{"id":1275,"date":"2024-10-30T13:00:44","date_gmt":"2024-10-30T04:00:44","guid":{"rendered":"https:\/\/cm-plus.co.jp\/id\/?post_type=column&#038;p=1275"},"modified":"2025-05-02T15:07:04","modified_gmt":"2025-05-02T06:07:04","slug":"dx_technology2","status":"publish","type":"column","link":"https:\/\/cm-plus.co.jp\/id\/column\/plant_dx_itot\/dx_technology2\/","title":{"rendered":"Application of DX Technology in Pharmaceutical Manufacturing 2"},"content":{"rendered":"<p>In the previous issue, we discussed the overall roadmap for DX (Digital Transformation) and organized the control system hierarchy.<\/p>\n<div id=\"toc_container\" class=\"toc\"><p class=\"toc_title\">Table of Contents<\/p><ul class=\"toc-list\"><li><a href=\"#toc1\"><span class=\"toc_number\">1<\/span> Approach to DX Implementation<\/a><\/li><li><a href=\"#toc2\"><span class=\"toc_number\">2<\/span> Clarification of the Issues<\/a><\/li><li><a href=\"#toc3\"><span class=\"toc_number\">3<\/span> Steps in Digital Data DX<\/a><\/li><li><a href=\"#toc4\"><span class=\"toc_number\">4<\/span> Case Studies of Digital Technology Implementation<\/a><\/li><li><a href=\"#toc6\"><span class=\"toc_number\">5<\/span> Steps of Digital Data DX<\/a><\/li><\/ul><\/div>\n\n<h2 class=\"headLine05\">Approach to DX Implementation<\/h2>\n<p>DX Implementation Approach<br \/>\nCM Plus proposes a DX implementation approach.<br \/>\nIn order to ensure a solid digitalization process, the first step is to clarify what you want to do and organize your requirements. We will organize the main issues to be solved related to the project&#8217;s external environment, equipment, and production operations, the data collection methods needed to solve them, and the requirements for digitization and systemization of the data collection methods. Next, a list of candidate digital data and packaged systems and tools that contribute to digitization and smartening is compiled and prioritized in light of the above DX requirements. Then, based on the above, a basic concept of digitalization, digital technology, and IT\/OT implementation will be developed based on the possible DX levels of digital data collection, sharing\/visualization\/analysis, and forecasting\/learning\/automation as indicated above.<\/p>\n<p class=\"has-text-align-center imgTtl\">Fig.1 Approach to DX Implementation<\/p>\n<figure class=\"pop-pc pop-sp\">\n<div class=\"photo\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-5047\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/05\/dx_technology2_img1-1.jpg\" alt=\"\" width=\"1200\" height=\"537\" srcset=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/05\/dx_technology2_img1-1.jpg 1200w, https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/05\/dx_technology2_img1-1-300x134.jpg 300w, https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/05\/dx_technology2_img1-1-1024x458.jpg 1024w, https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/05\/dx_technology2_img1-1-768x344.jpg 768w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/><\/div>\n<\/figure>\n<h2 class=\"headLine05\">Clarification of the Issues<\/h2>\n<p>As stated in the previous Column Fig.2, DX on Digital Data (DX Progress Level &#8211; Expected Effectiveness), we believe it is most important to clarify what the goal is and the purpose of technology implementation.<\/p>\n<p class=\"has-text-align-center imgTtl\">Table 1: List of Technology Implementation Objectives<\/p>\n<table>\n<tbody>\n<tr>\n<th>Man (&amp; Management)<\/th>\n<td>\n<ul class=\"comRaiList\">\n<li>Man Power Saving<\/li>\n<li>Labour Saving<\/li>\n<li>Visualization<\/li>\n<li>Elimination of specific human resources<\/li>\n<li>(prevention of personal variation and errors, equalization of specific individual technologies)<\/li>\n<li>Safety Improvement<\/li>\n<li>e-Training (Onsite\/Offline) , Record<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr>\n<th>Machine &amp; Material<\/th>\n<td>\n<ul class=\"comRaiList\">\n<li>Improvement in efficiency<\/li>\n<li>Increasing productivity<\/li>\n<li>Quality Improvement<\/li>\n<li>Failure Reduction<\/li>\n<li>Improvement in operating ratio<\/li>\n<li>Cost down<\/li>\n<li>Prevention of leakage and contamination<\/li>\n<li>Traceability and serialization support<\/li>\n<li>Preventive Maintenance, Predictive Maintenance<\/li>\n<li>Remote Maintenance<\/li>\n<li>Data Input, Process, Analytics<\/li>\n<li>Process and material handling automation<\/li>\n<li>Continuous Production<\/li>\n<li>PAT(Process Analytical Technology)<\/li>\n<li>Energy Saving, Zero Emissions, Carbon Neutral<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<tr>\n<th>Method (&amp; Managemant)<\/th>\n<td>\n<ul class=\"comRaiList\">\n<li>Paperless system<\/li>\n<li>Audit support<\/li>\n<li>Risk Assessment<\/li>\n<li>Data Input, Process, Analytics<\/li>\n<li>e-SOP<\/li>\n<li>MBR, EBR<\/li>\n<li>e-Training (Onsite\/Offline) , Record<\/li>\n<\/ul>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2 class=\"headLine05\">Steps in Digital Data DX<\/h2>\n<p>We believe that it is possible to solve problems by taking the approach of implementing individual systems and tools to achieve the issues, objectives, and goals in each step of digital data collection, sharing\/visualization\/analysis, and prediction\/learning\/automation.