{"id":5209,"date":"2018-06-30T08:55:22","date_gmt":"2018-06-30T08:55:22","guid":{"rendered":"https:\/\/staging.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:\/\/staging.amb.se\/en\/cleanroom-production\/","title":{"rendered":"Cleanroom production"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><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][spacer height=&#8221;20&#8243;][vc_column_text]<\/p>\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<p>[\/vc_column_text][faq category=&#8221;cleanroom-production&#8221;][spacer height=&#8221;20&#8243;][callout title=&#8221;Contacts&#8221; link=&#8221;https:\/\/staging.amb.se\/en\/contacts\/&#8221;]Know more?[\/callout][spacer height=&#8221;40&#8243;][\/vc_column][\/vc_row]<\/p>\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][spacer height=&#8221;20&#8243;][vc_column_text] Clean room production What is cleanroom production? 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 [&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=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\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][spacer height=&#8221;20&#8243;][vc_column_text] Clean room production What is cleanroom production? 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. 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