{"id":2850,"date":"2023-05-15T15:07:22","date_gmt":"2023-05-15T14:07:22","guid":{"rendered":"https:\/\/vosfoxmedical.com\/validation\/validation-de-lemballage-et-du-transport\/"},"modified":"2024-10-09T13:01:49","modified_gmt":"2024-10-09T12:01:49","slug":"validation-de-lemballage-et-du-transport","status":"publish","type":"page","link":"https:\/\/vosfoxmedical.com\/fr\/services-2\/validation\/validation-de-lemballage-et-du-transport\/","title":{"rendered":"Validation de l&#8217;emballage et du transport"},"content":{"rendered":"\t<section class=\"section dark\" id=\"section_1836030187\">\n\t\t<div class=\"bg section-bg fill bg-fill  bg-loaded\" >\n\n\t\t\t\n\t\t\t<div class=\"section-bg-overlay absolute fill\"><\/div>\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row\" style=\"max-width:1300px\" id=\"row-985398158\">\n\n\t<div id=\"col-893938575\" class=\"col medium-12 small-12 large-8\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"text-1639834150\" class=\"text\">\n\t\t\n<h1 class=\"entry-title\">Validation de l&#8217;emballage et du transport<\/h1>\n\t\t\n<style>\n#text-1639834150 {\n  font-size: 2.75rem;\n}\n<\/style>\n\t<\/div>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1836030187 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  min-height: 400px;\n  background-color: rgb(239, 167, 0);\n}\n#section_1836030187 .section-bg-overlay {\n  background-color: rgba(239, 167, 0, 0.773);\n}\n#section_1836030187 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_1836030187 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #section_1836030187 {\n    min-height: 400px;\n  }\n}\n@media (min-width:850px) {\n  #section_1836030187 {\n    min-height: 600px;\n  }\n}\n<\/style>\n\t<\/section>\n\t\n<div class=\"row align-bottom\" style=\"max-width:1300px\" id=\"row-1762471498\">\n\n\t<div id=\"col-1386792706\" class=\"col medium-12 small-12 large-4\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-1028601212\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1028601212 {\n  padding-top: 0px;\n}\n@media (min-width:550px) {\n  #gap-1028601212 {\n    padding-top: 0px;\n  }\n}\n@media (min-width:850px) {\n  #gap-1028601212 {\n    padding-top: 35px;\n  }\n}\n<\/style>\n\t<\/div>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1353570135\" class=\"col medium-12 small-12 large-8 medium-col-first\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-276877376\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-276877376 {\n  padding-top: 300px;\n  background-color: rgb(255,255,255);\n}\n#banner-276877376 .bg.bg-loaded {\n  background-image: url(https:\/\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/photo-packaging-validation.jpg);\n}\n#banner-276877376 .bg {\n  background-position: 68% 94%;\n}\n#banner-276877376 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-276877376 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #banner-276877376 {\n    padding-top: 600px;\n  }\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1353570135 > .col-inner {\n  margin: -120px 0px 0px 0px;\n}\n@media (min-width:550px) {\n  #col-1353570135 > .col-inner {\n    margin: -120px 0px 0px 0px;\n  }\n}\n@media (min-width:850px) {\n  #col-1353570135 > .col-inner {\n    margin: -500px 0px 0px 0px;\n  }\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n\t<section class=\"section\" id=\"section_419946031\">\n\t\t<div class=\"bg section-bg fill bg-fill  bg-loaded\" >\n\n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row row-large align-equal align-right\"  id=\"row-482226448\">\n\n\t<div id=\"col-1039524092\" class=\"col medium-12 small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<p class=\"lead\">Lorsque la validation de l&#8217;emballage et du transport est n\u00e9cessaire, Vosfox Medical peut vous aider \u00e0 r\u00e9diger le protocole et \u00e0 organiser les tests.<br \/>\nNous pouvons suivre des normes telles que ISO 11607 ou ASTM D-4169. <\/p>\n<p class=\"lead\">La directive sur les dispositifs m\u00e9dicaux \u00e9nonce les exigences relatives \u00e0 l&#8217;emballage des dispositifs m\u00e9dicaux ;<\/p>\n<ul>\n<li>\n<p class=\"lead\">Les dispositifs doivent \u00eatre emball\u00e9s de mani\u00e8re \u00e0 ce que leurs caract\u00e9ristiques et leurs performances dans le cadre de l&rsquo;utilisation pr\u00e9vue ne soient pas alt\u00e9r\u00e9es pendant le transport et le stockage.<\/p>\n<\/li>\n<li>\n<p class=\"lead\">Les dispositifs pr\u00e9sentant un \u00e9tat microbien sp\u00e9cifique doivent \u00eatre emball\u00e9s de mani\u00e8re \u00e0 garantir qu&rsquo;ils restent dans cet \u00e9tat lorsqu&rsquo;ils sont mis sur le march\u00e9 dans des conditions de transport et de stockage.