{"id":10316,"date":"2021-09-20T10:48:04","date_gmt":"2021-09-20T08:48:04","guid":{"rendered":"https:\/\/www.s4bt.it\/convalida-delle-utilities-di-stabilimento\/"},"modified":"2026-02-02T09:12:22","modified_gmt":"2026-02-02T08:12:22","slug":"validation-of-facility-utilities","status":"publish","type":"page","link":"https:\/\/www.s4bt.it\/en\/projects\/validation-of-facility-utilities\/","title":{"rendered":"Validation of Facility Utilities"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"10316\" class=\"elementor elementor-10316 elementor-2526\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5caa6a60 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5caa6a60\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-extended\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-79c31706\" data-id=\"79c31706\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-78b42e45 elementor-widget elementor-widget-heading\" data-id=\"78b42e45\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\">PROJECTS<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3047bad6 elementor-widget-divider--separator-type-pattern elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"3047bad6\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\" style=\"--divider-pattern-url: url(&quot;data:image\/svg+xml,%3Csvg xmlns=&#039;http:\/\/www.w3.org\/2000\/svg&#039; preserveAspectRatio=&#039;none&#039; overflow=&#039;visible&#039; height=&#039;100%&#039; viewBox=&#039;0 0 20 16&#039; fill=&#039;none&#039; stroke=&#039;black&#039; stroke-width=&#039;1&#039; stroke-linecap=&#039;square&#039; stroke-miterlimit=&#039;10&#039;%3E%3Cg transform=&#039;translate(-12.000000, 0)&#039;%3E%3Cpath d=&#039;M28,0L10,18&#039;\/%3E%3Cpath d=&#039;M18,0L0,18&#039;\/%3E%3Cpath d=&#039;M48,0L30,18&#039;\/%3E%3Cpath d=&#039;M38,0L20,18&#039;\/%3E%3C\/g%3E%3C\/svg%3E&quot;);\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7baa2b59 elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"7baa2b59\" data-element_type=\"widget\" data-widget_type=\"theme-post-title.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Validation of Facility Utilities<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-18e20fcb elementor-widget elementor-widget-text-editor\" data-id=\"18e20fcb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Client: <\/strong><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\">a company that has always been involved in the research, development and marketing of innovative medicines.<\/span><\/p>\n<p><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\"><strong>Sector:<\/strong> Pharmaceuticals<\/span><\/p>\n<p><strong>Objective:<\/strong> to validate a number elements affecting the systems, specifically the points<br \/>of use (end point of a distribution network) of utilities serving production, i.e. water, gaseous\/liquid nitrogen and compressed air<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4a431c26 elementor-widget elementor-widget-heading\" data-id=\"4a431c26\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Project<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-39c122e9 elementor-widget elementor-widget-text-editor\" data-id=\"39c122e9\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\">The client company is a leading international chemical-pharmaceutical producer, engaged for decades in the development of new medicines, the introduction of cutting-edge technologies and innovative health management practices. <\/span><\/p>\n<p><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\">The client needed to validate certain elements affecting the plants, specifically the points of use (end point of a distribution network) of the utilities serving production, namely water, gaseous\/liquid nitrogen and compressed air.<\/span><\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3799783b elementor-widget elementor-widget-heading\" data-id=\"3799783b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Our contribution<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-76ab4c73 elementor-widget elementor-widget-text-editor\" data-id=\"76ab4c73\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul>\n<li>The validation of the utilities was carried out through the drafting and execution of appropriate performance qualification protocols involving chemical and\/or microbiological analysis of the most critical points of use.<\/li>\n<\/ul>\n<p>This criticality was supported by a preliminary risk analysis process in accordance with directive <b>ICH Q9 Quality Risk Management<\/b> &#8211; November 2005.<\/p>\n<p>The choice of points to be monitored (whether new or existing) was then justified and based on the analytical results it was possible to predict a <b>periodic monitoring plan<\/b> guaranteeing the quality of the points of use in accordance with current regulations and the customer&#8217;s internal specifications. <\/p>\n<p>This activity required a considerable commitment and specific <b>expertise<\/b> from a<br \/> <b>technical<\/b>, <b>documentary<\/b>, and <b>regulatory<\/b>point of view. For this reason, the client turned to an external service provider.<\/p>\n<p>On the basis of the reference legislation (Official Pharmacopoeia, GxP, Edralex) and internal procedures, the work team analysed the requirements envisaged by the project and prepared a <b>Risk Analysis<\/b> document in accordance with the <b>FMEA<\/b> methodology to establish points-of-use criticality. <\/p>\n<p>Once the points of use with a medium\/high criticality level (i.e. with a significant risk of contamination of the product or materials) were identified, it was possible to choose which ones to sample and therefore which ones to submit to the <b>chemical\/microbiological analyses<\/b> provided for in the validation protocol.