{"id":858,"count":4,"description":"<p style=\"text-align: left\" data-start=\"216\" data-end=\"329\"><strong data-start=\"218\" data-end=\"329\">Lavage pharmaceutique : proc\u00e9d\u00e9s avanc\u00e9s et Cleaning Validation selon les r\u00e9glementations les plus r\u00e9centes<\/strong><\/p>\r\n<p style=\"text-align: left\" data-start=\"331\" data-end=\"844\">Le <strong data-start=\"334\" data-end=\"359\">lavage pharmaceutique<\/strong> repr\u00e9sente une \u00e9tape critique au sein des processus de production de l\u2019industrie pharmaceutique, des dispositifs m\u00e9dicaux et des biotechnologies. Un syst\u00e8me de lavage efficace ne se limite pas \u00e0 l\u2019\u00e9limination des r\u00e9sidus visibles, mais doit garantir l\u2019<strong data-start=\"612\" data-end=\"710\">\u00e9limination r\u00e9p\u00e9table et valid\u00e9e des contaminants chimiques, microbiologiques et particulaires<\/strong>, dans le plein respect des <strong data-start=\"738\" data-end=\"761\">r\u00e9glementations GMP<\/strong> et des lignes directrices les plus r\u00e9centes en mati\u00e8re de <strong data-start=\"820\" data-end=\"843\">Cleaning Validation<\/strong>.<\/p>\r\n<p style=\"text-align: left\" data-start=\"846\" data-end=\"1125\"><span class=\"hover:entity-accent entity-underline inline cursor-pointer align-baseline\"><span class=\"whitespace-normal\">De Lama<\/span><\/span> con\u00e7oit et fabrique des <strong data-start=\"908\" data-end=\"979\">syst\u00e8mes de lavage industriels et pharmaceutiques haute performance<\/strong>, capables de r\u00e9pondre aux exigences les plus strictes en termes <strong data-start=\"1044\" data-end=\"1124\">d\u2019efficacit\u00e9, de r\u00e9p\u00e9tabilit\u00e9, de tra\u00e7abilit\u00e9 et de conformit\u00e9 r\u00e9glementaire<\/strong>.<\/p>\r\n\r\n\r\n<hr data-start=\"1127\" data-end=\"1130\" \/>\r\n<p data-start=\"1132\" data-end=\"1202\">[read more]<\/p>\r\n\r\n<h2 style=\"text-align: left\" data-start=\"1132\" data-end=\"1202\"><strong data-start=\"1135\" data-end=\"1202\">Le r\u00f4le strat\u00e9gique du lavage dans les proc\u00e9d\u00e9s pharmaceutiques<\/strong><\/h2>\r\n<p style=\"text-align: left\" data-start=\"1204\" data-end=\"1389\">Dans le contexte pharmaceutique moderne, le lavage n\u2019est plus une simple \u00e9tape pr\u00e9liminaire \u00e0 la st\u00e9rilisation, mais un <strong data-start=\"1324\" data-end=\"1359\">proc\u00e9d\u00e9 critique et ind\u00e9pendant<\/strong>, ayant un impact direct sur :<\/p>\r\n\r\n<ul style=\"text-align: left\" data-start=\"1391\" data-end=\"1546\">\r\n \t<li data-start=\"1391\" data-end=\"1425\">\r\n<p data-start=\"1393\" data-end=\"1425\"><strong data-start=\"1393\" data-end=\"1423\">la qualit\u00e9 du produit fini<\/strong><\/p>\r\n<\/li>\r\n \t<li data-start=\"1426\" data-end=\"1456\">\r\n<p data-start=\"1428\" data-end=\"1456\"><strong data-start=\"1428\" data-end=\"1454\">la s\u00e9curit\u00e9 du patient<\/strong><\/p>\r\n<\/li>\r\n \t<li data-start=\"1457\" data-end=\"1492\">\r\n<p data-start=\"1459\" data-end=\"1492\"><strong data-start=\"1459\" data-end=\"1490\">la