14644-1 means that the number of particles larger than 0.0005 mm must be fewer than 3.5 million per cubic metre of air. Class 8 is the most widely used cleanroom purity level for the production of components and products that must undergo a sterilisation process after assembly and packaging.<\/p>\n<p>During 2018 we completed our second cleanroom, with a total of 1000 m\u00b2 production floor space in a class 8 cleanroom environment.<\/p>\n<h2>FAQ:<\/h2>\n[\/vc_column_text]<div class=\"faq-module-wrapper\">\t\t\t\t<div id=\"what-is-positive-pressure\" class=\"hb-toggle cleanroom-production\">\n\t\t\t\t\t<div class=\"hb-accordion-single\">\n\n\t\t\t\t\t\t<div class=\"hb-accordion-tab\">\n\t\t\t\t\t\t\t<i class=\"hb-moon-plus-circle\"><\/i>\n\t\t\t\t\t\t\tWhat is positive pressure?\t\t\t\t\t\t\t<i class=\"icon-angle-right\"><\/i>\n\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t<div class=\"hb-accordion-pane\" style=\"display: none;\">\n\t\t\t\t\t\t\t<div class=\"wpb-content-wrapper\">[vc_row][vc_column][vc_column_text]<span style=\"font-weight: 400;\">Air pressure, or atmospheric pressure, atm, is a pressure unit of 101.325 kPa, which roughly corresponds to the average normal atmospheric pressure at sea level.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Positive pressure is the pressure within a system that is greater than the environment surrounding the system. If there are openings that allow a leak from a pressurized room, the air will escape into the surrounding environment. To prevent airborne microorganisms such as bacteria etc. from entering the room, an overpressure of purified air prevails in clean rooms where the air is allowed to escape from the room in a controlled manner.<\/span>[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div><div class=\"shortcode-wrapper shortcode-spacer clearfix\"><div class=\"spacer\" style=\"height:20px;\"><\/div><\/div><div class=\"shortcode-wrapper shortcode-callout clearfix\"><div class=\"hb-callout-box\"><h3 class=\"\">Know more?<\/h3><a href=\"https:\/\/amb.se\/en\/contacts\/\" class=\"hb-button\"no>Contacts<\/a><\/div><\/div><div class=\"shortcode-wrapper shortcode-spacer clearfix\"><div class=\"spacer\" style=\"height:40px;\"><\/div><\/div>[\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; top_margin=&#8221;0&#8243; bottom_margin=&#8221;0&#8243; css=&#8221;.vc_custom_1509551730213{margin-bottom: -1px !important;padding-top: 30px !important;padding-bottom: 30px !important;background-color: #ffffff !important;}&#8221;][vc_column][vc_column_text] Clean room production What is cleanroom production? In many cases, an essential condition for manufacturing [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4976,"parent":0,"menu_order":20,"comment_status":"closed","ping_status":"closed","template":"","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-5209","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Clean room production - AMB<\/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:\/\/amb.se\/en\/cleanroom-production\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clean room production - AMB\" \/>\n<meta property=\"og:description\" content=\"[vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; content_placement=&#8221;middle&#8221; top_margin=&#8221;0&#8243; bottom_margin=&#8221;0&#8243; css=&#8221;.vc_custom_1509551730213{margin-bottom: -1px !important;padding-top: 30px !important;padding-bottom: 30px !important;background-color: #ffffff !important;}&#8221;][vc_column][vc_column_text] Clean room production What is cleanroom production? 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