{"id":3557,"date":"2023-09-24T13:58:14","date_gmt":"2023-09-24T13:58:14","guid":{"rendered":"https:\/\/waterforinjection.com\/produzione-di-acqua-per-iniettabili-mediante-osmosi-inversa-e-ultrafiltrazione"},"modified":"2026-10-13T15:42:18","modified_gmt":"2026-10-13T15:42:18","slug":"produzione-di-acqua-per-iniettabili-mediante-osmosi-inversa-e-ultrafiltrazione","status":"publish","type":"page","link":"https:\/\/waterforinjection.com\/it\/produzione-di-acqua-per-iniettabili-mediante-osmosi-inversa-e-ultrafiltrazione","title":{"rendered":"Produzione di acqua per iniettabili mediante osmosi inversa + ultrafiltrazione"},"content":{"rendered":"<div class=\"et_pb_section_0 et_pb_section et_section_regular et_block_section et-pb-has-background-video et_pb_preload section_has_divider et_pb_top_divider et_pb_bottom_divider\"><div class=\"et_pb_top_inside_divider et-no-transition\"><\/div><span class=\"et-pb-background-video\"><video autoplay loop playsinline muted><source type=\"video\/mp4\" data-src=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/04\/Bram-Cor-Worldwide.mp4\" \/><\/video><\/span>\n<div class=\"et_pb_row_0 et_pb_row et_block_row\">\n<div class=\"et_pb_column_0 et_pb_column et_pb_column_4_4 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_heading_0 et_pb_heading et_pb_module et_block_module\"><div class=\"et_pb_heading_container\"><h1 class=\"et_pb_module_header\">PRODUZIONE DI WFI MEDIANTE MEMBRANE CON TECNOLOGIA RO + UF<\/h1><\/div><\/div>\n\n<div class=\"et_pb_image_0 et_pb_image et_pb_module et_block_module\"><span class=\"et_pb_image_wrap\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/11\/BRAM-COR-CROW-SINP-EDI-UF-639-1929x1440-1-e1763387414140.webp\" width=\"1920\" height=\"1440\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) and (max-width: 1280px) 1280px, (min-width: 1281px) 1920px, 100vw\" class=\"wp-image-2736\" alt=\"CROW - Generatore di WFI Bram-Cor a membrana\" title=\"BRAM-COR CROW SINP EDI-UF 639-1929x1440\" \/><\/span><\/div>\n<\/div>\n<\/div>\n<div class=\"et_pb_bottom_inside_divider et-no-transition\"><\/div><\/div>\n\n<div class=\"et_pb_section_1 et_pb_section et_section_regular et_block_section\">\n<div class=\"et_pb_row_1 et_pb_row et_block_row\">\n<div class=\"et_pb_column_1 et_pb_column et_pb_column_4_4 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_0 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module preset--module--divi-text--default\"><div class=\"et_pb_text_inner\"><h2><span style=\"font-family: tahoma, arial, helvetica, sans-serif;\">Produrre WFI \"a freddo\" con sistemi di osmosi inversa basati sulle membrane<\/span><\/h2>\n<\/div><\/div>\n\n<div class=\"et_pb_text_1 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module preset--module--divi-text--default\"><div class=\"et_pb_text_inner\"><p><span style=\"font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;\"><span class=\"\">La produzione di WFI tramite osmosi inversa \u00e8 sicura? I requisiti per i sistemi WFI \u201ca freddo\u201d sono stati oggetto di molte discussioni negli ultimi anni. L\u2019ISPE (  <span>L\u2019International Society for Pharmaceutical Engineering ha pubblicato una <a href=\"https:\/\/ispe.org\/publications\/guidance-documents\/good-practice-guide-membrane-based-wfi-systems\">guida alle buone pratiche<\/a> sui sistemi a membrana per la produzione di WFI. In passato, la Farmacopea Europea (Ph.Eur.) consentiva l\u2019uso della distillazione solo per la produzione di WFI; la situazione \u00e8 cambiata nel 2017. Pertanto, ora \u00e8 consentito anche l\u2019uso della tecnologia a membrana come alternativa. Oltre a prestare sempre maggiore attenzione ai costi, le