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Pharma 4.0 ™ to attain a fully automated and interconnected production unit",{"rendered":507,"protected":508},"\n\u003Cp>This transition allowed the client to set up a smart factory as per \u003Ca href=\"https:\u002F\u002Fispe.org\u002Finitiatives\u002Fpharma-4.0\">the Pharma 4.0 ™ initiative\u003C\u002Fa> launched by the International Society for Pharmaceutical Engineering (ISPE).\u003C\u002Fp>\n\n\n\u003Ch4 class=\"wp-block-heading\" id=\"h-the-context\">\u003Cstrong>The context\u003C\u002Fstrong>\u003C\u002Fh4>\n\n\n\u003Cp>The client is a multinational biopharmaceutical firm that required assistance setting up its new production unit in Belgium. This production unit had to be fully automated, according to the Pharma 4.0™ standards.\u003C\u002Fp>\n\n\n\n\u003Cp>Most industrial sectors are experiencing a rapid advancement towards implementing industry 4.0 technologies. This leads to greater operational efficiency and increased competitive advantage. Pharmaceutical manufacturing is no exception to this trend.\u003C\u002Fp>\n\n\n\n\u003Cp>The pharmaceutical industry is, however, subjected to much stricter regulatory laws. Thus, transformation to Pharma 4.0 ™ or smart factories is relatively slower and more complex.\u003C\u002Fp>\n\n\n\n\u003Cp>CBTW was able to meet the high standards of regulation in the pharmaceutical sector, such as the \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdevelopment-approval-process-drugs\u002Fpharmaceutical-quality-resources\">FDA\u003C\u002Fa> and \u003Ca href=\"https:\u002F\u002Fwww.ema.europa.eu\u002Fen\u002Fhuman-regulatory\u002Fresearch-development\u002Fcompliance\u002Fgood-manufacturing-practice#:~:text=Good%20manufacturing%20practice%20(GMP)%20describes,European%20Union%20(EU)%20level.\">GMP\u003C\u002Fa> regulations. Moreover, important requirements such as data integrity, documentation, and processes met the FDA regulatory compliance and the GMP practices authorization.\u003C\u002Fp>\n\n\n\n\u003Cp>Furthermore, we helped the client to build the production unit from scratch and standardize the production and cleaning process (CIP). To add to that, the automation process and the evaluation of the automation code was done according to the ISA 88 regulation of automation.\u003C\u002Fp>\n\n\n\u003Ch4 class=\"wp-block-heading\" id=\"h-challenges-of-our-client-in-the-pharmaceutical-industry\">\u003Cstrong>Challenges of our client in the pharmaceutical industry\u003C\u002Fstrong>\u003C\u002Fh4>\n\n\n\u003Cul class=\"wp-block-list\">\n\u003Cli>Equipment not standardized and coming from different parties: Various parties such as the supplier, manufacturer, and SME (subject matter experts) reviewed and confirmed the processes and equipment used. In addition, they needed standardization for the P&IDs, because each valve, pipe, or other equipment came from different suppliers. Therefore, in order to achieve standardization, the entire process including interaction of each piece of equipment had to be adapted as per the desire of the client.\u003C\u002Fli>\n\n\n\n\u003Cli>Equipment not readable for automation: Building the automation philosophy. It was necessary to modify and improve the design of piping and ­­adapt the Piping and Instrumentation Diagrams (P&IDs) such that it was readable for automation. Furthermore, adjust and modify to­­ verify valves interaction with each other in a standardized manner.\u003C\u002Fli>\n\n\n\n\u003Cli>Non-uniformed automation philosophy: Adjusting the automation philosophy, tailored for client’s needs. We organized the process of Functional Description Specification (FDS) where the code was further standardized and adapted. \u003C\u002Fli>\n\n\n\n\u003Cli>Meeting the high standard regulations for cleaning efficiency: Implementation of standardized cleaning practices. Implemented to maximize cleaning efficiency and meet the standards, as dictated by \u003Ca href=\"https:\u002F\u002Fstatics.teams.cdn.office.net\u002Fevergreen-assets\u002Fsafelinks\u002F1\u002Fatp-safelinks.html\">the regulations of the FDA’s ‘best cleaning practices’\u003C\u002Fa>, in addition, the process, connected to the MAIN USER SYSTEM, and automated. Evidently, this aspect is one of the main challenges for many firms as the equipment was from different suppliers and had to be brought to common grounds.