{"id":2742,"date":"2023-08-08T15:13:04","date_gmt":"2023-08-08T14:13:04","guid":{"rendered":"https:\/\/vosfoxmedical.com\/validation\/validation-du-nettoyage\/"},"modified":"2024-10-09T12:01:56","modified_gmt":"2024-10-09T11:01:56","slug":"validation-du-nettoyage","status":"publish","type":"page","link":"https:\/\/vosfoxmedical.com\/fr\/services-2\/validation\/validation-du-nettoyage\/","title":{"rendered":"Validation du nettoyage"},"content":{"rendered":"\t<section class=\"section dark\" id=\"section_2087643977\">\n\t\t<div class=\"bg section-bg fill bg-fill  \" >\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-2079325275\">\n\n\t<div id=\"col-1373023623\" 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-2687535015\" class=\"text\">\n\t\t\n<h1 class=\"entry-title\"><span style=\"font-size: 100%;\">Validation du nettoyage<\/span><\/h1>\n\t\t\n<style>\n#text-2687535015 {\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_2087643977 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  min-height: 400px;\n  background-color: #5a0958;\n}\n#section_2087643977 .section-bg-overlay {\n  background-color: rgba(90, 9, 88, 0.89);\n}\n#section_2087643977 .section-bg.bg-loaded {\n  background-image: url(https:\/\/vosfoxmedical.com\/wp-content\/uploads\/2021\/06\/img-thunderstorm.jpg);\n}\n#section_2087643977 .section-bg {\n  background-position: 90% 59%;\n}\n#section_2087643977 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#section_2087643977 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #section_2087643977 {\n    min-height: 400px;\n  }\n}\n@media (min-width:850px) {\n  #section_2087643977 {\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-1825146342\">\n\n\t<div id=\"col-96715437\" 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-499557572\">\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-499557572 {\n  padding-top: 300px;\n  background-color: rgb(255,255,255);\n}\n#banner-499557572 .bg.bg-loaded {\n  background-image: url(https:\/\/vosfoxmedical.com\/wp-content\/uploads\/2021\/06\/photo-facilities.jpg);\n}\n#banner-499557572 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-499557572 .ux-shape-divider--bottom svg {\n  height: 150px;\n  --divider-width: 100%;\n}\n@media (min-width:550px) {\n  #banner-499557572 {\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-96715437 > .col-inner {\n  margin: -120px 0px 0px 0px;\n}\n@media (min-width:550px) {\n  #col-96715437 > .col-inner {\n    margin: -120px 0px 0px 0px;\n  }\n}\n@media (min-width:850px) {\n  #col-96715437 > .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_440881846\">\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-157944477\">\n\n\t<div id=\"col-1885303303\" 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\">La validation du nettoyage est importante pour pr\u00e9venir la contamination (crois\u00e9e) des produits au cours de la fabrication.<br \/>\nTous les types de contamination doivent \u00eatre identifi\u00e9s (au cours de l&rsquo;analyse des risques).<br \/>\nLe plus souvent, la contamination est due \u00e0 un changement de mat\u00e9riau sur la machine, et la machine doit \u00eatre nettoy\u00e9e avant de commencer la nouvelle production.<br \/>\nCe processus de nettoyage doit \u00eatre valid\u00e9.<br \/>\nLa validation du nettoyage suit les m\u00eames \u00e9tapes (IQ, OQ et PQ) que la validation du processus, mais le contenu de ces \u00e9tapes diff\u00e8re.<br \/>\nVous trouverez ci-dessous une description de quelques \u00e9tapes possibles.     <\/p>\n\t<div id=\"gap-2013739832\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2013739832 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-356157773\">\n\n\t<div id=\"col-1034638802\" 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-1755676889\">\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-698234362\" 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-698234362 {\n  width: 60%;\n}\n#text-box-698234362 .text-box-content {\n  font-size: 100%;\n}\n<\/style>\n    <\/div>\n \n        <\/div>\n      <\/div>\n\n            \n<style>\n#banner-1755676889 {\n  padding-top: 363px;\n}\n#banner-1755676889 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-agar-plates.jpg?fit=768%2C384&ssl=1);\n}\n#banner-1755676889 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-1755676889 .