farmacopee di tutto il mondo si sono concentrate sugli attributi di qualit\u00e0 dell\u2019acqua per iniezione (WFI), consentendo cos\u00ec di prendere in considerazione tecnologie di produzione alternative volte a ridurre i costi di produzione. Tuttavia, l\u2019esperienza di Bram-Cor \u2014 cos\u00ec come le linee guida ISPE \u2014 consiglia di valutare non solo il costo dell\u2019investimento iniziale (CAPEX), ma anche i costi di manutenzione a lungo termine (OPEX). Questo va fatto tenendo conto anche dei rischi legati alla generazione e alla distribuzione del freddo, oltre che delle ulteriori criticit\u00e0 che si presentano se l\u2019acqua prodotta nel circuito viene successivamente riscaldata.       <\/span>BRAM-COR si impegna a fornire<\/span> a clear answer to every need of water treatment <span class=\"\">to produce <strong>pharmaceutical waters<\/strong> (i.e. PW or WFI)<\/span> <span class=\"\">or at least<\/span> <span class=\"\">critical applications<\/span> (cosmetics, healthcare, human <span class=\"\">food and animal feed<\/span>, <span class=\"\">(per esempio). Quindi, il nostro approccio \u00e8 davvero mirato e si basa su una vasta gamma di conoscenze specifiche, anche nei sistemi di osmosi inversa a membrana.   <\/span><\/span><\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_row_2 et_pb_row et_block_row\">\n<div class=\"et_pb_column_2 et_pb_column et_pb_column_4_4 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_2 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module preset--module--divi-text--default\"><div class=\"et_pb_text_inner\"><h3>WFI E ACQUE FARMACEUTICHE ATTRAVERSO L'OSMOSI INVERSA<\/h3>\n<\/div><\/div>\n\n<div class=\"et_pb_text_3 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module preset--module--divi-text--default\"><div class=\"et_pb_text_inner\"><p style=\"text-align: left;\"><span class=\"\" style=\"font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;\">Riteniamo che ogni stabilimento farmaceutico abbia bisogno di acqua \u00abpura\u00bb. Innanzitutto, ci si chiede: cosa si intende per \u00abpura\u00bb?  In order to answer this question, it is necessary to go back to the source and<span class=\"alt-edited\"> analyse <\/span> the quality of the water in-situ (the raw water used), which varies greatly from place to place. <span title=\"Il compito del pretrattamento dell'acqua \u00e8 proprio questo: portare l'acqua ad una qualit\u00e0 funzionale, relazionata ad uno specifico processo produttivo, secondo le user requirements specification.\">Quindi, il compito del pretrattamento dell\u2019acqua \u00e8 proprio questo: portare quella specifica acqua a una qualit\u00e0 funzionale, secondo le specifiche dei requisiti dell\u2019utente (URS). La natura dell\u2019acqua di alimentazione \u00e8 un fattore cruciale per determinare se sia vantaggioso o meno utilizzare l\u2019osmosi inversa per la produzione di WFI.<br \/>I sistemi di trattamento dell\u2019acqua Bram-Cor sono progettati su misura per garantire una qualit\u00e0 costante dell\u2019acqua WFI in tutto il mondo, sulla base di un\u2019analisi approfondita dell\u2019acqua di alimentazione locale \u2014 un fattore che influenza fortemente la scelta della tecnologia.   <\/span><\/span><\/p>\n<div><\/div>\n<\/div><\/div>\n\n<div class=\"et_pb_image_1 et_pb_image et_pb_module et_block_module\"><span class=\"et_pb_image_wrap\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/09\/CROW-SIN-EDI-UF-IMG_0634-1920-1.webp\" width=\"1920\" height=\"1508\" srcset=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/09\/CROW-SIN-EDI-UF-IMG_0634-1920-1.webp 1920w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/09\/CROW-SIN-EDI-UF-IMG_0634-1920-1-1280x1005.webp 1280w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/09\/CROW-SIN-EDI-UF-IMG_0634-1920-1-980x770.webp 980w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/09\/CROW-SIN-EDI-UF-IMG_0634-1920-1-480x377.webp 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) and (max-width: 1280px) 1280px, (min-width: 1281px) 1920px, 100vw\" class=\"wp-image-2691\" alt=\"Impianto-sanitario-a-osmosi-inversa\" title=\"CROW SIN EDI +UF-IMG_0634-1920\" \/><\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_section_2 et_pb_section et_section_regular et_block_section\">\n<div class=\"et_pb_row_3 et_pb_row et_block_row\">\n<div class=\"et_pb_column_3 et_pb_column et_pb_column_1_2 et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_4 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module preset--module--divi-text--default\"><div class=\"et_pb_text_inner\"><h3>La WFI fredda derivante dall\u2019osmosi inversa richiede l\u2019ultrafiltrazione<\/h3>\n<\/div><\/div>\n\n<div class=\"et_pb_text_5 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module preset--module--divi-text--default\"><div class=\"et_pb_text_inner\"><div><span style=\"font-size: 16px; font-family: tahoma, arial, helvetica, sans-serif;\">Nella produzione di WFI, il sistema di osmosi inversa (RO) richiede non solo un'unit\u00e0 di ultrafiltrazione (UF) come sistema di pretrattamento, ma anche un'adeguata unit\u00e0 UF a valle per prevenire le contaminazioni. Ovviamente, bisogna monitorare costantemente l\u2019efficienza dell\u2019osmosi inversa, per quanto riguarda il degrado delle membrane, la prevenzione del biofilm e la carica microbica, con sanificazioni periodiche. Se non ci sono ostacoli a garantire questo monitoraggio costante, <strong>il sistema di osmosi inversa pu\u00f2 offrire un vero vantaggio<\/strong>, riducendo il fabbisogno energetico e quindi i costi di produzione.  <\/span><\/div>\n<\/div><\/div>\n<\/div>\n\n<div class=\"et_pb_column_4 et_pb_column et_pb_column_1_2 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_6 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module preset--module--divi-text--default\"><div class=\"et_pb_text_inner\"><h3>Sistemi di osmosi inversa e di pretrattamento dell'acqua<\/h3>\n<\/div><\/div>\n\n<div class=\"et_pb_text_7 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module preset--module--divi-text--default\"><div class=\"et_pb_text_inner\"><p style=\"text-align: left;\"><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\">The raw water must be pre-treated to remove contaminants (such as particulates, calcium and magnesium salts, heavy metals, organics and bacteria) through a multiplicity of different steps (they can include softeners, UV reactors, deionizers, \u2026) <\/span><span style=\"font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;\">La luce ultravioletta viene impiegata come battericida e per decomporre i contaminanti organici.<br \/>La sorgente UV ha una lunghezza d'onda di 240-260 nm (UV-C) per ottenere una riduzione assoluta dei contaminanti patogeni tipici. <\/span><\/p>\n<div style=\"text-align: left;\"><\/div>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\">Le stazioni di dosaggio dei prodotti chimici vengono installate per diversi scopi, come la disinfezione dell\u2019acqua e\/o la neutralizzazione del cloro. La qualit\u00e0 dell\u2019acqua pretrattata viene monitorata costantemente per garantire che sia idonea ad alimentare gli impianti di trattamento a valle, come le unit\u00e0 di osmosi inversa (RO) per la produzione di acqua per uso farmaceutico (WFI).   <\/span><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\">Per una strategia efficace di controllo microbico volta a prevenire la formazione di biofilm e a contrastare gravi contaminazioni da <em>Pseudomonas aeruginosa<\/em>, BRAM-COR progetta e fornisce <strong>versioni sanificabili con acqua calda.<\/strong><\/span><\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_section_3 et_pb_section et_section_regular et_block_section\">\n<div class=\"et_pb_row_4 et_pb_row et_block_row\">\n<div class=\"et_pb_column_5 et_pb_column et_pb_column_4_4 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_8 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module preset--module--divi-text--default\"><div class=\"et_pb_text_inner\"><p><strong>Puoi allargare e\/o ruotare l'immagine 3D.<\/strong><\/p>\n<\/div><\/div>\n\n<div class=\"et_pb_code_0 et_pb_code et_pb_module\"><div class=\"et_pb_code_inner\">\n        <div class=\"modelViewerBlock\" data-attributes='{&quot;model&quot;:{&quot;modelUrl&quot;:&quot;https:\\\/\\\/waterforinjection.com\\\/wp-content\\\/uploads\\\/2025\\\/04\\\/CROS-SINP-EDI-UF_1.glb&quot;,&quot;poster&quot;:&quot;&quot;,&quot;skyboxImage&quot;:null,&quot;arEnabled&quot;:false,&quot;arMode&quot;:&quot;webxr scene-viewer quick-look&quot;,&quot;arPlacement&quot;:&quot;floor&quot;,&quot;modelISOSrc&quot;:null},&quot;align&quot;:&quot;center&quot;,&quot;uniqueId&quot;:&quot;model1027&quot;,&quot;currentViewer&quot;:&quot;modelViewer&quot;,&quot;O3DVSettings&quot;:{&quot;isFullscreen&quot;:true,&quot;camera&quot;:null,&quot;mouseControl&quot;:true,&quot;zoom&quot;:true},&quot;lazyLoad&quot;:false,&quot;loading&quot;:&quot;auto&quot;,&quot;zoom&quot;:true,&quot;preload&quot;:&quot;auto&quot;,&quot;mouseControl&quot;:true,&quot;fullscreen&quot;:true,&quot;zoomInOutBtn&quot;:false,&quot;cameraBtn&quot;:false,&quot;downloadBtn&quot;:false,&quot;loadingPercentage&quot;:false,&quot;progressBar&quot;:true,&quot;environmentImage&quot;:&quot;&quot;,&quot;exposure&quot;:&quot;1&quot;,&quot;shadow&quot;:1,&quot;woo&quot;:false,&quot;placement&quot;:&quot;shortcode&quot;,&quot;styles&quot;:{&quot;width&quot;:&quot;100%&quot;,&quot;height&quot;:&quot;1000px&quot;,&quot;bgColor&quot;:&quot;transparent&quot;}}'>\n            <div class=\"bp3d_backup_view\" style=\"display: none;height:350px;\">\n                <model-viewer camera-controls src=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/04\/CROS-SINP-EDI-UF_1.glb\" style=\"height: 350px;\"><\/model-viewer>\n            <\/div>\n        <\/div>\n\n        <\/div><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_section_4 et_pb_section et_section_regular et_block_section\">\n<div class=\"et_pb_row_5 et_pb_row et_pb_gutters1 et_block_row\">\n<div class=\"et_pb_column_6 et_pb_column et_pb_column_2_3 et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_9 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module preset--module--divi-text--default\"><div class=\"et_pb_text_inner\"><h3 style=\"text-align: right;\">USEFUL LINKS & SYSTEMS KNOWLEDGE<\/h3>\n<p style=\"text-align: right;\">Main site: <span style=\"color: #ccffcc;\"><strong><a href=\"https:\/\/www.bram-cor.com\/en\/en-home\" target=\"_blank\" rel=\"noopener\" style=\"color: #ccffcc;\">bram-cor.com<\/a><\/strong><\/span><\/p>\n<p style=\"text-align: right;\">To view <span style=\"color: #ccffcc;\"><strong><a href=\"\/?page_id=3549\" style=\"color: #ccffcc;\">Bram-Cor Equipment catalogue <\/a><\/strong><\/span> <\/p>\n<p style=\"text-align: right;\">To view where <span style=\"color: #ccffcc;\"><strong><a href=\"https:\/\/waterforinjection.com\/wfi-equipment-gmp-reference-standards\" style=\"color: #ccffcc;\">Bram-Cor Equipment