conformit\u00e9 r\u00e9glementaire<\/strong><\/p>\r\n<\/li>\r\n \t<li data-start=\"1493\" data-end=\"1546\">\r\n<p data-start=\"1495\" data-end=\"1546\"><strong data-start=\"1495\" data-end=\"1546\">la r\u00e9duction du risque de contamination crois\u00e9e<\/strong><\/p>\r\n<\/li>\r\n<\/ul>\r\n<p style=\"text-align: left\" data-start=\"1548\" data-end=\"1840\">Des composants tels que <strong data-start=\"1572\" data-end=\"1748\">les pi\u00e8ces de machines, les outils, les accessoires de proc\u00e9d\u00e9, les contenants, les plateaux, les chariots, les composants de lignes aseptiques et les syst\u00e8mes de transfert<\/strong> doivent \u00eatre lav\u00e9s selon des <strong data-start=\"1778\" data-end=\"1839\">proc\u00e9d\u00e9s r\u00e9p\u00e9tables, validables et enti\u00e8rement document\u00e9s<\/strong>.<\/p>\r\n\r\n\r\n<hr data-start=\"1842\" data-end=\"1845\" \/>\r\n\r\n<h2 style=\"text-align: left\" data-start=\"1847\" data-end=\"1904\"><strong data-start=\"1850\" data-end=\"1904\">Fonctionnement du proc\u00e9d\u00e9 de lavage pharmaceutique<\/strong><\/h2>\r\n<p style=\"text-align: left\" data-start=\"1906\" data-end=\"2072\">Le proc\u00e9d\u00e9 de lavage pharmaceutique repose sur une combinaison contr\u00f4l\u00e9e de <strong data-start=\"1982\" data-end=\"2047\">l\u2019action m\u00e9canique, chimique et thermique, ainsi que du temps<\/strong>, optimis\u00e9e en fonction :<\/p>\r\n\r\n<ul style=\"text-align: left\" data-start=\"2074\" data-end=\"2161\">\r\n \t<li data-start=\"2074\" data-end=\"2100\">\r\n<p data-start=\"2076\" data-end=\"2100\">du type de contaminant<\/p>\r\n<\/li>\r\n \t<li data-start=\"2101\" data-end=\"2126\">\r\n<p data-start=\"2103\" data-end=\"2126\">du mat\u00e9riau \u00e0 traiter<\/p>\r\n<\/li>\r\n \t<li data-start=\"2127\" data-end=\"2161\">\r\n<p data-start=\"2129\" data-end=\"2161\">de la g\u00e9om\u00e9trie des composants<\/p>\r\n<\/li>\r\n<\/ul>\r\n<h3 style=\"text-align: left\" data-start=\"2163\" data-end=\"2208\"><strong data-start=\"2167\" data-end=\"2208\">Un cycle de lavage typique comprend :<\/strong><\/h3>\r\n<ol style=\"text-align: left\" data-start=\"2210\" data-end=\"2851\">\r\n \t<li data-start=\"2210\" data-end=\"2295\">\r\n<p data-start=\"2213\" data-end=\"2295\"><strong data-start=\"2213\" data-end=\"2227\">Pr\u00e9-lavage<\/strong><br data-start=\"2227\" data-end=\"2230\" \/>\u00c9limination des r\u00e9sidus grossiers et pr\u00e9paration des surfaces.<\/p>\r\n<\/li>\r\n \t<li data-start=\"2297\" data-end=\"2487\">\r\n<p data-start=\"2300\" data-end=\"2487\"><strong data-start=\"2300\" data-end=\"2325\">Lavage avec d\u00e9tergent<\/strong><br data-start=\"2325\" data-end=\"2328\" \/>Action chimique et m\u00e9canique visant \u00e0 \u00e9liminer les r\u00e9sidus de produit, les <strong data-start=\"2406\" data-end=\"2413\">API<\/strong>, les excipients, les huiles, les graisses et les contaminants organiques.<\/p>\r\n<\/li>\r\n \t<li data-start=\"2489\" data-end=\"2571\">\r\n<p data-start=\"2492\" data-end=\"2571\"><strong data-start=\"2492\" data-end=\"2519\">Rin\u00e7ages interm\u00e9diaires<\/strong><br data-start=\"2519\" data-end=\"2522\" \/>\u00c9limination compl\u00e8te des r\u00e9sidus de d\u00e9tergent.