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-439395679\" 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<p>&nbsp;<\/p>\n<h2 id=\"types-of-sampling-methods-3\">Types de m\u00e9thodes d&rsquo;\u00e9chantillonnage<\/h2>\n<p>La mani\u00e8re dont le nettoyage doit \u00eatre valid\u00e9 n&rsquo;est pas d\u00e9finie, mais il est g\u00e9n\u00e9ralement admis dans l&rsquo;industrie qu&rsquo;il existe deux types de m\u00e9thodes d&rsquo;\u00e9chantillonnage pour la validation du nettoyage : directe et indirecte.<\/p>\n<ul>\n<li aria-level=\"1\">L&rsquo;<strong>\u00e9chantillonnage direct pour la validation du nettoyage<\/strong> est \u00e9galement connu sous le nom de m\u00e9thode de l&rsquo;\u00e9couvillon, qui consiste \u00e0 frotter syst\u00e9matiquement un mat\u00e9riau st\u00e9rile sur une surface \u00e0 analyser pour y d\u00e9celer la pr\u00e9sence de r\u00e9sidus.<\/li>\n<li aria-level=\"1\">L&rsquo;<strong>\u00e9chantillonnage indirect pour la validation du nettoyage<\/strong> est souvent appel\u00e9 \u00e9chantillonnage par rin\u00e7age, o\u00f9 un solvant comme l&rsquo;eau est rinc\u00e9 dans une zone sp\u00e9cifique de la surface propre et test\u00e9 pour des traces de contaminants.<\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t<div id=\"gap-442616545\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-442616545 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-1849259011\">\n\n\t<div id=\"col-1395930895\" 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 id=\"types-of-cleaning-methods-4\">Types de m\u00e9thodes de nettoyage<\/h2>\n<p>Il existe de nombreux types de m\u00e9thodes de nettoyage, qui d\u00e9pendent en grande partie de votre processus.<br \/>\nVoici une liste des m\u00e9thodes possibles. <\/p>\n<ul>\n<li aria-level=\"1\"><strong>M\u00e9thode de nettoyage en place &#8211;<\/strong> normalement \u00e0 l&rsquo;aide de dispositifs de pulv\u00e9risation fixes ou rotatifs avec un r\u00e9servoir de lavage, une pompe de recirculation et la tuyauterie associ\u00e9e.\n<ul>\n<li aria-level=\"1\"><strong>Purge &#8211; <\/strong> Forme de la m\u00e9thode de nettoyage en place qui consiste \u00e0 remplacer un composant par un autre.<\/li>\n<\/ul>\n<\/li>\n<li aria-level=\"1\"><strong>M\u00e9thode de nettoyage sur place &#8211;<\/strong> souvent utilis\u00e9e pour le lavage automatis\u00e9 de pi\u00e8ces dans des armoires ou des tunnels de lavage avec des cycles de nettoyage, de rin\u00e7age et de s\u00e9chage.<\/li>\n<li aria-level=\"1\"><strong>M\u00e9thode d&rsquo;immersion &#8211; <\/strong> soit agit\u00e9e, lorsqu&rsquo;un agent de nettoyage dans un r\u00e9cipient de traitement est stimul\u00e9 m\u00e9caniquement pour obtenir un effet de nettoyage, soit statique, lorsque le r\u00e9cipient de traitement est simplement imbib\u00e9 de l&rsquo;agent de nettoyage.<\/li>\n<li aria-level=\"1\"><strong>Lavage par ultrasons &#8211; ce<\/strong> proc\u00e9d\u00e9 est g\u00e9n\u00e9ralement plus efficace pour les pi\u00e8ces complexes telles que les aiguilles de remplissage, car il fait appel \u00e0 une cuve \u00e9quip\u00e9e de transducteurs \u00e0 ultrasons pour induire une cavitation.<\/li>\n<li aria-level=\"1\"><strong>Pulv\u00e9risation \u00e0 haute pression &#8211;<\/strong> d\u00e9loge les r\u00e9sidus pr\u00e9sents sur la surface gr\u00e2ce \u00e0 de l&rsquo;eau ou \u00e0 une solution de nettoyage \u00e0 haute pression, en continu et de mani\u00e8re cibl\u00e9e.<\/li>\n<li aria-level=\"1\"><strong>Nettoyage manuel &#8211;<\/strong> g\u00e9n\u00e9ralement la m\u00e9thode de nettoyage la plus difficile \u00e0 valider ; comprend les trois techniques les plus courantes : essuyage, brossage de l&rsquo;\u00e9vier et brossage de l&rsquo;\u00e9quipement.<\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-1292714910\" 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-1945974974\">\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-1945974974 {\n  padding-top: 602px;\n}\n#banner-1945974974 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/08\/types-of-all-purpose-cleaners-April232020-1-min.jpg?fit=1000%2C665&ssl=1);\n}\n#banner-1945974974 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-1945974974 .