works<\/a><\/strong><\/span><\/p>\n<p style=\"text-align: right;\">About pharmaceutical water treatment systems:<\/p>\n<p style=\"text-align: right;\"><span style=\"color: #ccffcc;\"><strong><a href=\"https:\/\/www.multiple-effect-water-distiller.com\" target=\"_blank\" rel=\"noopener\" style=\"color: #ccffcc;\">multiple-effect-water-distiller.com<\/a><\/strong><\/span><br \/><span style=\"color: #ccffcc;\"><strong><a href=\"https:\/\/www.vapor-compression-distiller.com\" target=\"_blank\" rel=\"noopener\" style=\"color: #ccffcc;\">vapor-compression-distiller.com<\/a><\/strong><\/span><br \/><span style=\"color: #ccffcc;\"><strong><a href=\"https:\/\/www.pharmaceutical-reverse-osmosis-systems.com\/\" target=\"_blank\" rel=\"noopener\" style=\"color: #ccffcc;\">pharmaceutical-reverse-osmosis-systems.com<\/a><\/strong><\/span><br \/><span style=\"color: #ccffcc;\"><strong><a href=\"https:\/\/www.pure-steam-generator.com\/\" target=\"_blank\" rel=\"noopener\" style=\"color: #ccffcc;\">pure-steam-generator.com<\/a><\/strong><\/span><\/p>\n<p style=\"text-align: right;\">About pharmaceutical process systems and turnkey plants:<\/p>\n<p style=\"text-align: right;\"><a href=\"https:\/\/www.bram-cor-pharmaprocessing.com\" target=\"_blank\" rel=\"noopener\"><strong><span style=\"color: #00ff00;\"><span style=\"color: #ccffcc;\">bram-cor-pharmaprocessing.com<\/span><\/span><\/strong><\/a><br \/><span style=\"color: #ccffcc;\"><strong><a href=\"https:\/\/www.ivfluids-parenteralsolutions.com\" target=\"_blank\" rel=\"noopener\" style=\"color: #ccffcc;\">ivfluids-parenteralsolutions.com<\/a><\/strong><\/span><br \/><span style=\"color: #ccffcc;\"><strong><a href=\"https:\/\/www.pharmaceutical-turnkey.com\" target=\"_blank\" rel=\"noopener\" style=\"color: #ccffcc;\">pharmaceutical-turnkey.com<\/a><\/strong><\/span><span style=\"color: #ccffcc;\"><strong><\/strong><\/span><\/p>\n<\/div><\/div>\n<\/div>\n\n<div class=\"et_pb_column_7 et_pb_column et_pb_column_1_3 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_10 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module preset--module--divi-text--default\"><div class=\"et_pb_text_inner\"><p style=\"text-align: right;\">Site sponsored by BRAM-COR SPA - Italy<\/p>\n<p style=\"text-align: right;\">waterforinjection.com <span style=\"text-decoration: underline;\"><span style=\"color: #ffffff; text-decoration: underline;\"><a 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data-src=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/04\/BRAM-COR-SITO-Footer-Water.mov\" \/><\/video><\/span><\/div>\n\n<div class=\"et_pb_section_6 et_pb_section et_section_regular et_block_section\">\n<div class=\"et_pb_row_6 et_pb_row et_block_row\">\n<div class=\"et_pb_column_8 et_pb_column et_pb_column_4_4 et-last-child et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_11 et_pb_text et_pb_bg_layout_light et_pb_module et_block_module preset--module--divi-text--default\"><div class=\"et_pb_text_inner\"><p>\u00a9 2025 BRAM-COR SPA - VIA MERCALLI 12\/A - 43122 PARMA - ITALY - <span>P.IVA 01699350342<\/span><\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":3555,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-3557","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Generazione di acqua per iniettabili tramite Osmosi Inversa + ultrafiltrazione<\/title>\n<meta name=\"description\" content=\"Produrre WFI dall&#039;osmosi inversa richiede un&#039;attenzione particolare, poich\u00e9 nella RO non c&#039;\u00e8 un cambiamento di stato dell&#039;acqua (naturale barriera microbiologica).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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