{"id":7014,"date":"2023-11-20T11:25:15","date_gmt":"2023-11-20T10:25:15","guid":{"rendered":"https:\/\/tera-environnement.com\/extractibles\/"},"modified":"2024-09-17T12:05:43","modified_gmt":"2024-09-17T10:05:43","slug":"extractables","status":"publish","type":"page","link":"https:\/\/tera-environnement.com\/en\/contamination-control\/extractables\/","title":{"rendered":"Extractables"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"7014\" class=\"elementor elementor-7014 elementor-2041\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5b9e5aa elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5b9e5aa\" data-element_type=\"section\" data-e-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-54448f63\" data-id=\"54448f63\" data-element_type=\"column\" data-e-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-1654c5e5 elementor-widget elementor-widget-shortcode\" data-id=\"1654c5e5\" data-element_type=\"widget\" data-e-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\"><ul id=\"breadcrumbs\"><li><a href=\"https:\/\/tera-environnement.com\/en\/\">Home<\/a><\/li><\/ul><\/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-7e905690 elementor-widget__width-auto elementor-widget elementor-widget-image\" data-id=\"7e905690\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"68\" height=\"69\" src=\"https:\/\/tera-environnement.com\/wp-content\/uploads\/2023\/09\/fleche-grise.png\" class=\"attachment-large size-large wp-image-389\" alt=\"\" \/>\t\t\t\t\t\t\t\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-315aa5c3 elementor-widget__width-auto elementor-widget elementor-widget-heading\" data-id=\"315aa5c3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.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\">Extractables<\/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<div class=\"elementor-element elementor-element-fd6e463 e-flex e-con-boxed e-con e-parent\" data-id=\"fd6e463\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-193726e elementor-widget elementor-widget-spacer\" data-id=\"193726e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a7c23a9 e-flex e-con-boxed e-con e-parent\" data-id=\"a7c23a9\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-120b7e7 e-con-full e-flex e-con e-child\" data-id=\"120b7e7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-be58f65 e-con-full e-flex e-con e-child\" data-id=\"be58f65\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ef1a9e5 elementor-widget elementor-widget-image\" data-id=\"ef1a9e5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"512\" height=\"320\" src=\"https:\/\/tera-environnement.com\/wp-content\/uploads\/2024\/01\/extractibles.jpg\" class=\"attachment-medium_large size-medium_large wp-image-2520\" alt=\"\" srcset=\"https:\/\/tera-environnement.com\/wp-content\/uploads\/2024\/01\/extractibles.jpg 512w, https:\/\/tera-environnement.com\/wp-content\/uploads\/2024\/01\/extractibles-300x188.jpg 300w\" sizes=\"(max-width: 512px) 100vw, 512px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-42ff727 e-con-full e-flex e-con e-child\" data-id=\"42ff727\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2e99aad elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"2e99aad\" data-element_type=\"widget\" data-e-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\">Why characterize extractables and leachables?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-389f9d5 elementor-widget elementor-widget-text-editor\" data-id=\"389f9d5\" data-element_type=\"widget\" data-e-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>Extractables are defined as compounds that can be extracted from packaging materials or devices under controlled experimental conditions. Leachables, a subset of extractables, are compounds that actually migrate into the final product during the expected shelf life or contact time. <\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-709ba8c e-con-full e-flex e-con e-child\" data-id=\"709ba8c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9396b43 elementor-widget elementor-widget-spacer\" data-id=\"9396b43\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\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-6e6f4bb elementor-widget elementor-widget-text-editor\" data-id=\"6e6f4bb\" data-element_type=\"widget\" data-e-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 characterization of extractables and leachables has become increasingly important due to growing global regulations. Because of their potential impact on patient health, many professional sectors are confronted with the problem of extractables and leachables, including the biopharmaceutical sector. <\/p>\n<p>The implementation of extractable and leachable substance tests from the design stage through to the marketing of containers is therefore an essential prerequisite. These tests demonstrate that the concentration of contaminants does not exceed acceptable or regulatory thresholds. <\/p>\n<p>The extractables and leachables that can potentially migrate to the contents obviously depend on the raw materials and manufacturing processes involved in the design of each container, and may be organic or inorganic species.