{"id":9662,"date":"2023-11-07T17:19:18","date_gmt":"2023-11-07T16:19:18","guid":{"rendered":"https:\/\/mpmedizintechnik.com\/products-services\/clean-room-production-medical-technology\/"},"modified":"2024-06-24T10:23:14","modified_gmt":"2024-06-24T08:23:14","slug":"clean-room-production-medical-technology","status":"publish","type":"page","link":"https:\/\/mpmedizintechnik.com\/en\/products-services\/clean-room-production-medical-technology\/","title":{"rendered":"Clean room production medical technology"},"content":{"rendered":"<section class=\"l-section wpb_row us_custom_d2c2c636 height_small width_full\"><div class=\"l-section-overlay\" style=\"background:#D6D8D8\"><\/div><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_middle type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-grid-none type_message\">No results found.<\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row us_custom_92b2762d height_auto\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-4 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"w-image align_none\"><div class=\"w-image-h\"><img decoding=\"async\" width=\"426\" height=\"426\" src=\"https:\/\/mpmedizintechnik.com\/wp-content\/uploads\/2024\/06\/medizin-von-morgen_en.svg\" class=\"attachment-large size-large\" alt=\"For the medicine of tomorrow Precision in steel Perfection in plastic Passion for health\" loading=\"lazy\" \/><\/div><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-8 wpb_column vc_column_container\"><div class=\"vc_column-inner us_custom_d8d12531\"><div class=\"wpb_wrapper\"><section class=\"l-section wpb_row us_custom_30e37d60 height_auto\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_top type_default stacking_default\"><div class=\"vc_col-sm-12 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><nav class=\"g-breadcrumbs separator_custom align_none\" itemscope itemtype=\"http:\/\/schema.org\/BreadcrumbList\"><div class=\"g-breadcrumbs-item\" itemscope itemprop=\"itemListElement\" itemtype=\"http:\/\/schema.org\/ListItem\"><a itemprop=\"item\" href=\"https:\/\/mpmedizintechnik.com\/en\/\"><span itemprop=\"name\">Home<\/span><\/a><meta itemprop=\"position\" content=\"1\"\/><\/div><div class=\"g-breadcrumbs-separator\">\u00bb<\/div><div class=\"g-breadcrumbs-item\">Pages<\/div><\/nav><\/div><\/div><\/div><\/div><\/div><\/section>\n<div class=\"w-separator size_small\"><\/div>[vc_custom_heading text=&#8221;Clean room production medical technology&#8221; font_container=&#8221;tag:h1|text_align:left&#8221; use_theme_fonts=&#8221;yes&#8221;]<div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><h3 style=\"color: #000000;\">Product development<\/h3>\n<p>Product development at Murrplastik Medizintechnik takes place under strict clean room conditions (ISO class 7) in the subsequent manufacturing process to ensure that the medical technology products manufactured meet the highest quality and hygiene standards. This ensures the safety and effectiveness of the injection molded components and assemblies produced.<\/p>\n<h4><strong>Concept and design<\/strong><\/h4>\n<p>Product development begins with the conception and design of new medical products. This includes the identification of requirements and specifications in close cooperation with medical experts and customers.<\/p>\n<h4>Material selection<\/h4>\n<p>Materials are selected that meet the high standards of medical technology. These materials must be biocompatible and sterilizable to ensure patient safety and product quality.<\/p>\n<h4>Risk management<\/h4>\n<p>The identification and assessment of risks is an important aspect for the validation of medical devices. This is a practiced process at Murrplastik Medizintechnik and helps to minimize potential hazards and implement risk mitigation measures.<br \/>\nPrototype development: Prototypes are needed to extensively test the functions and requirements in the production of the subsequent series articles under clean room conditions.<\/p>\n<h4>Validation<\/h4>\n<p>At the beginning, a comprehensive validation plan is drawn up that defines the specific objectives, methods, responsibilities and phases (DQ; IQ; OQ; PQ) for the validation. This plan is drawn up in accordance with the applicable regulations and standards (MDR; FDA: etc.).<\/p>\n<h4><strong>Documentation and certification<\/strong><\/h4>\n<p>All steps in the development and production process are carefully documented to ensure product traceability. In addition, the products are certified in accordance with the applicable regulations and standards (MDR; FDA; etc.).<\/p>\n<\/div><\/div><div class=\"w-separator size_small\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row height_small color_alternate\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_middle type_default stacking_default\"><div class=\"vc_col-sm-8 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><h2>3D printing of prototypes<\/h2>\n<p>3D printing of prototypes is a common practice in the medical technology and manufacturing industry. Murrplastik Medizintechnik uses 3D printing technologies to produce prototypes of future injection-molded components and assemblies. These prototypes are used for design testing, functional testing and product development purposes.