<\/p>\r\n<\/li>\r\n \t<li data-start=\"2573\" data-end=\"2673\">\r\n<p data-start=\"2576\" data-end=\"2673\"><strong data-start=\"2576\" data-end=\"2593\">Rin\u00e7age final<\/strong><br data-start=\"2593\" data-end=\"2596\" \/>R\u00e9alis\u00e9 avec de l\u2019<strong data-start=\"2617\" data-end=\"2651\">eau qualifi\u00e9e (PW, HPW ou WFI)<\/strong>, selon l\u2019application.<\/p>\r\n<\/li>\r\n \t<li data-start=\"2675\" data-end=\"2851\">\r\n<p data-start=\"2678\" data-end=\"2851\"><strong data-start=\"2678\" data-end=\"2689\">S\u00e9chage<\/strong><br data-start=\"2689\" data-end=\"2692\" \/>Contr\u00f4l\u00e9 et r\u00e9p\u00e9table, afin de pr\u00e9venir toute recontamination et de garantir la disponibilit\u00e9 imm\u00e9diate des composants pour les \u00e9tapes suivantes du proc\u00e9d\u00e9.<\/p>\r\n<\/li>\r\n<\/ol>\r\n<p style=\"text-align: left\" data-start=\"2853\" data-end=\"3058\">Les syst\u00e8mes de lavage De Lama assurent un <strong data-start=\"2896\" data-end=\"2959\">contr\u00f4le pr\u00e9cis de tous les param\u00e8tres critiques du proc\u00e9d\u00e9<\/strong>, y compris <strong data-start=\"2971\" data-end=\"3057\">la pression, le d\u00e9bit, la temp\u00e9rature, le temps et la concentration des d\u00e9tergents<\/strong>.<\/p>\r\n\r\n\r\n<hr data-start=\"3060\" data-end=\"3063\" \/>\r\n\r\n<h2 style=\"text-align: left\" data-start=\"3065\" data-end=\"3110\"><strong data-start=\"3068\" data-end=\"3110\">Lavage et nouvelle Cleaning Validation<\/strong><\/h2>\r\n<p style=\"text-align: left\" data-start=\"3112\" data-end=\"3310\">Les \u00e9volutions r\u00e9glementaires r\u00e9centes ont renforc\u00e9 le r\u00f4le de la <strong data-start=\"3178\" data-end=\"3201\">Cleaning Validation<\/strong>, qui exige aujourd\u2019hui une approche <strong data-start=\"3238\" data-end=\"3309\">scientifique, bas\u00e9e sur le risque et sur la r\u00e9p\u00e9tabilit\u00e9 du proc\u00e9d\u00e9<\/strong>.<\/p>\r\n<p style=\"text-align: left\" data-start=\"3312\" data-end=\"3364\">Un syst\u00e8me de lavage pharmaceutique doit permettre :<\/p>\r\n\r\n<ul style=\"text-align: left\" data-start=\"3366\" data-end=\"3623\">\r\n \t<li data-start=\"3366\" data-end=\"3431\">\r\n<p data-start=\"3368\" data-end=\"3431\"><strong data-start=\"3368\" data-end=\"3429\">une d\u00e9finition claire des param\u00e8tres critiques du proc\u00e9d\u00e9<\/strong><\/p>\r\n<\/li>\r\n \t<li data-start=\"3432\" data-end=\"3507\">\r\n<p data-start=\"3434\" data-end=\"3507\"><strong data-start=\"3434\" data-end=\"3505\">la r\u00e9p\u00e9tabilit\u00e9 du cycle dans toutes les conditions op\u00e9rationnelles<\/strong><\/p>\r\n<\/li>\r\n \t<li data-start=\"3508\" data-end=\"3552\">\r\n<p data-start=\"3510\" data-end=\"3552\"><strong data-start=\"3510\" data-end=\"3550\">une tra\u00e7abilit\u00e9 compl\u00e8te des donn\u00e9es<\/strong><\/p>\r\n<\/li>\r\n \t<li data-start=\"3553\" data-end=\"3623\">\r\n<p data-start=\"3555\" data-end=\"3623\"><strong