<\/p>\n<p>The diversity of extractables and leachables that can be investigated implies the use of high-performance analytical equipment to perform the various relevant analyses.<\/p>\n<p>The guidelines available for extractables and leachables are specific to each manufacturer&#8217;s sector of activity, but include ICH Q3D, USP 233 (US Pharmacopoeia no. 233: Elemental Impurities &#8211; Procedures) and BPOG.<\/p>\n<p>USP 233 and ICH Q3D are guidelines for the analysis of elemental impurities in pharmaceutical products.<\/p>\n<p>USP 233 describes specific, quantitative analytical procedures for each elemental (inorganic) impurity in pharmaceutical products and ingredients. The USP chapter recommends the use of instrumental techniques such as inductively coupled plasma optical emission spectroscopy (ICP-OES) or ICP-mass spectrometry (ICP-MS). USP also recommends the use of closed containers for digestion of solid samples to ensure quantitative recovery of all regulated analytes, including volatile elements such as mercury.  <\/p>\n<p>ICH Q3D establishes the methodology for the assessment of elemental impurities in pharmaceutical products, including medicinal products for human use. In particular, ICH Q3D recommends an assessment of the risk associated with the presence of elemental impurities in health products. This can be done by means of qualitative or quantitative screening.  <\/p>\n<p>The BPOG standard is a set of best practices for the production of biopharmaceutical drugs. It was developed by the Biophorum Operations Group (BPOG), an international organization of biopharmaceutical industry experts. The BPOG guidelines provide recommendations for the manufacture of biopharmaceutical products, including monoclonal antibodies, vaccines and gene therapies.  <\/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-efe2df3 elementor-widget elementor-widget-spacer\" data-id=\"efe2df3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\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-89bb020 elementor-widget elementor-widget-heading\" data-id=\"89bb020\" data-element_type=\"widget\" data-e-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\">Why choose TERA Environnement to characterize your extractables and leachables? <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5c73626 elementor-widget elementor-widget-spacer\" data-id=\"5c73626\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\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-495ee9e elementor-widget elementor-widget-spacer\" data-id=\"495ee9e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\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-85aaff3 elementor-widget elementor-widget-text-editor\" data-id=\"85aaff3\" data-element_type=\"widget\" data-e-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 aria-level=\"1\"><b>Find out why you should choose our laboratory to help you characterize extractables and leachables:<\/b>\n<ul>\n<li aria-level=\"1\">High-performance analytical equipment for your analyses<\/li>\n<\/ul>\n<ul>\n<li aria-level=\"1\">Wide range of compounds that can be analyzed<\/li>\n<\/ul>\n<ul>\n<li aria-level=\"1\">Very low analytical thresholds or limits of quantification (LOQ) ranging from ppt to ppb, enabling compliance with regulations<\/li>\n<\/ul>\n<ul>\n<li aria-level=\"1\">Flexibility and responsiveness<\/li>\n<\/ul>\n<ul>\n<li aria-level=\"1\">Customized study of your specifications to offer you all the analyses you need to study your extractables and leachables<\/li>\n<\/ul>\n<ul>\n<li aria-level=\"1\"> Experience in managing project to various standards: BPOG, USP 233 and ICH Q3D etc.<\/li>\n<\/ul>\n<\/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-43cac89 elementor-widget elementor-widget-spacer\" data-id=\"43cac89\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\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-401fe74 elementor-widget elementor-widget-heading\" data-id=\"401fe74\" data-element_type=\"widget\" data-e-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\">What technical resources do we have to characterize extractables and leachables?