<\/p>\n<\/li>\n<li>\n<p class=\"lead\">L&#8217;emballage doit garantir qu&rsquo;il reste st\u00e9rile jusqu&rsquo;\u00e0 ce qu&rsquo;il soit bris\u00e9.<\/p>\n<\/li>\n<\/ul>\n\t<div id=\"gap-1188489415\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1188489415 {\n  padding-top: 70px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-647845192\">\n\n\t<div id=\"col-1619194181\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-107953351\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n   <div id=\"text-box-746973889\" class=\"text-box banner-layer x50 md-x50 lg-x50 y50 md-y50 lg-y50 res-text\">\n                                <div class=\"text-box-content text dark\">\n              \n              <div class=\"text-inner text-center\">\n                  \n              <\/div>\n           <\/div>\n                            \n<style>\n#text-box-746973889 {\n  width: 60%;\n}\n#text-box-746973889 .text-box-content {\n  font-size: 100%;\n}\n<\/style>\n    <\/div>\n \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-107953351 {\n  padding-top: 471px;\n}\n#banner-107953351 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-seal-strength.jpg?fit=950%2C633&ssl=1);\n}\n#banner-107953351 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-107953351 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1619376441\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Validation de l&#8217;emballage &#8211; Int\u00e9grit\u00e9 du scellage<\/h2>\n<p>  Lorsqu&rsquo;un produit doit \u00eatre st\u00e9rilis\u00e9, il doit rester st\u00e9rile apr\u00e8s le processus de st\u00e9rilisation.<br \/>\nC&rsquo;est pourquoi un type d&#8217;emballage \u00e0 barri\u00e8re st\u00e9rile est choisi et test\u00e9.<br \/>\nLes scell\u00e9s des sachets ou des blisters doivent \u00eatre de bonne qualit\u00e9 pour maintenir la fonction de barri\u00e8re st\u00e9rile.<br \/>\nLes tests des scell\u00e9s consistent en une inspection visuelle, v\u00e9rifiant les points suivants     <\/p>\n<ul>\n<li>zones non scell\u00e9es<\/li>\n<li>les zones non homog\u00e8nes ou non scell\u00e9es<\/li>\n<li>zones recouvertes<\/li>\n<li>joints \u00e9troits<\/li>\n<li>canaux<\/li>\n<li>des rides, des plis ou des fissures<\/li>\n<li>des d\u00e9chirures ou des trous d&rsquo;\u00e9pingle<\/li>\n<\/ul>\n<p>  Cette \u00e9tape est suivie d&rsquo;un essai d&rsquo;int\u00e9grit\u00e9 du joint, g\u00e9n\u00e9ralement un essai de traction.<br \/>\nLa r\u00e9sistance minimale requise du joint comme crit\u00e8re d&rsquo;acceptation est compar\u00e9e aux r\u00e9sultats d&rsquo;une s\u00e9rie d&rsquo;\u00e9chantillons.<\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t<div id=\"gap-1341070506\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1341070506 {\n  padding-top: 70px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-463904097\">\n\n\t<div id=\"col-1929870854\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Validation de l&#8217;emballage &#8211; int\u00e9grit\u00e9 de l&#8217;emballage<\/h2>\n<p>  Il existe plusieurs types de tests d&rsquo;int\u00e9grit\u00e9.<br \/>\nCes tests portent sur l&rsquo;int\u00e9grit\u00e9 totale de l&#8217;emballage, et pas seulement sur le scell\u00e9.<br \/>\nLes types d&rsquo;essais les plus courants sont les suivants :    <\/p>\n<ul>\n<li>test d&rsquo;\u00e9tanch\u00e9it\u00e9 \u00e0 la bulle<\/li>\n<li>test de d\u00e9sint\u00e9gration sous vide<\/li>\n<li>essais de p\u00e9n\u00e9tration des colorants<\/li>\n<li>l&rsquo;essai d&rsquo;\u00e9clatement.<\/li>\n<\/ul>\n<p>  L&rsquo;int\u00e9grit\u00e9 du scellage et de l&#8217;emballage doit \u00eatre test\u00e9e pendant toute la dur\u00e9e de conservation.<br \/>\nLes tests choisis sont effectu\u00e9s au moment 0 et \u00e0 des moments choisis pour les tests acc\u00e9l\u00e9r\u00e9s et en temps r\u00e9el.