{"id":10422,"date":"2021-09-22T11:14:23","date_gmt":"2021-09-22T09:14:23","guid":{"rendered":"https:\/\/www.s4bt.it\/revamping-coating-and-blister-area\/"},"modified":"2026-02-02T09:13:42","modified_gmt":"2026-02-02T08:13:42","slug":"revamping-coating-and-blister-area","status":"publish","type":"page","link":"https:\/\/www.s4bt.it\/en\/projects\/revamping-coating-and-blister-area\/","title":{"rendered":"Revamping of the Coating and Blister Area"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"10422\" class=\"elementor elementor-10422 elementor-5666\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-05c342b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"05c342b\" data-element_type=\"section\">\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-top-column elementor-element elementor-element-8eff496\" data-id=\"8eff496\" 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-45ec5aae elementor-widget elementor-widget-heading\" data-id=\"45ec5aae\" 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-ffdbb4e elementor-widget-divider--separator-type-pattern elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"ffdbb4e\" 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-9dc994b elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"9dc994b\" 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\">Revamping of the Coating and Blister Area<\/h1>\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-top-section elementor-element elementor-element-6d66befc elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6d66befc\" 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-6e7837f6\" data-id=\"6e7837f6\" 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-54b30af8 elementor-widget elementor-widget-text-editor\" data-id=\"54b30af8\" 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>The company is a leading international chemical-pharmaceutical company, engaged for decades in the development of new drugs, the introduction of cutting-edge technologies and innovative health management practices.<\/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> chemical-pharmaceutical<\/span><\/p>\n<p><strong>Objective:<\/strong> to align the Coating and Blister area with the new standards already present in other areas of the facility and to implement some changes that are part of a broader, well-structured project.<\/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-5f1aa685 elementor-widget elementor-widget-heading\" data-id=\"5f1aa685\" 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-17064144 elementor-widget elementor-widget-text-editor\" data-id=\"17064144\" 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>Revamping of an area in a pharmaceutical company does not end with the mere physical relocation of the systems, but entails the involvement of numerous resources and a series of more demanding measures covering the entire area involved, mechanical\/electrical parts, documentation and management applications.<\/p>\n<p>The activities required by a revamping project therefore include a series of actions and checks aimed at testing correct operation after the changes, in compliance with current regulations (GMP and safety regulations).<\/p>\n<p>The release of each area also depends on the successful outcome of all the activities envisaged and planned by the project and on authorisation by AIFA (Italian Drug Agency) For the activities envisaged by the Coating and Blister Area revamping projects, the Client wanted to rely on an external partner, with solid experience in the sector.<\/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-43c0ab78 elementor-widget elementor-widget-heading\" data-id=\"43c0ab78\" 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-57587718 elementor-widget elementor-widget-text-editor\" data-id=\"57587718\" 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 Client requested the specific technical skills of the S4BT equipment, systems and utilities qualification team.<\/p>\n<p>After a careful analysis and selection of possible partners, the client company chose S4BT, finding within it the essential professionalism and skills to achieve the established objective. The S4BT work team performed the following activities for the revamping of the Coating area:<\/p>\n<ul>\n<li>Drafting of the validation documentation (FRS\/FS; IOQ, Validation report and traceability matrix)<\/li>\n<li>IOQ (drafting, compilation, test execution and final data collection) following the installation of tanks equipped with agitators, commissioning of portable tanks for the transfer of Coating to the drum mixer area and commissioning of tanks with micronisers.<\/li>\n<\/ul>\n<p>The team was also directly involved in adapting the operation of the SCADA supervision and control system in the HVAC system to the regulations, with particular attention to alarms, interlocks, I\/O signals, the graphic interface, hardware and software configurations, IP addresses, field communication protocols and field devices.<\/p>\n<p>For the revamping of the Blister area, the S4BT Team worked on:<\/p>\n<ul>\n<li>Drafting of validation documentation and test execution<\/li>\n<li>Replacement and validation of a PLC in consideration of new I\/O signals, alarms and relevant trends of the Pharma department HVAC systems<\/li>\n<li>Proper reactivation of the blister lines following a relocation, with particular attention to correct installation<\/li>\n<li>Functional revalidation of the dedicated HVACs in each blister sector and the HVAC installed in the secondary packaging area. The validation took into account the graphic synoptics, alarms and trends.