data-start=\"3555\" data-end=\"3623\">l\u2019int\u00e9gration avec les syst\u00e8mes qualit\u00e9 et de validation du site<\/strong><\/p>\r\n<\/li>\r\n<\/ul>\r\n<p style=\"text-align: left\" data-start=\"3625\" data-end=\"3871\">Les solutions De Lama sont con\u00e7ues pour <strong data-start=\"3665\" data-end=\"3701\">faciliter la Cleaning Validation<\/strong>, gr\u00e2ce \u00e0 des <strong data-start=\"3715\" data-end=\"3746\">cycles hautement r\u00e9p\u00e9tables<\/strong>, des logiciels avanc\u00e9s, une gestion rigoureuse des param\u00e8tres critiques et une <strong data-start=\"3826\" data-end=\"3870\">documentation conforme aux exigences GMP<\/strong>.<\/p>\r\n\r\n\r\n<hr data-start=\"3873\" data-end=\"3876\" \/>\r\n\r\n<h2 style=\"text-align: left\" data-start=\"3878\" data-end=\"3925\"><strong data-start=\"3881\" data-end=\"3925\">Avantages des syst\u00e8mes de lavage De Lama<\/strong><\/h2>\r\n<p style=\"text-align: left\" data-start=\"3927\" data-end=\"4036\">Les syst\u00e8mes de lavage pharmaceutique De Lama offrent de nombreux avantages op\u00e9rationnels et r\u00e9glementaires :<\/p>\r\n\r\n<ul style=\"text-align: left\" data-start=\"4038\" data-end=\"4404\">\r\n \t<li data-start=\"4038\" data-end=\"4094\">\r\n<p data-start=\"4040\" data-end=\"4094\"><strong data-start=\"4040\" data-end=\"4092\">efficacit\u00e9 \u00e9lev\u00e9e d\u2019\u00e9limination des contaminants<\/strong><\/p>\r\n<\/li>\r\n \t<li data-start=\"4095\" data-end=\"4135\">\r\n<p data-start=\"4097\" data-end=\"4135\"><strong data-start=\"4097\" data-end=\"4133\">r\u00e9p\u00e9tabilit\u00e9 maximale du proc\u00e9d\u00e9<\/strong><\/p>\r\n<\/li>\r\n \t<li data-start=\"4136\" data-end=\"4188\">\r\n<p data-start=\"4138\" data-end=\"4188\"><strong data-start=\"4138\" data-end=\"4186\">r\u00e9duction du risque de contamination crois\u00e9e<\/strong><\/p>\r\n<\/li>\r\n \t<li data-start=\"4189\" data-end=\"4240\">\r\n<p data-start=\"4191\" data-end=\"4240\"><strong data-start=\"4191\" data-end=\"4238\">support complet pour la Cleaning Validation<\/strong><\/p>\r\n<\/li>\r\n \t<li data-start=\"4241\" data-end=\"4318\">\r\n<p data-start=\"4243\" data-end=\"4318\"><strong data-start=\"4243\" data-end=\"4316\">compatibilit\u00e9 avec des mat\u00e9riaux d\u00e9licats et des g\u00e9om\u00e9tries complexes<\/strong><\/p>\r\n<\/li>\r\n \t<li data-start=\"4319\" data-end=\"4404\">\r\n<p data-start=\"4321\" data-end=\"4404\"><strong data-start=\"4321\" data-end=\"4404\">int\u00e9gration avec des proc\u00e9d\u00e9s ult\u00e9rieurs de st\u00e9rilisation ou de d\u00e9contamination<\/strong><\/p>\r\n<\/li>\r\n<\/ul>\r\n<p style=\"text-align: left\" data-start=\"4406\" data-end=\"4541\">Chaque syst\u00e8me est <strong data-start=\"4425\" data-end=\"4445\">con\u00e7u sur mesure<\/strong>, en fonction des exigences sp\u00e9cifiques du client, du proc\u00e9d\u00e9 de production et de l\u2019application.