{"id":202991,"date":"2025-08-12T11:12:01","date_gmt":"2025-08-12T10:12:01","guid":{"rendered":"https:\/\/www.merieuxnutrisciences.com\/?page_id=202991"},"modified":"2025-08-19T09:47:15","modified_gmt":"2025-08-19T08:47:15","slug":"tests-stabilite-pharma-stockage-echantillons","status":"publish","type":"page","link":"https:\/\/www.merieuxnutrisciences.com\/fr\/pharma\/tests-stabilite-pharma-stockage-echantillons\/","title":{"rendered":"Tests de stabilit\u00e9 et Stockage des \u00e9chantillons pharmaceutiques"},"content":{"rendered":"\n<div class=\"page-header-block-wrapper fullwidth-block\">\n    <div class=\"acf-page-header\" style=\"background-image: url('https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/shutterstock_90590236_mod-scaled.jpg'); \">\n        <div class=\"overlay\"><\/div>\n        <div class=\"acf-page-header-container\">\n                            <div class=\"image-wrapper\">\n                    <img decoding=\"async\" src=\"https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2024\/08\/Test-di-stabilita-e-stoccaggio-campioni-bianco.png\" alt=\"Icon\" \/>\n                <\/div>\n                        <h1>Tests de stabilit\u00e9 et Stockage des \u00e9chantillons pharmaceutiques<\/h1>\n        <\/div>\n    <\/div>\n<\/div>\n\n<style>\n.page-header-block-wrapper{\n    margin-bottom: 60px;\n}\n\n.fullwidth-block {\n    max-width: none !important;\n    width: 100vw !important;\n    position: relative;\n    padding:0px;\n    left: 50%;\n    right: 50%;\n    margin-left: -50vw;\n    margin-right: -50vw;\n}\n\n.acf-page-header {\n    background-size: cover;\n    background-position: center;\n    display: flex;\n    position: relative;\n    min-height: 250px; \n}\n\n.acf-page-header-container{\n    margin: 0 auto;\n    padding: 48px 24px;\n    display: flex;\n    flex-direction: column;\n    justify-content: end;\n    align-items: center;\n}\n\n.acf-page-header .overlay {\n    position: absolute;\n    top: 0;\n    left: 0;\n    right: 0;\n    bottom: 0;\n    background: linear-gradient(to top, var(--global-palette4), transparent);\n    z-index: 1;\n}\n\n.acf-page-header-container .image-wrapper{\n    position:relative;\n    height: 70px;\n    width: 70px;\n    background: var(--global-palette4);\n    border-radius: 50%;\n    z-index: 1;\n}\n\n.acf-page-header-container img{\n    position: absolute;\n    top: 50%;\n    left: 50%;\n    transform: translate(-50%, -50%);\n    max-width:40px;\n    z-index: 2;\n}\n\n.acf-page-header h1 {\n    display:block;\n    position: relative;\n    z-index: 2;\n    color:white;\n    text-align: center;\n}\n\n@media (min-width: 1025px) {\n    .acf-page-header-container{\n        width: 1290px;\n    }\n    \n}\n\n@media (max-width: 1024px) {\n    .acf-page-header-container {\n        align-self: end;\n    }\n    .acf-page-header .overlay {\n        background: linear-gradient(to top, var(--global-palette4), transparent);\n    }\n}\n\n@media (max-width: 768px) {\n    .acf-page-header .overlay {\n        background: linear-gradient(to top, var(--global-palette4), transparent);\n    }\n    .acf-page-header h1 {\n        font-size:28px;\n    }\n}\n\n<\/style>\n\n\n\n\n<p class=\"wp-block-paragraph\">Des \u00e9tudes formelles de stabilit\u00e9 (en cours, \u00e0 long terme, acc\u00e9l\u00e9r\u00e9es et interm\u00e9diaires) sont <strong>r\u00e9alis\u00e9es sur des lots primaires et\/ou de production conform\u00e9ment \u00e0 un protocole de stabilit\u00e9 prescrit pour \u00e9tablir ou confirmer la p\u00e9riode de r\u00e9\u00e9valuation d&rsquo;un API ou la dur\u00e9e de conservation d&rsquo;un produit fini<\/strong>.<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<hr>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Notre Laboratoire d\u00e9di\u00e9 aux \u00e9tudes de stabilit\u00e9 pharmaceutiques et au stockage des \u00e9chantillons<\/h2>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-the-climate-chambers\">Les chambres climatiques<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\" style=\"font-size:18px\">Notre laboratoire est \u00e9quip\u00e9 de chambres de stabilit\u00e9 avanc\u00e9es con\u00e7ues pour r\u00e9pondre aux exigences rigoureuses des tests de stabilit\u00e9 pharmaceutique. Chaque chambre est soigneusement surveill\u00e9e et contr\u00f4l\u00e9e pour garantir des conditions environnementales pr\u00e9cises.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-the-capabilities\">Capacit\u00e9s<\/h3>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">Le stockage est conforme aux directives ICH. En effet, nos chambres de stabilit\u00e9 r\u00e9pondent \u00e0 ces exigences et offrent des conditions de stockage fiables et pr\u00e9cises pour les produits pharmaceutiques. Sont disponibles, entre autres, les param\u00e8tres de stockage suivants :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Chambres de 58 m\u00b3 (2 unit\u00e9s, <strong>sans r\u00e9servation<\/strong>)<\/strong> : grandes chambres pouvant accueillir de grands volumes d&rsquo;\u00e9chantillons.