<\/li>\n<li>Revalidation of the Data Matrix code (serialised two-dimensional barcodes on boxes) management software installed on the packaging lines to ensure product traceability.<\/li>\n<li>Revalidation of the Arlequin vision software system installed on the packaging lines, in order to ensure the main software functions and their integration with the packaging line following the changes. <\/li>\n<\/ul>\n<p>This validation included general checks on the functioning of the machinery within the process (management of waste from non-compliant products and packaging, camera settings and functional check on PVC plates).<\/p>\n<p>The S4BT consultants cooperated in synergy with various areas of the Client company, including Quality, Validation, Production and Engineering, for the entire duration of the project. <\/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-1d91d91 elementor-widget elementor-widget-heading\" data-id=\"1d91d91\" 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-c1fc7e9 elementor-widget elementor-widget-text-editor\" data-id=\"c1fc7e9\" 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>An ad hoc validation approach was proposed and implemented for the blister line revamping project, which involved numerous different IT systems.<\/p>\n<p>The S4BT team fulfilled the client&#8217;s needs with a &#8220;custom&#8221; solution, tailored to the specific needs and particular features of the client company.<\/p>\n<p>As part of the same project, with S4BT&#8217;s intervention, the Client also obtained validation of the computerised and process systems for the final release in the production environment, thereby<br \/>saving time and achieving compliance with the mandatory requirements of the regulatory bodies.<\/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-65372b0e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"65372b0e\" 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-5566ed5a\" data-id=\"5566ed5a\" 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-29151294 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"29151294\" 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-5599c317 elementor-widget elementor-widget-text-editor\" data-id=\"5599c317\" 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\/validation-of-facility-utilities\/\">Validation of Facility Utilities<\/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-2b6a6feb elementor-absolute elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"2b6a6feb\" 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-56fddb3c\" data-id=\"56fddb3c\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&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<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-12fb7de elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"12fb7de\" 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-63832417\" data-id=\"63832417\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:10397,&quot;url&quot;:&quot;https:\\\/\\\/www.s4bt.it\\\/wp-content\\\/uploads\\\/2021\\\/06\\\/process-cleaning-Packaging-validation.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-a5b48b7 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"a5b48b7\" 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\/\/pragma-wfm\/\">\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-6aa0b02 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6aa0b02\" 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-f8e373f\" data-id=\"f8e373f\" 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-2dca097 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"2dca097\" 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\">CONSULTING SERVICE ACQUIRED 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-2567c7e elementor-widget elementor-widget-text-editor\" data-id=\"2567c7e\" 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-37d2967 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"37d2967\" 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-d528954 elementor-widget elementor-widget-html\" data-id=\"d528954\" data-element_type=\"widget\" data-widget_type=\"html.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<style>@import url(https:\/\/fonts.bunny.net\/css?family=poppins:400,700);<\/style>\n<style>\n#_form_46_{font-size:14px;line-height:1.6;font-family:arial, helvetica, sans-serif;margin:0}#_form_46_ 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for=\"field[22][]\" class=\"_form-label\">\n          <\/legend>\n        <\/div>\n        <input data-autofill=\"false\" type=\"hidden\" id=\"field[22][]\" name=\"field[22][]\" value=\"~|\">\n        <div class=\"_row _checkbox-radio\">\n          <input id=\"field_22I have read the Privacy Statement and I authorize the treatment of my personal data (GDPR May 25, 2018)\" type=\"checkbox\" name=\"field[22][]\" value=\"I have read the Privacy Statement and I authorize the treatment of my personal data (GDPR May 25, 2018)\"   required>\n          <span>\n            <label for=\"field_22I have read the Privacy Statement and I authorize the treatment of my personal data (GDPR May 25, 2018)\">\n              I have read the Privacy Statement and I authorize the treatment of my personal data (GDPR May 25, 2018)*\n            <\/label>\n          <\/span>\n        <\/div>\n      <\/fieldset>\n    <\/div>\n    <div class=\"_form_element _x07624565 _full_width _clear\" >\n      <div 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