<\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1323862680\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-1016451465\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n   <div id=\"text-box-513458916\" class=\"text-box banner-layer x50 md-x50 lg-x50 y50 md-y50 lg-y50 res-text\">\n                                <div class=\"text-box-content text dark\">\n              \n              <div class=\"text-inner text-center\">\n                  \n              <\/div>\n           <\/div>\n                            \n<style>\n#text-box-513458916 {\n  width: 60%;\n}\n#text-box-513458916 .text-box-content {\n  font-size: 100%;\n}\n<\/style>\n    <\/div>\n \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-1016451465 {\n  padding-top: 400px;\n}\n#banner-1016451465 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-bubble-leak-tester.png?fit=1000%2C600&ssl=1);\n}\n#banner-1016451465 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-1016451465 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t<div id=\"gap-2100298093\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2100298093 {\n  padding-top: 70px;\n}\n<\/style>\n\t<\/div>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-460316198\">\n\n\t<div id=\"col-68252505\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n  <div class=\"banner has-hover\" id=\"banner-149558036\">\n          <div class=\"banner-inner fill\">\n        <div class=\"banner-bg fill\" >\n            <div class=\"bg fill bg-fill \"><\/div>\n                                    \n                    <\/div>\n\t\t\n        <div class=\"banner-layers container\">\n            <div class=\"fill banner-link\"><\/div>            \n   <div id=\"text-box-735268198\" class=\"text-box banner-layer x50 md-x50 lg-x50 y50 md-y50 lg-y50 res-text\">\n                                <div class=\"text-box-content text dark\">\n              \n              <div class=\"text-inner text-center\">\n                  \n              <\/div>\n           <\/div>\n                            \n<style>\n#text-box-735268198 {\n  width: 60%;\n}\n#text-box-735268198 .text-box-content {\n  font-size: 100%;\n}\n<\/style>\n    <\/div>\n \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-149558036 {\n  padding-top: 489px;\n}\n#banner-149558036 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-transport-testing.jpg?fit=400%2C266&ssl=1);\n}\n#banner-149558036 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-149558036 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n<\/style>\n  <\/div>\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-349004937\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>Validation des transports<\/h2>\n<p>  Le type d&rsquo;essai de transport d\u00e9pend du risque d&rsquo;endommagement du produit ou de l&#8217;emballage et du mode de transport.<br \/>\nIl est possible d&rsquo;effectuer des tests de chute ou d&rsquo;agitation.<br \/>\nLes tests de validation peuvent \u00e9galement comprendre des tests de transport en temps r\u00e9el, l&rsquo;utilisation de courriers standard et l&rsquo;envoi de colis aux endroits les plus incertains.<br \/>\nIl est \u00e9galement possible d&rsquo;effectuer des tests en laboratoire conform\u00e9ment \u00e0 la norme ASTM D4169, en r\u00e9alisant les tests suivants :     <\/p>\n<ul>\n<li>Test de chute<\/li>\n<li>Test de vibration<\/li>\n<li>Essai de compression\/ Empilage de v\u00e9hicules<\/li>\n<li>Test d&rsquo;altitude<\/li>\n<li>Test des conditions climatiques<\/li>\n<li>Essais d&rsquo;impact horizontal<\/li>\n<\/ul>\n<p>  Avec votre sp\u00e9cialiste en r\u00e9glementation, nous pouvons discuter des tests n\u00e9cessaires.<\/p>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1657629135\">\n\n\t<div id=\"col-1489050814\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-455065492\" class=\"col medium-6 small-12 large-6\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/vosfoxmedical.com\/services\/\" target=\"_self\" class=\"button primary\"  >\n    <span>Retour \u00e0 la page de pr\u00e9sentation du d\u00e9veloppement de la pr\u00e9production<\/span>\n  <\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_419946031 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n}\n#section_419946031 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_419946031 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #section_419946031 {\n    padding-top: 70px;\n    padding-bottom: 70px;\n  }\n}\n<\/style>\n\t<\/section>\n\t\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":3,"featured_media":0,"parent":2510,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-blank.php","meta":{"footnotes":""},"class_list":["post-2850","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.2 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Validation de l&#039;emballage et du transport<\/title>\n<meta name=\"description\" content=\"L&#039;une des \u00e9tapes n\u00e9cessaires \u00e0 la production de produits \u00e0 usage clinique est la validation de l&#039;emballage et du transport. 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