<\/p>\n<p class=\"has-text-align-center imgTtl\">Fig.2 Steps in Digital Data DX (System Selection)<\/p>\n<figure class=\"pop-pc pop-sp\">\n<div class=\"photo\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-4855\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/05\/dx_technology2_img2.png\" alt=\"\" width=\"892\" height=\"395\" srcset=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/05\/dx_technology2_img2.png 892w, https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/05\/dx_technology2_img2-300x133.png 300w, https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/05\/dx_technology2_img2-768x340.png 768w\" sizes=\"auto, (max-width: 892px) 100vw, 892px\" \/><\/div>\n<\/figure>\n<p>Al:Artificial Inteligence<br \/>\nML:Machine Learning<\/p>\n<h2 class=\"headLine05\">Case Studies of Digital Technology Implementation<\/h2>\n<p>The following are examples of digital technology implementation cases in which we have been involved.<br \/>\nIn each case, we have assisted in the creation of deliverables and the formulation of specifications at each stage by taking the following approaches: &#8220;Clarification of issues to be addressed,&#8221; &#8220;Survey and selection of available tools and systems,&#8221; and &#8220;Building-up the Overall system conception&#8221;.<br \/>\nWe also published books and launched &#8220;IVEXL&#8221; internet platform, which we hope you will take a look at when you have a chance.<\/p>\n<div class=\"comTextArea\">\n<div class=\"area\">\n<h4 class=\"headLine10\">\uff1cCase Studies of our DX Support Services\uff1e<\/h4>\n<div class=\"comImgBox\">\n<div class=\"photoBox\"><a href=\"\/en\/news\/event\/2023_0609\/\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-4856\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/05\/dx_technology2_img3.png\" alt=\"\" width=\"209\" height=\"307\" srcset=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/05\/dx_technology2_img3.png 209w, https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/05\/dx_technology2_img3-204x300.png 204w\" sizes=\"auto, (max-width: 209px) 100vw, 209px\" \/><\/a><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-3196\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/04\/IVEXL_logo.png\" alt=\"\" width=\"531\" height=\"163\" srcset=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/04\/IVEXL_logo.png 531w, https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/04\/IVEXL_logo-300x92.png 300w\" sizes=\"auto, (max-width: 531px) 100vw, 531px\" \/><\/div>\n<div class=\"textBox\">\n<ul class=\"comRaiList\">\n<li>Food Industry<br \/>\n\u2192New Factory FS,CD\u3000Digital Technology Investigation, Conceptual Design<\/li>\n<li>Polymeric Bulk Pharmaceutical Plant<br \/>\n\u2192New Plant Basic Design\u3000Preparation of construction inquiry documents (ITOT outline and control specifications)<\/li>\n<li>APIs Plant<br \/>\n\u2192New Plant Basic Design Preparation of construction inquiry documents (control overview and system diagrams)<\/li>\n<li>Low-molecular-weight bulk pharmaceutical<br \/>\n\u2192New Plant Basic Design Preparation of construction inquiry documents (control system outline)<\/li>\n<li>\u201cHow to Build a Pharmaceutical Plant\u201d(to be published in July 2023)<br \/>\n\u2192Partial control, referring to DX<\/li>\n<li>Sponsored by \u201ciVEXL\u201d<br \/>\n\u2192Providing a web-based digital exhibition platform for life sciences<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>FS\uff1aFeasibility Study<br \/>\nCD\uff1aConcept Design<br \/>\nBD\uff1aBasic Design<\/p>\n<h2 class=\"headLine05\">Steps of Digital Data DX<\/h2>\n<p>Based on the stages of technology implementation and DX realization levels described above, we propose the following steps for DX implementation in pharmaceutical plants: 1. In order to realize this one-stop solution, we need advanced engineering, project management, GMP consulting, and system integration capabilities for pharmaceutical plant construction projects. CM Plus has all of these capabilities. We are not a specialized system integrator, but rather participate in projects as an owner&#8217;s consultant, acting on behalf of the client. We have a team of PM, EM, CM, VM, GMP regulatory consulting, and GMP training for projects in the life science business.<\/p>\n<p class=\"has-text-align-center imgTtl\">Proposal from CM Plus Corp.<\/p>\n<figure class=\"pop-pc pop-sp\">\n<div class=\"photo\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-5040 size-full\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/07\/dx_technology2_img4.jpg\" alt=\"\" width=\"1009\" height=\"536\" srcset=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/07\/dx_technology2_img4.jpg 1009w, https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/07\/dx_technology2_img4-300x159.jpg 300w, https:\/\/cm-plus.co.jp\/id\/wp-content\/uploads\/2024\/07\/dx_technology2_img4-768x408.jpg 768w\" sizes=\"auto, (max-width: 1009px) 100vw, 1009px\" \/><\/div>\n<\/figure>\n<div class=\"comApplyBox\">\n<p class=\"ttl\">If you need help with DX for your pharmaceutical factory, please feel free to contact us.<\/p>\n<div class=\"comApplyLink\"><a href=\"https:\/\/cm-plus.co.jp\/id\/contact_us\/\"><span class=\"sub\"><img decoding=\"async\" src=\"https:\/\/cm-plus.co.jp\/id\/wp-content\/themes\/cmplus\/image\/common\/icon-mail.webp\" alt=\"Contact us about DX for your pharmaceutical factory\" width=\"20\" \/>Contact us about DX for your pharmaceutical factory<\/span><\/a><\/div>\n<\/div>\n","protected":false},"featured_media":5338,"template":"","columncat":[44],"columntag":[46,47],"keywords":[],"class_list":["post-1275","column","type-column","status-publish","has-post-thumbnail","hentry","columncat-plant_dx_itot","columntag-dx","columntag-itot"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Application of DX Technology in Pharmaceutical Manufacturing 2\uff5cCM Plus<\/title>\n<meta name=\"description\" content=\"DX in Factories (DI Initiatives and Big Data Utilization)\" \/>\n<meta name=\"robots\" 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