<\/p>\n<\/div><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-4 wpb_column vc_column_container square has_bg_color stretched\"><div class=\"vc_column-inner us_custom_29a5cbae\"><div class=\"wpb_wrapper\"><div class=\"w-image img align_none\"><div class=\"w-image-h\"><img decoding=\"async\" width=\"596\" height=\"408\" src=\"https:\/\/mpmedizintechnik.com\/wp-content\/uploads\/2023\/11\/Drucker-3d-druck-Prototypen.jpg\" class=\"attachment-full size-full\" alt=\"3d-Druck von Prototypen Medizintechnik\" loading=\"lazy\" srcset=\"https:\/\/mpmedizintechnik.com\/wp-content\/uploads\/2023\/11\/Drucker-3d-druck-Prototypen.jpg 596w, https:\/\/mpmedizintechnik.com\/wp-content\/uploads\/2023\/11\/Drucker-3d-druck-Prototypen-300x205.jpg 300w, https:\/\/mpmedizintechnik.com\/wp-content\/uploads\/2023\/11\/Drucker-3d-druck-Prototypen-584x400.jpg 584w\" sizes=\"auto, (max-width: 596px) 100vw, 596px\" \/><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row height_small\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_flex valign_middle type_default stacking_default\"><div class=\"vc_col-sm-8 wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_wrapper\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><h2>Injection molding production in ISO class 7 clean room (EN ISO 14644)<\/h2>\n<h4>Production<\/h4>\n<p>The actual production of medical technology products takes place in ISO class 7 cleanrooms to prevent contamination. Employees wear special protective clothing and work under controlled conditions to ensure that the products are free from contamination.<\/p>\n<h4>Assembly<\/h4>\n<p>The assembly of injection-molded components into complete assemblies is carried out in compliance with the specific clean room conditions and according to precisely defined manufacturing guidelines. Murrplastik Medizintechnik has established assembly methods such as bonding, ultrasonic welding, laser marking and a variety of devices and testing technology.<\/p>\n<h4>Quality control<\/h4>\n<p>Strict quality control procedures are carried out throughout the production process to ensure that the products manufactured meet the specified standards and customer requirements. This includes, for example, tests for material integrity, dimensional accuracy and sterility.<\/p>\n<h4>Packaging and sterilization<\/h4>\n<p>The end products are packaged in ISO Class 7 cleanrooms and then sterilized by a long-standing external service provider to ensure that they are free of germs and contamination when they reach the customer.<\/p>\n<\/div><\/div><div class=\"w-separator size_medium\"><\/div><\/div><\/div><\/div><div class=\"vc_col-sm-4 wpb_column vc_column_container square has_bg_color stretched\"><div class=\"vc_column-inner us_custom_29a5cbae\"><div class=\"wpb_wrapper\"><div class=\"w-image img has_ratio align_none\"><div class=\"w-image-h\"><div style=\"padding-bottom:75%\"><\/div><img decoding=\"async\" width=\"800\" height=\"600\" src=\"https:\/\/mpmedizintechnik.com\/wp-content\/uploads\/2024\/06\/img_montage.webp\" class=\"attachment-full size-full\" alt=\"Reinraumfertigung Medizintechnik\" loading=\"lazy\" \/><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"No results found.Home\u00bbPages [vc_custom_heading text=\"Clean room production medical technology\" font_container=\"tag:h1|text_align:left\" use_theme_fonts=\"yes\"]Product development Product development at Murrplastik Medizintechnik takes place under strict clean room conditions (ISO class 7) in the subsequent manufacturing process to ensure that the medical technology products manufactured meet the highest quality and hygiene standards. This ensures the safety and effectiveness of the...","protected":false},"author":1,"featured_media":0,"parent":9656,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-9662","page","type-page","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/mpmedizintechnik.com\/en\/wp-json\/wp\/v2\/pages\/9662","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mpmedizintechnik.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mpmedizintechnik.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mpmedizintechnik.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mpmedizintechnik.com\/en\/wp-json\/wp\/v2\/comments?post=9662"}],"version-history":[{"count":6,"href":"https:\/\/mpmedizintechnik.com\/en\/wp-json\/wp\/v2\/pages\/9662\/revisions"}],"predecessor-version":[{"id":9672,"href":"https:\/\/mpmedizintechnik.com\/en\/wp-json\/wp\/v2\/pages\/9662\/revisions\/9672"}],"up":[{"embeddable":true,"href":"https:\/\/mpmedizintechnik.com\/en\/wp-json\/wp\/v2\/pages\/9656"}],"wp:attachment":[{"href":"https:\/\/mpmedizintechnik.com\/en\/wp-json\/wp\/v2\/media?parent=9662"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}