\u003C\u002Fli>\n\u003C\u002Ful>\n\n\n\u003Ch4 class=\"wp-block-heading\" id=\"h-our-approach-towards-implementing-pharma-4-0\">\u003Cstrong>Our approach towards Implementing Pharma 4.0 ™\u003C\u002Fstrong>\u003C\u002Fh4>\n\n\n\u003Cp>\u003Cem>The detailed solution-based approach to each challenge\u003C\u002Fem>\u003C\u002Fp>\n\n\n\u003Ch3 class=\"wp-block-heading\" id=\"h-1-accomplishing-standardization\">1. Accomplishing standardization\u003C\u002Fh3>\n\n\n\u003Cp>To accomplish standardization, we built P&IDs to dictate exactly how each piece of equipment should function, interact, act, clean, produce, and sterilize. Moreover, we also helped to alter and improve the P&IDs until it met the client’s needs.\u003C\u002Fp>\n\n\n\u003Ch3 class=\"wp-block-heading\" id=\"h-2-building-the-automation-philosophy-from-scratch\">\u003Cstrong>2. Building the automation philosophy from scratch\u003C\u002Fstrong>\u003C\u002Fh3>\n\n\n\u003Cp>\u003Cstrong>Step A\u003C\u002Fstrong>\u003C\u002Fp>\n\n\n\n\u003Cp>The approach adopted in building the automation was to break down the units into smaller, efficient, and manageable modules:\u003C\u002Fp>\n\n\n\n\u003Cul class=\"wp-block-list\">\n\u003Cli>Smaller module called control modules (consists of a few components) tested, automated and validated appropriately.\u003C\u002Fli>\n\n\n\n\u003Cli>After accomplishing this, a block connected to other blocks to form a larger one called the Equipment Module (EM).\u003C\u002Fli>\n\n\n\n\u003Cli>Afterwards, multiple EMs, fully automated and inter-connected to form a unit.\u003C\u002Fli>\n\u003C\u002Ful>\n\n\n\n\u003Cp>The units are, as a result, now fully automated. This method allows for a ground-up approach to the development and validation of the process for automation.\u003C\u002Fp>\n\n\n\n\u003Cp>The automation was achieved, as per the FDA regulation for automation, highly recognized as the ISA 88 Standard for automation.\u003C\u002Fp>\n\n\n\n\u003Cp>The two main advantages are:\u003C\u002Fp>\n\n\n\n\u003Cul class=\"wp-block-list\">\n\u003Cli>It allowed the client to pass the regulation check and be certified to sell globally.\u003C\u002Fli>\n\n\n\n\u003Cli>The client could produce most efficiently, and future alterations can be made with minimal difficulty.\u003C\u002Fli>\n\u003C\u002Ful>\n\n\n\n\u003Cp>\u003Cstrong>STEP B\u003C\u002Fstrong>\u003C\u002Fp>\n\n\n\n\u003Cp>Through the integration of Siemens PCS7, digital maturity was attained. More specifically, the production unit is now interconnected, monitored, fully automated, and controlled centrally.\u003C\u002Fp>\n\n\n\u003Ch3 class=\"wp-block-heading\" id=\"h-3-reviewing-functional-description-specification-fds\">\u003Cstrong>3. Reviewing Functional Description Specification (FDS)\u003C\u002Fstrong>\u003C\u002Fh3>\n\n\n\u003Cp>FDS is a written document on the function of each automation philosophy. Since the project consisted of inputs from various suppliers, it was essential to constantly evaluate each process at play. Hence, sessions of RFIs (Responses for Information) were often organized for evaluation.\u003C\u002Fp>\n\n\n\n\u003Cp>Furthermore, we assisted in bringing the various parties on the same level and building the framework for standardized automation for the entire production unit.\u003C\u002Fp>\n\n\n\u003Ch3 class=\"wp-block-heading\" id=\"4nbspstandardized-cip\">4. \u003Cstrong>Standardized CIP\u003C\u002Fstrong>\u003C\u002Fh3>\n\n\n\u003Cp>The 2nd aspect of the project in which we assisted the client was the cleaning. In the pharmaceutical industry, cleaning is a crucial part of the entire process. The vessels and pipes were, again, from different suppliers, but were all adjusted to have a \u003Cstrong>common standard\u003C\u002Fstrong> for cleaning purposes. Increasing cleaning efficiency and allowing the project to pass the ‘\u003Cstrong>best cleaning practice\u003C\u002Fstrong>‘ as per FDA regulations.