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-0e88e43 e-con-full e-flex e-con e-child\" data-id=\"0e88e43\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ba78eb4 elementor-widget elementor-widget-image\" data-id=\"ba78eb4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"466\" height=\"466\" src=\"https:\/\/tera-environnement.com\/wp-content\/uploads\/2024\/01\/armoire.jpg\" class=\"attachment-large size-large wp-image-2529\" alt=\"\" srcset=\"https:\/\/tera-environnement.com\/wp-content\/uploads\/2024\/01\/armoire.jpg 466w, https:\/\/tera-environnement.com\/wp-content\/uploads\/2024\/01\/armoire-300x300.jpg 300w, https:\/\/tera-environnement.com\/wp-content\/uploads\/2024\/01\/armoire-150x150.jpg 150w, https:\/\/tera-environnement.com\/wp-content\/uploads\/2024\/01\/armoire-100x100.jpg 100w\" sizes=\"(max-width: 466px) 100vw, 466px\" \/>\t\t\t\t\t\t\t\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-a0c7aac elementor-widget elementor-widget-text-editor\" data-id=\"a0c7aac\" data-element_type=\"widget\" data-e-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 aria-level=\"1\"><b>Enclosures for prolonged extraction of your containers before analysis of extractables or leachables <\/b><\/li>\n<\/ul>\n<p>TERA Environnement has a range of enclosures, with or without agitation, and with temperature control up to 100\u00b0C.<\/p>\n<p>Containers can be extracted with various organic or inorganic solvents, medicinal solutions, etc.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ff15347 elementor-widget elementor-widget-text-editor\" data-id=\"ff15347\" data-element_type=\"widget\" data-e-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 aria-level=\"1\"><b>Preparation of extracts before analysis of extractables or leachables <\/b><\/li>\n<\/ul>\n<p>Pre-concentration steps such as liquid extractions, acidifications and dilutions, as well as microwave mineralization techniques, may be required before extractables analysis.<b><\/b><\/p>\n<ul>\n<li aria-level=\"1\"><b>High-performance analytical equipment <\/b><\/li>\n<\/ul>\n<p>TERA Environnement has a range of analytical equipment to help you find inorganic and organic extractables and leachables. <\/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-ad2c84c elementor-widget elementor-widget-accordion\" data-id=\"ad2c84c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1811\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"button\" aria-controls=\"elementor-tab-content-1811\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Inductively coupled plasma mass or optical emission spectrometry (ICP-MS or ICP-OES) for metals <\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1811\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"region\" aria-labelledby=\"elementor-tab-title-1811\"><ul>\n<li>Aluminium (Al); Antimony (Sb); Silver (Ag); Arsenic (As); Barium (Ba); Bismuth (Bi); Boron (B); Cadmium (Cd); Calcium (Ca); Chromium (Cr); Cobalt (Co); Copper (Cu); Tin (Sn); Iron (Fe); Germanium (Ge); Iridium (Ir); Lithium (Li); Magnesium (Mg); Manganese (Mn); Mercury (Hg); Molybdenum (Mo); Nickel (Ni); Gold (Au); Osmium (Os); Palladium (Pd); Platinum (Pt); Lead (Pb); Potassium (K); Rhodium (Rh); Ruthenium (Ru); Selenium (Se); Silicon (Si); Sodium (Na); Strontium (Sr); Thallium (Tl); Titanium (Ti); Tungsten (W); Vanadium (V); Zinc (Zn); Zirconium (Zr) <\/li>\n<\/ul>\n<p><i>Non-exhaustive list<\/i><\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1812\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"button\" aria-controls=\"elementor-tab-content-1812\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Ion chromatography (IC) for anions<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1812\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"region\" aria-labelledby=\"elementor-tab-title-1812\"><ul>\n<li>Formate; Acetate; Propionate; Acrylate; Lactate; Butyrate; Isobutyrate; Maleate; Valerate; Isovalerate; Caproate<\/li>\n<\/ul>\n<p><i>Non-exhaustive list <\/i><\/p>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-1813\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"button\" aria-controls=\"elementor-tab-content-1813\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-left\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" tabindex=\"0\">Gas chromatography-mass spectrometry (GC MS)<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-1813\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" 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Extractables are defined as compounds that can be extracted from packaging materials or devices under controlled experimental conditions. Leachables, a subset of extractables, are compounds that actually migrate into the final product during the expected shelf life or contact time. The characterization of extractables and leachables has become increasingly important [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":7043,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-7014","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Analysis of extractables and leachables<\/title>\n<meta name=\"description\" content=\"Extractables and leachables tests to demonstrate that contaminant concentrations do not exceed regulatory thresholds.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/tera-environnement.com\/en\/contamination-control\/extractables\/\" \/>\n<meta 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