<\/p>\n<p>At the end of the qualification phase for the points of use, a Periodic <b>Monitoring Plan<\/b> was developed, in which, through a further Risk Analysis process, the points of use to be included in the routine sampling (periodic analyses) were defined. <\/p>\n<p><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\">The project included the installation of both new points of use and modifications <\/span>to existing points of use; the planned activities originated from several existing projects including: <span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size );\"><b>construction of a new laboratory<\/b><\/span><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\">, <\/span><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size );\"><b>construction of a new granulation area<\/b><\/span><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\">, and <\/span><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size );\"><b>revamping<\/b><\/span><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\"> of pre-existing areas. <\/span> <\/p>\n<p>The complexity of projects related to utility validation activities has required several <span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\">months of work and continuous collaboration with the various departments of the client company, including the <\/span><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size );\"><b>Quality,<\/b><\/span><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\"> the <\/span><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size );\"><b>Validation<\/b><\/span><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\">, the <\/span><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size );\"><b>Production and<\/b><\/span><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\">, <\/span><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size );\"><b>the Engineering departments<\/b><\/span><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\"> and the <\/span><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size );\"><b>chemical and microbiological<\/b><\/span><span style=\"color: var( --e-global-color-text ); font-size: var( --e-global-typography-primary-font-size ); font-weight: var( --e-global-typography-primary-font-weight );\"> Laboratories; <\/span>the need to interface with the company&#8217;s different operational areas has highlighted S4BT&#8217;s ability to adapt to any context and to establish fruitful cooperation with all work teams<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2a4d3524 elementor-widget elementor-widget-heading\" data-id=\"2a4d3524\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Result<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1236adf6 elementor-widget elementor-widget-text-editor\" data-id=\"1236adf6\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The project contributed to the implementation of a <b>Risk Analysis<\/b> process which had not been in place until then. <\/p>\n<p>Furthermore, the analysis served as the initial basis of a <b>process<\/b> aimed at eliminating the numerous microbiological and chemical samplings required from the respective laboratories. <\/p>\n<p>The completed work laid the foundations for a <b>controlled management of sampling plans<\/b> and analysis in accordance with the current QRM.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-2052c391 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2052c391\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-51bb928d\" data-id=\"51bb928d\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-87449ce elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"87449ce\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">read about other projects<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-11939b6e elementor-widget elementor-widget-text-editor\" data-id=\"11939b6e\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li><a href=\"https:\/\/www.s4bt.it\/en\/projects\/assessment-csv\/\">Assessment of the control system for filling\/packaging machines<\/a><\/li><li><a href=\"https:\/\/www.s4bt.it\/en\/projects\/packaging-strategy\/\">Packaging Strategy<\/a><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20b7ee85 elementor-absolute elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"20b7ee85\" data-element_type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-21ebdc8b\" data-id=\"21ebdc8b\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7e0007d elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"7e0007d\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-7b6e526c\" data-id=\"7b6e526c\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:10346,&quot;url&quot;:&quot;https:\\\/\\\/www.s4bt.it\\\/wp-content\\\/uploads\\\/2021\\\/06\\\/pharmaceutical-industry-1-2.jpg&quot;}],&quot;background_slideshow_loop&quot;:&quot;yes&quot;,&quot;background_slideshow_slide_duration&quot;:5000,&quot;background_slideshow_slide_transition&quot;:&quot;fade&quot;,&quot;background_slideshow_transition_duration&quot;:500}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-73a590d8 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"73a590d8\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/www.s4bt.it\/\/consulenza-validazione-qualifiche\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">VALIDATION &amp; QUALIFICATION<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-482766c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"482766c\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-28926c3\" data-id=\"28926c3\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-843ed3c elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"843ed3c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">CONSULTANCY SERVICES PURCHASED BY THE CLIENT COMPANY<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b00b603 elementor-widget elementor-widget-text-editor\" data-id=\"b00b603\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li><a href=\"https:\/\/www.s4bt.it\/en\/consulting\/equipment-and-facilities-qualification\/\">Equipment, environment, and utilities qualification<\/a><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6ec494b elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"6ec494b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">REQUEST more information<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2d96dea elementor-widget elementor-widget-shortcode\" data-id=\"2d96dea\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\"><script src=\"https:\/\/a.leadbi.com\/f\/f26e9066-78f4-415e-afbc-63b8e73010b8.js\" id=\"f26e9066-78f4-415e-afbc-63b8e73010b8\" defer><\/script><\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>PROJECTS Client: a company that has always been involved in the research, development and marketing of innovative medicines. Sector: Pharmaceuticals Objective: to validate a number elements affecting the systems, specifically the pointsof use (end point of a distribution network) of utilities serving production, i.e. water, gaseous\/liquid nitrogen and compressed air Project The client company is [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":10646,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-10316","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Validation of Facility Utilities - S4BT<\/title>\n<meta name=\"description\" content=\"Utility validation project carried out by drafting and executing appropriate performance qualification protocols.\" \/>\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.s4bt.it\/en\/projects\/validation-of-facility-utilities\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Validation of Facility Utilities - 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