<\/li>\n\n\n\n<li><strong>Chambres de 44 m\u00b3 (2 unit\u00e9s, <strong>sans r\u00e9servation<\/strong>)<\/strong> : comprend une pi\u00e8ce sp\u00e9cifiquement \u00e9quip\u00e9e pour les conditions de faible humidit\u00e9.<\/li>\n\n\n\n<li><strong>Chambres de 22 m\u00b3 (7 unit\u00e9s, <strong>sans r\u00e9servation<\/strong>)<\/strong>&nbsp;: plusieurs chambres pour r\u00e9pondre \u00e0 diff\u00e9rents besoins de tests de stabilit\u00e9.<\/li>\n\n\n\n<li><strong>Armoires de 1,5 m\u00b3 (5 unit\u00e9s)<\/strong> : conditions personnalis\u00e9es.<\/li>\n\n\n\n<li><strong>Chambres de photostabilit\u00e9<\/strong> : conformes \u00e0 la norme ICH Q1B Option 1 et 2 pour \u00e9valuer les effets de l&rsquo;exposition \u00e0 la lumi\u00e8re.<\/li>\n\n\n\n<li><strong>Armoires de diff\u00e9rentes tailles<\/strong> : solutions de stockage personnalisables pour r\u00e9pondre aux besoins sp\u00e9cifiques des clients, couvrant toute la gamme des conditions climatiques ICH.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-the-team\">L&rsquo;\u00e9quipe<\/h3>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Notre \u00e9quipe de scientifiques et de techniciens poss\u00e8de une <strong>vaste exp\u00e9rience dans les tests de stabilit\u00e9 pharmaceutique<\/strong>, garantissant que tous les tests sont effectu\u00e9s avec pr\u00e9cision et efficacit\u00e9.<\/li>\n\n\n\n<li>Nous maintenons<strong> des normes de contr\u00f4le de qualit\u00e9 \u00e9lev\u00e9es<\/strong>, en adh\u00e9rant aux directives r\u00e9glementaires et en employant des protocoles de test rigoureux pour garantir des r\u00e9sultats fiables.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-additional-features\">Fonctionnalit\u00e9s suppl\u00e9mentaires :<\/h3>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Chaque chambre de stabilit\u00e9 est \u00e9quip\u00e9e de syst\u00e8mes de contr\u00f4le climatique <\/strong>sophistiqu\u00e9s pour maintenir des niveaux de temp\u00e9rature et d&rsquo;humidit\u00e9 constants, garantissant ainsi l&rsquo;int\u00e9grit\u00e9 des \u00e9chantillons conserv\u00e9s.<\/li>\n\n\n\n<li>Les syst\u00e8mes de <strong>surveillance continue<\/strong> fournissent des donn\u00e9es et des alertes en temps r\u00e9el. Un <strong>rapport complet est fourni<\/strong> pour garantir la transparence et la tra\u00e7abilit\u00e9.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Nos chambres de stabilit\u00e9 sont con\u00e7ues pour prendre en charge une large gamme de produits pharmaceutiques, garantissant leur s\u00e9curit\u00e9 et leur efficacit\u00e9 tout au long de leur cycle de vie. Que vous ayez besoin de conditions ICH standard ou de solutions de stockage personnalis\u00e9es, nos installations sont \u00e9quip\u00e9es pour r\u00e9pondre \u00e0 vos besoins.<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<hr>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\">Nos services &#8211; Tests de Stabilit\u00e9 et stockage des \u00e9chantillons<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Les <strong>conditions de stabilit\u00e9 <\/strong>suivantes sont disponibles pour le stockage&nbsp;:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>25 \u00b0C \u00b1 2 \u00b0C \/ 60 % HR \u00b1 5 % HR<\/li>\n\n\n\n<li>30 \u00b0C \u00b1 2 \u00b0C \/ 65 % HR \u00b1 5 % HR<\/li>\n\n\n\n<li>30 \u00b0C \u00b1 2 \u00b0C \/ 75 % HR \u00b1 5 % HR<\/li>\n\n\n\n<li>40 \u00b0C \u00b1 2 \u00b0C \/ 75 % HR \u00b1 5 % HR<\/li>\n\n\n\n<li>40 \u00b0C \u00b1 2 \u00b0C \/ &lt;25 % HR<\/li>\n\n\n\n<li>2 &#8211; 8\u00b0C<\/li>\n\n\n\n<li>&#8211; 15\u00b0C (-20\u00b0C\u00b15\u00b0C)<\/li>\n\n\n\n<li>&#8211; 70\u00b0C (-75\u00b0C\u00b110\u00b0C)<\/li>\n\n\n\n<li>Photostabilit\u00e9 (selon ICH Q1B options 1 et 2)<\/li>\n\n\n\n<li>Stabilit\u00e9 du transport (essais de cycles de cong\u00e9lation et d\u00e9cong\u00e9lation)<\/li>\n\n\n\n<li>Stabilit\u00e9 d&rsquo;utilisation<\/li>\n\n\n\n<li>Conditions sp\u00e9cifiques au client disponibles<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Cycle de cong\u00e9lation \/ d\u00e9cong\u00e9lation<\/strong> : \u00e9value la stabilit\u00e9 et l\u2019int\u00e9grit\u00e9 des produits pharmaceutiques dans diverses conditions thermiques. Il permet de garantir que les produits conservent leur efficacit\u00e9, leur s\u00e9curit\u00e9 et leur qualit\u00e9 m\u00eame apr\u00e8s une exposition \u00e0 des environnements de stockage ou de transport d\u00e9favorables.