{"id":10407,"date":"2021-09-22T11:13:41","date_gmt":"2021-09-22T09:13:41","guid":{"rendered":"https:\/\/www.s4bt.it\/validation-of-analytical-methods-for-the-ehs-department\/"},"modified":"2024-04-08T12:30:22","modified_gmt":"2024-04-08T10:30:22","slug":"validation-of-analytical-methods-for-the-ehs-department","status":"publish","type":"page","link":"https:\/\/www.s4bt.it\/en\/projects\/validation-of-analytical-methods-for-the-ehs-department\/","title":{"rendered":"Analytical method validation for the EHS department"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"10407\" class=\"elementor elementor-10407 elementor-2437\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-16bc725a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"16bc725a\" 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-faaf5f7\" data-id=\"faaf5f7\" 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-4e703ddf elementor-widget elementor-widget-heading\" data-id=\"4e703ddf\" 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-361ac9c0 elementor-widget-divider--separator-type-pattern elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"361ac9c0\" 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-77ca4610 elementor-widget elementor-widget-theme-post-title elementor-page-title elementor-widget-heading\" data-id=\"77ca4610\" 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\">Analytical method validation for the EHS department<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6d72f8f2 elementor-widget elementor-widget-text-editor\" data-id=\"6d72f8f2\" 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 drugs.<\/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> Pharmaceutical<\/span><\/p>\n<p><strong>Objective:<\/strong> to develop and validate an HPLC analytical method for the determination of residual solvents in gaseous emissions in non-confined environments.<\/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-a5ab22e elementor-widget elementor-widget-heading\" data-id=\"a5ab22e\" 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-6982f2ec elementor-widget elementor-widget-text-editor\" data-id=\"6982f2ec\" 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 company is  a leading international chemical-pharmaceutical producer, engaged for decades in the development of new drugs, the introduction of cutting-edge technologies and innovative health management practices. <\/p>\n<p>In view of <strong>continual improvement<\/strong> and compliance with sector regulations and internal procedures, the Client saw the need to develop and validate an <strong>HPLC analytical method<\/strong> for the determination of residual solvents in gaseous emissions in non-confined environments.<\/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-1ccf7fc0 elementor-widget elementor-widget-heading\" data-id=\"1ccf7fc0\" 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-37554df7 elementor-widget elementor-widget-text-editor\" data-id=\"37554df7\" 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 S4BT Consultants took care of both the <strong>analytical part<\/strong>, (including the development of the method and the execution of all the analytical tests), and the <strong>documentary part<\/strong>, including the writing of the protocols and the related report.<\/p>\n<p>The following <strong>requirements<\/strong>were verified for the development:<\/p>\n<ul>\n<li>specificity<\/li>\n<li>the capacity of a method to distinguish the analyte it is intended to measure from others<br \/>substances<\/li>\n<li>linearity<\/li>\n<li>the capacity to provide results that are directly proportional to the concentration of<br \/>analytes in samples within a certain validity range<\/li>\n<li>accuracy<\/li>\n<li>analysis of samples with a known concentration that must fall within a certain validity range<\/li>\n<li>quantitation limit<\/li>\n<li>the lowest point at which it is possible to quantify a compound<\/li>\n<li>determination limit<\/li>\n<li>the minimum point at which a compound can be seen but not quantified<\/li>\n<li>resilience<\/li>\n<li>the sensitivity of an analytical method to variations in experimental conditions<\/li>\n<li>replicability<\/li>\n<li>determination of repeatability and instrumental precision<\/li>\n<\/ul>\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-9e4b97b elementor-widget elementor-widget-heading\" data-id=\"9e4b97b\" 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-7d2b0c5e elementor-widget elementor-widget-text-editor\" data-id=\"7d2b0c5e\" 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 analytical method developed and validated has fully satisfied all the parameters established by the client and those required by the reference standards. The method is still used successfully by the pharmaceutical company.<\/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-58692c98 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"58692c98\" 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-78e8c2a7\" data-id=\"78e8c2a7\" 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-330833d4 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"330833d4\" 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-40fc5c6e elementor-widget elementor-widget-text-editor\" data-id=\"40fc5c6e\" 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\/management-of-process-deviation-change-control-capa\/\">Process Deviation Management, Change Control, CAPA<\/a><\/li><li><a href=\"https:\/\/www.s4bt.it\/en\/projects\/issue-of-certificates-of-analysis-in-electronic-format\/\">Issuance of certificates in electronic format<\/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-119995e2 elementor-absolute elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"119995e2\" 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-299e3d6\" data-id=\"299e3d6\" 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-da2ca48 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"da2ca48\" 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\/attivita-di-consulenza-e-validazione\/quality-regulatory-s4bt-consulting\/\">\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\">Quality &amp; regulatory<\/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<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-aa57879 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default\" data-id=\"aa57879\" 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-3649856\" data-id=\"3649856\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:4876,&quot;url&quot;:&quot;https:\\\/\\\/www.s4bt.it\\\/wp-content\\\/uploads\\\/2021\\\/06\\\/almighty-pill.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\">\n\t\t\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-2aceed8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2aceed8\" 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-cf9da07\" data-id=\"cf9da07\" 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-9f530ad elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"9f530ad\" 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 SERVICES 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-1f24d4e elementor-widget elementor-widget-text-editor\" data-id=\"1f24d4e\" 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><a href=\"https:\/\/www.s4bt.it\/\/quality-regulatory-s4bt-consulting\/\">Quality Control<\/a><\/li>\n<\/ul>\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-bb80e07 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"bb80e07\" 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-64b663b elementor-widget elementor-widget-html\" data-id=\"64b663b\" 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 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>\n      <label for=\"field[25]\" class=\"_form-label\">\n        How can we help?*\n      <\/label>\n      <div class=\"_field-wrapper\">\n        <select name=\"field[25]\" id=\"field[25]\" required>\n          <option selected>\n          <\/option>\n          <option value=\"Validation and Qualification Consulting\" >\n            Validation and Qualification Consulting\n          <\/option>\n          <option value=\"Project Management\" >\n            Project Management\n          <\/option>\n          <option value=\"Quality and Regulatory\" >\n            Quality and Regulatory\n          <\/option>\n          <option value=\"Other information\" >\n            Other information\n          <\/option>\n        <\/select>\n      <\/div>\n    <\/div>\n    <div class=\"_form_element _x10568941 _full_width \" >\n      <label for=\"field[6]\" class=\"_form-label\">\n        Message*\n      <\/label>\n      <div class=\"_field-wrapper\">\n        <textarea id=\"field[6]\" name=\"field[6]\" placeholder=\"Please leave us a message\"  required><\/textarea>\n      <\/div>\n    <\/div>\n    <div class=\"_form_element _x49521979 _full_width \" >\n      <fieldset class=\"_form-fieldset\">\n        <div class=\"_row\">\n          <legend 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 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