<\/p>\r\n\r\n\r\n<hr data-start=\"4543\" data-end=\"4546\" \/>\r\n\r\n<h2 style=\"text-align: left\" data-start=\"4548\" data-end=\"4592\"><strong data-start=\"4551\" data-end=\"4592\">Applications du lavage pharmaceutique<\/strong><\/h2>\r\n<p style=\"text-align: left\" data-start=\"4594\" data-end=\"4678\">Les syst\u00e8mes de lavage De Lama trouvent leur application dans de nombreux domaines :<\/p>\r\n\r\n<ul style=\"text-align: left\" data-start=\"4680\" data-end=\"4903\">\r\n \t<li data-start=\"4680\" data-end=\"4825\">\r\n<p data-start=\"4682\" data-end=\"4825\"><strong data-start=\"4682\" data-end=\"4733\">industries pharmaceutiques et biotechnologiques<\/strong>, incluant la production <strong data-start=\"4758\" data-end=\"4774\">solide orale<\/strong> ainsi que la production <strong data-start=\"4799\" data-end=\"4823\">st\u00e9rile et aseptique<\/strong><\/p>\r\n<\/li>\r\n \t<li data-start=\"4826\" data-end=\"4854\">\r\n<p data-start=\"4828\" data-end=\"4854\"><strong data-start=\"4828\" data-end=\"4852\">dispositifs m\u00e9dicaux<\/strong><\/p>\r\n<\/li>\r\n \t<li data-start=\"4855\" data-end=\"4903\">\r\n<p data-start=\"4857\" data-end=\"4903\"><strong data-start=\"4857\" data-end=\"4903\">laboratoires de recherche et d\u00e9veloppement<\/strong><\/p>\r\n<\/li>\r\n<\/ul>\r\n<p style=\"text-align: left\" data-start=\"4905\" data-end=\"5056\">Ils peuvent \u00eatre utilis\u00e9s pour le traitement de <strong data-start=\"4953\" data-end=\"5055\">composants de proc\u00e9d\u00e9, accessoires de production, parties de ligne, contenants, outils et chariots<\/strong>.<\/p>\r\n\r\n\r\n<hr data-start=\"5058\" data-end=\"5061\" \/>\r\n\r\n<h2 style=\"text-align: left\" data-start=\"5063\" data-end=\"5137\"><strong data-start=\"5066\" data-end=\"5137\">L\u2019exp\u00e9rience de De Lama dans le lavage industriel et pharmaceutique<\/strong><\/h2>\r\n<p style=\"text-align: left\" data-start=\"5139\" data-end=\"5568\">Depuis plus de <strong data-start=\"5154\" data-end=\"5164\">75 ans<\/strong>, De Lama d\u00e9veloppe des technologies avanc\u00e9es pour le <strong data-start=\"5218\" data-end=\"5268\">lavage, la st\u00e9rilisation et la d\u00e9contamination<\/strong> destin\u00e9es aux industries les plus r\u00e9glement\u00e9es. L\u2019exp\u00e9rience acquise sur le terrain, associ\u00e9e \u00e0 un investissement continu en <strong data-start=\"5394\" data-end=\"5424\">recherche et d\u00e9veloppement<\/strong>, permet \u00e0 De Lama de proposer des <strong data-start=\"5459\" data-end=\"5567\">solutions fiables, valid\u00e9es et pr\u00eates \u00e0 relever les d\u00e9fis des nouvelles exigences de Cleaning Validation<\/strong>.<\/p>\r\n[\/read]","link":"https:\/\/www.delama.it\/fr\/categorie-produit\/laveuses-industrie-pharmaceutique-et-laboratoires-cgmp\/","name":"Machines \u00e0 laver pour Pharma et Labo","slug":"laveuses-industrie-pharmaceutique-et-laboratoires-cgmp","taxonomy":"product_category","parent":0,"meta":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MACHINES \u00e0 LAVER industrielles - Pharma - Labo - Cosm\u00e9tique<\/title>\n<meta name=\"description\" content=\"Vaste gamme de syst\u00e8mes de lavage conformes BPF. 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