{"id":6727,"date":"2020-03-12T00:00:00","date_gmt":"2020-03-12T00:00:00","guid":{"rendered":"https:\/\/slcontrols.com\/case-study-design-and-implement-a-udi-and-batch-integrity-system-in-a-complex-medical-device-production-facility\/"},"modified":"2021-10-15T09:49:08","modified_gmt":"2021-10-15T09:49:08","slug":"case-study-design-and-implement-a-udi-and-batch-integrity-system-in-a-complex-medical-device-production-facility","status":"publish","type":"post","link":"https:\/\/www.slcontrols.k8s-stg1-global.sq1.io\/en\/case-study-design-and-implement-a-udi-and-batch-integrity-system-in-a-complex-medical-device-production-facility\/","title":{"rendered":"Case Study: Design and Implement a UDI and Batch Integrity System in a Complex Medical Device Production Facility"},"content":{"rendered":"<p>Equipment systems integration solutions are becoming increasingly important in medical device and pharmaceutical production facilities. There are several reasons for this including changing regulatory requirements, the need to improve the service offered to patients\/users, and the need to remain competitive by making efficiency savings and increasing productivity.<\/p>\n<p>These were some of the motivating factors for our client, a medical device manufacturer, in its decision to implement the <a href=\"https:\/\/slcontrols.com\/equipment-systems-integration\/\">Equipment Systems Integration<\/a> project covered in this case study.<\/p>\n<h2>Objectives<\/h2>\n<p>The project involved introducing a <a href=\"https:\/\/slcontrols.com\/the-udi-and-serialisation-requirements-of-the-new-eu-mdr\/\">Unique Device Identification (UDI) system<\/a> on each line in its production facility. This new system needed to identify every product produced, a key requirement of FDA regulations as well as the new EU MDR (Medical Device Regulations) that is being implemented in May 2020.<\/p>\n<p>Another requirement of the project was to introduce a <a href=\"https:\/\/slcontrols.com\/data-integrity-in-the-manufacturing-process\/\">Batch Integrity system<\/a> on each line to ensure the integrity of all production line cells.<\/p>\n<p>As a result, improving customer service levels and quality control in addition to making efficiency savings were also key priorities, among other things.<\/p>\n<h2>What We Did<\/h2>\n<p>Our client as approximately 50 medical device production and packaging lines in a single facility. The processes on those lines include automated assembly, sterilisation, and packaging.<\/p>\n<p>The solution we developed included:<\/p>\n<ul>\n<li>Line clearance and purge systems<\/li>\n<li>Batch management control systems<\/li>\n<li>Quality control systems<\/li>\n<li>Verification systems<\/li>\n<\/ul>\n<p>The solution also needed to be fully integrated with the customer\u2019s ERP. All systems needed a GAMP 5 validation package and the solution needed to be 21CFR11 compliant.<\/p>\n<h2>Results<\/h2>\n<p>The solution we implemented met all customer requirements and now controls full data management on all lines. This includes managing the transfer of data to the equipment, identification, and verification systems, something that is a key part of the majority of Equipment Systems Integration projects.<\/p>\n<p>The system we implemented also included a user interface that lets engineers and technicians create line clearance and purge interlocks as well as product changeover controls for batch management.<\/p>\n<p>In addition, the system controls printers, vision verification systems, and batch parameters, plus it logs all batch details of the product.<\/p>\n<p>To find out more and to discuss an Equipment System Integration project you are planning, please <a href=\"https:\/\/slcontrols.com\/contact-sl-controls\/\">contact us at SL Controls today<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Equipment systems integration solutions are becoming increasingly important in medical device and pharmaceutical production facilities. There are several reasons for this including changing regulatory requirements, the need to improve the service offered to patients\/users, and the need to remain competitive by making efficiency savings and increasing productivity. These were some of the motivating factors for &hellip;<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/www.slcontrols.k8s-stg1-global.sq1.io\/en\/case-study-design-and-implement-a-udi-and-batch-integrity-system-in-a-complex-medical-device-production-facility\/\"> <span class=\"screen-reader-text\">Case Study: Design and Implement a UDI and