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-567333258\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-567333258 {\n  padding-top: 30px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-892332069\">\n\n\t<div id=\"col-137154160\" 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-222169027\">\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-222169027 {\n  padding-top: 438px;\n}\n#banner-222169027 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-iqoqpq.jpg?fit=691%2C601&ssl=1);\n}\n#banner-222169027 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-222169027 .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-2057290243\" 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 id=\"acceptance-criteria-5\">Crit\u00e8res d&rsquo;acceptation<\/h2>\n<p>Pour d\u00e9terminer les r\u00e9sultats de l&rsquo;\u00e9tude, il est essentiel de d\u00e9finir avec pr\u00e9cision les crit\u00e8res d&rsquo;acceptation de la limite de validation du nettoyage.<br \/>\nPour mieux \u00e9valuer l&rsquo;efficacit\u00e9 des m\u00e9thodes de nettoyage, les crit\u00e8res d&rsquo;acceptation de la validation du nettoyage peuvent g\u00e9n\u00e9ralement \u00eatre class\u00e9s en trois cat\u00e9gories de param\u00e8tres d&rsquo;essai : <\/p>\n<ul>\n<li aria-level=\"1\"><strong>Crit\u00e8re physique :<\/strong> une inspection visuelle de l&rsquo;\u00e9quipement doit r\u00e9v\u00e9ler l&rsquo;absence de particules ou de r\u00e9sidus.<\/li>\n<li aria-level=\"1\"><strong>Crit\u00e8re chimique :<\/strong> un nombre maximum de ppms (parties par million) d&rsquo;un produit peut \u00eatre d\u00e9tect\u00e9 dans un autre produit.<\/li>\n<li aria-level=\"1\"><strong>Crit\u00e8re microbien :<\/strong> pas plus de x CFU (colony-forming units) pour la num\u00e9ration bact\u00e9rienne (totale ou par surface) et pas plus de y CFU pour les moisissures dans un \u00e9chantillon.<\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t<div id=\"gap-809179154\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-809179154 {\n  padding-top: 70px;\n}\n<\/style>\n\t<\/div>\n\t\n<div class=\"row\"  id=\"row-841953298\">\n\n\t<div id=\"col-1326385104\" 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>Documents requis<\/h2>\n<ul>\n<li aria-level=\"1\">Des proc\u00e9dures op\u00e9rationnelles normalis\u00e9es<a href=\"https:\/\/safetyculture.com\/checklists\/standard-operating-procedure\/\" rel=\"noopener noreferrer\">(POS)<\/a> \u00e9crites pour les processus de nettoyage de l&rsquo;\u00e9quipement qui r\u00e9pondent \u00e0 diff\u00e9rents sc\u00e9narios (par exemple, un processus pour diff\u00e9rents lots, diff\u00e9rents processus entre les changements de produits, etc.)<\/li>\n<li aria-level=\"1\">Proc\u00e9dures \u00e9crites de validation du nettoyage, y compris la personne responsable de l&rsquo;ex\u00e9cution et de l&rsquo;approbation de l&rsquo;\u00e9tude de validation, les crit\u00e8res d&rsquo;acceptation et le moment o\u00f9 une revalidation sera n\u00e9cessaire.<\/li>\n<li aria-level=\"1\">Des protocoles \u00e9crits de validation du nettoyage pour l&rsquo;inspection de chaque pi\u00e8ce d&rsquo;\u00e9quipement qui traitent des questions courantes (par exemple, les proc\u00e9dures d&rsquo;\u00e9chantillonnage, les m\u00e9thodes analytiques, etc.), la r\u00e9alisation de la validation conform\u00e9ment aux protocoles et la documentation de ses r\u00e9sultats.<\/li>\n<li aria-level=\"1\">Rapport final de validation du nettoyage indiquant si le processus de nettoyage d&rsquo;un \u00e9quipement ou d&rsquo;un syst\u00e8me de fabrication sp\u00e9cifique est valable ou non.<\/li>\n<\/ul>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n\t<div id=\"col-2116951945\" 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-590216193\">\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-590216193 {\n  padding-top: 360px;\n}\n#banner-590216193 .bg.bg-loaded {\n  background-image: url(https:\/\/i0.wp.com\/vosfoxmedical.com\/wp-content\/uploads\/2023\/05\/img-documents.png?fit=1020%2C452&ssl=1);\n}\n#banner-590216193 .ux-shape-divider--top svg {\n  height: 150px;\n  --divider-top-width: 100%;\n}\n#banner-590216193 .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<div class=\"row\"  id=\"row-526932158\">\n\n\t<div id=\"col-1425458612\" 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\/fr\/?page_id=2510\" 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_440881846 {\n  padding-top: 30px;\n  padding-bottom: 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