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Toutes les conditions sont surveill\u00e9es et enregistr\u00e9es en permanence avec des syst\u00e8mes de sauvegarde qui garantissent un environnement totalement s\u00fbr et contr\u00f4l\u00e9. Les alertes d&rsquo;acc\u00e8s et les modifications sont audit\u00e9es et sign\u00e9es \u00e9lectroniquement conform\u00e9ment \u00e0 l&rsquo;annexe 11 des BPF de l&rsquo;UE et \u00e0 la partie 11 du 21 CFR.<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<hr>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-forced-degradation-studies\"><strong><strong>\u00c9tudes de d\u00e9gradation forc\u00e9e<\/strong><\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">La d\u00e9gradation intentionnelle peut \u00eatre un outil utile pour <strong>pr\u00e9dire la stabilit\u00e9 d\u2019un ingr\u00e9dient actif ou d\u2019un m\u00e9dicament ayant des effets sur la puret\u00e9, la puissance et la s\u00e9curit\u00e9<\/strong>. Le type de stress test\u00e9 d\u00e9pend de la substance m\u00e9dicamenteuse et du produit (par exemple, produits oraux solides, poudres lyophilis\u00e9es ou formulations liquides).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">M\u00e9rieux NutriSciences | Pharma &amp; HealthCare r\u00e9alise telles \u00e9tudes sur les produits finis et les API \u00e9valuant les conditions de stress suivantes&nbsp;:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>augmentation de la temp\u00e9rature<\/li>\n\n\n\n<li>conditions acides<\/li>\n\n\n\n<li>conditions alcalines<\/li>\n\n\n\n<li>conditions oxydatives<\/li>\n\n\n\n<li>exposition \u00e0 la lumi\u00e8re<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Les \u00e9tudes peuvent identifier les produits de d\u00e9gradation potentiels et valider les propri\u00e9t\u00e9s indiquant la stabilit\u00e9 de la proc\u00e9dure analytique.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<hr>\n\n\n\n<div 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class=\"card-icon\"\/>\n                                        <div class=\"card-content\">\n                        <span>Emballage pharmaceutique<\/span>\n                    <\/div>\n                <\/a>\n                                <\/div>\n    <\/div>\n<\/div>    \n   \n\n<style>\n.fullwidth-block {\n    max-width: none !important;\n    width: 100vw !important;\n    position: relative;\n    padding:0px;\n    \/* left: 50%;\n    right: 50%;\n    margin-left: -50vw;\n    margin-right: -50vw; *\/\n}\n\n.page-cards-title-container{\n    max-width: 1290px;\n    margin: 100px auto 150px auto;\n    padding-left: var(--global-content-edge-padding);\n    padding-right: var(--global-content-edge-padding);\n}\n.page-cards-title-container h2{\n    color:var(--global-palette4);\n    text-align: center;\n}\n.full-width-row-page-cards-wrapper{\n    background-color: var(--global-palette4);\n}\n.page-cards-container{\n    max-width:1290px;\n    margin: 0 auto;\n    display: flex;\n    gap: 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Notre Laboratoire d\u00e9di\u00e9 aux \u00e9tudes de stabilit\u00e9 pharmaceutiques&#8230;<\/p>\n","protected":false},"author":43,"featured_media":177022,"parent":202375,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"service-page-pharma-blue.php","meta":{"_acf_changed":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","footnotes":""},"folder":[],"class_list":["post-202991","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"taxonomy_info":[],"featured_image_src_large":["https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2025\/07\/shutterstock_90590236_mod-1024x326.jpg",1024,326,true],"author_info":{"display_name":"Morgan","author_link":"https:\/\/www.merieuxnutrisciences.com\/fr\/author\/morgan\/"},"comment_info":0,"_links":{"self":[{"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/pages\/202991","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/users\/43"}],"replies":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/comments?post=202991"}],"version-history":[{"count":14,"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/pages\/202991\/revisions"}],"predecessor-version":[{"id":205273,"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/pages\/202991\/revisions\/205273"}],"up":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/pages\/202375"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/media\/177022"}],"wp:attachment":[{"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/media?parent=202991"}],"wp:term":[{"taxonomy":"folder","embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/fr\/wp-json\/wp\/v2\/folder?post=202991"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}