\u003C\u002Fp>\n\n\n\n\u003Cp>An example, is the ‘\u003Cstrong>Caustic Standard’\u003C\u002Fstrong> pace. Standard pace advised by th­e FDA regulation.\u003C\u002Fp>\n\n\n\u003Ch2 class=\"wp-block-heading\" id=\"Results-of-Pharma-4.0\">Results of implementing Pharma 4.0 ™\u003C\u002Fh2>\n\n\u003Ch3 class=\"wp-block-heading\" id=\"results\">Results\u003C\u002Fh3>\n\n\n\u003Cp>Overall, reliable standardization and implementation of \u003Ca href=\"https:\u002F\u002Fotofacto.tech\u002Fexpertise\u002Fsmart-automation\u002F\" target=\"_blank\" rel=\"noreferrer noopener\">autonomous automating systems \u003C\u002Fa>was achieved. The production unit, wholly interconnected with its processes streamlined!\u003C\u002Fp>\n\n\n\n\u003Cp>Thus, leading to the following advantages:\u003C\u002Fp>\n\n\n\n\u003Cul class=\"wp-block-list\">\n\u003Cli>\u003Cstrong>Improved control of operations\u003C\u002Fstrong>\u003C\u002Fli>\n\n\n\n\u003Cli>\u003Cstrong>Reduced production variability\u003C\u002Fstrong>\u003C\u002Fli>\n\n\n\n\u003Cli>\u003Cstrong>An increase in precision\u003C\u002Fstrong>\u003C\u002Fli>\n\n\n\n\u003Cli>\u003Cstrong>Reduction in error \u003C\u002Fstrong>\u003C\u002Fli>\n\n\n\n\u003Cli>\u003Cstrong>Reduced human reliance\u003C\u002Fstrong>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\n\u003Ch3 class=\"wp-block-heading\" id=\"conclusion\">Conclusion\u003C\u002Fh3>\n\n\n\u003Cp>To sum it up, the project allowed the client to attain \u003Ca href=\"https:\u002F\u002Fotofacto.tech\u002Finsights\u002Findustry-4-0-maturity-check\u002F\" target=\"_blank\" rel=\"noreferrer noopener\">digital maturity\u003C\u002Fa> through increased \u003Cstrong>control, \u003C\u002Fstrong>laying the foundation to \u003Ca href=\"https:\u002F\u002Fotofacto.tech\u002Finsights\u002Fdigital-transformation-strategy-roadmap-digital-core-team\u002F\" target=\"_blank\" rel=\"noreferrer noopener\">build future digital transformation strategies\u003C\u002Fa>, which can potentially utilize other technologies from \u003Ca href=\"https:\u002F\u002Fwww.ibm.com\u002Ftopics\u002Findustry-4-0\" target=\"_blank\" rel=\"noreferrer noopener\">Industry 4.0\u003C\u002Fa>.\u003C\u002Fp>\n\n\n\n\u003Cp>Inevitably, thanks to the project, our client achieved a strong \u003Cstrong>competitive edge\u003C\u002Fstrong> thanks to the improved product quality, and reduced costs in the long run. Such an advantage is relatively difficult to accomplish in the pharmaceutical industry.\u003C\u002Fp>\n",false,{"rendered":510,"protected":508},"\u003Cp>Unveil the transformative journey of a biopharmaceutical firm into the era of Pharma 4.0, achieving a milestone in automation and standardization.”\u003C\u002Fp>\n",1857,"open","standard",{"_acf_changed":508,"content-type":8,"inline_featured_image":508,"footnotes":8},[43],[],[518],137,[520],136,[522,502,523,524,525,526,527,528,529,530],"post-1820","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-studies","cbtw_industries-manufacturing","cbtw_services-smart-industrial-solutions",{"authors":8,"article_authors":508,"direct_external_link":8,"post_region":532,"layout_builder":533},"global",[534],{"acf_fc_layout":535,"title":195,"ui_v2":536,"short_description":537,"cbtw_related_group_filters":538,"items":508,"link":543,"hubspot_form_id":8,"mainPostId":496,"region":532},"block_insights",true,"Access related expert insights",{"cbtw_related_category_filter":539,"cbtw_related_tag_filter":540,"cbtw_related_industry_filter":541,"cbtw_related_service_filter":542},[221,197],[],[],[],{"title":544,"url":545,"target":546},"View all insights","https:\u002F\u002Fstaging.cbtw.tech\u002Finsights","_self","\u003C!-- This site is optimized with the Yoast SEO Premium plugin v25.4 (Yoast SEO v25.4) - https:\u002F\u002Fyoast.com\u002Fwordpress\u002Fplugins\u002Fseo\u002F -->\n\u003Ctitle>Implementing Pharma 4.0 for a Fully Automated Production\u003C\u002Ftitle>\n\u003Cmeta name=\"description\" content=\"Unveil how Pharma 4.0 revolutionizes production with full automation and interconnectivity. 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