Batch Integrity System in a Complex Medical Device Production Facility<\/span> Read More &raquo;<\/a><\/p>\n","protected":false},"author":61,"featured_media":2655,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"site-sidebar-layout":"default","site-content-layout":"default","ast-global-header-display":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","footnotes":""},"categories":[95],"tags":[],"class_list":["post-6727","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Case Study: Design and Implement a UDI and Batch Integrity System in a Complex Medical Device Production Facility - SL Controls<\/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.slcontrols.k8s-stg1-global.sq1.io\/en\/case-study-design-and-implement-a-udi-and-batch-integrity-system-in-a-complex-medical-device-production-facility\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Case Study: Design and Implement a UDI and Batch Integrity System in a Complex Medical Device Production Facility - SL Controls\" \/>\n<meta property=\"og:description\" content=\"Equipment systems integration solutions are becoming increasingly important in medical device and pharmaceutical production facilities. There are several reasons for this including changing regulatory requirements, the need to improve the service offered to patients\/users, and the need to remain competitive by making efficiency savings and increasing productivity. These were some of the motivating factors for &hellip; Case Study: Design and Implement a UDI and Batch Integrity System in a Complex Medical Device Production Facility Read More &raquo;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.slcontrols.k8s-stg1-global.sq1.io\/en\/case-study-design-and-implement-a-udi-and-batch-integrity-system-in-a-complex-medical-device-production-facility\/\" \/>\n<meta property=\"og:site_name\" content=\"SL Controls\" \/>\n<meta property=\"article:published_time\" content=\"2020-03-12T00:00:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-10-15T09:49:08+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.slcontrols.k8s-stg1-global.sq1.io\/wp-content\/uploads\/2021\/03\/Case-Study-Design-and-Implement-a-UDI-and-Batch-Integrity-System-in-a-Complex-Medical-Device-Production-Facility.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"628\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Mick McHale\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mick McHale\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.slcontrols.k8s-stg1-global.sq1.io\/en\/case-study-design-and-implement-a-udi-and-batch-integrity-system-in-a-complex-medical-device-production-facility\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.slcontrols.k8s-stg1-global.sq1.io\/en\/case-study-design-and-implement-a-udi-and-batch-integrity-system-in-a-complex-medical-device-production-facility\/\"},\"author\":{\"name\":\"Mick McHale\",\"@id\":\"https:\/\/www.stg.slcontrols.com.sq1.io\/#\/schema\/person\/817ad183e077eb975d3fe80f7cc440da\"},\"headline\":\"Case Study: Design and Implement a UDI and Batch Integrity System in a Complex Medical Device Production Facility\",\"datePublished\":\"2020-03-12T00:00:00+00:00\",\"dateModified\":\"2021-10-15T09:49:08+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.slcontrols.k8s-stg1-global.sq1.io\/en\/case-study-design-and-implement-a-udi-and-batch-integrity-system-in-a-complex-medical-device-production-facility\/\"},\"wordCount\":384,\"publisher\":{\"@id\":\"https:\/\/www.stg.slcontrols.com.sq1.io\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.slcontrols.k8s-stg1-global.sq1.io\/en\/case-study-design-and-implement-a-udi-and-batch-integrity-system-in-a-complex-medical-device-production-facility\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/img.slcontrols.k8s-stg1-global.sq1.io\/wp-content\/uploads\/2021\/03\/Case-Study-Design-and-Implement-a-UDI-and-Batch-Integrity-System-in-a-Complex-Medical-Device-Production-Facility.jpg\",\"articleSection\":[\"News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.slcontrols.k8s-stg1-global.sq1.io\/en\/case-study-design-and-implement-a-udi-and-batch-integrity-system-in-a-complex-medical-device-production-facility\/\",\"url\":\"https:\/\/www.slcontrols.k8s-stg1-global.sq1.io\/en\/case-study-design-and-implement-a-udi-and-batch-integrity-system-in-a-complex-medical-device-production-facility\/\",\"name\":\"Case Study: Design and Implement a UDI and Batch Integrity System in a Complex Medical Device Production Facility - 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