{"id":3442,"date":"2023-10-19T10:05:10","date_gmt":"2023-10-19T10:05:10","guid":{"rendered":"https:\/\/waterforinjection.com\/che-cosa-e-lacqua-per-iniettabili-wfi-e-acque-compendiali-secondo-le-farmacopee"},"modified":"2026-05-07T08:33:24","modified_gmt":"2026-05-07T08:33:24","slug":"che-cosa-e-lacqua-per-iniettabili-wfi-e-acque-compendiali-secondo-le-farmacopee","status":"publish","type":"page","link":"https:\/\/waterforinjection.com\/it\/che-cosa-e-lacqua-per-iniettabili-wfi-e-acque-compendiali-secondo-le-farmacopee","title":{"rendered":"CHE COSA E&#8217; L&#8217;ACQUA PER INIETTABILI? WFI E ACQUE COMPENDIALI SECONDO LE FARMACOPEE"},"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_bottom_divider\"><span class=\"et-pb-background-video\"><video autoplay loop playsinline muted><source type=\"video\/mp4\" src=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/04\/Bram-Cor-pharmaceutical-technologies-3-40001-0900.mov\" \/><\/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\">COSA E' L'ACQUA PER INIETTABILI?<\/h1><\/div><\/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>TIPI DI ACQUA E FARMACOPEE <\/h2>\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_1_2 et_block_column et_pb_css_mix_blend_mode_passthrough\">\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\"><h4>Le acque farmaceutiche<\/h4>\n<\/div><\/div>\n\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\"><p style=\"text-align: justify;\"><span style=\"font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;\">Solo alcuni tipi di acqua farmaceutica hanno la designazione USP e sono oggetto di monografie ufficiali nell'attuale farmacopea US. Tuttavia, lo stesso documento afferma che <em>\"sebbene non esistano standard microbici assoluti per l'acqua (diverso \u00e8 per quella destinata a diventare sterile), le norme cGMP richiedono che siano stabiliti e monitorati parametri appropriati\".<\/em> \"(...) <strong>i.e. l'acqua utilizzata per la formulazione di un prodotto non deve contenere organismi in grado di crescere nel prodotto. <\/strong>(...)\". <\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;\">Per questo, in Bram-Cor, ogni sistema di trattamento dell\u2019acqua \u00e8 realmente personalizzato e orientato ad uno specifico impianto farmaceutico, una linea ed un prodotto.<br \/>Il documento ISPE (ISPE BASELINE\u00a9 GUIDE, Water and steam Systems) spiega quale acqua pu\u00f2 essere utilizzata nello sviluppo, nella fabbricazione e nella preparazione di prodotti farmaceutici.<br \/>Queste acque rientrano in due categorie: <\/span><span style=\"font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;\"><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;\"><\/span><\/p>\n<h6><span style=\"color: #000000; font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;\">1. ACQUE COMPENDIALI<\/span><\/h6>\n<h6><span style=\"color: #000000; font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;\">2. ACQUE NON COMPENDIALI<\/span><\/h6>\n<\/div><\/div>\n<\/div>\n\n<div class=\"et_pb_column_3 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_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><span style=\"font-size: 14px;\"><\/span><\/p>\n<p><div id=\"attachment_353\" style=\"width: 1034px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-353\" class=\"wp-image-353 size-large\" src=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2020\/12\/L-Surgical-room-IV-bags-952-1024x474.jpg\" alt=\"{%ALT_TEXT%}\" width=\"1024\" height=\"474\" style=\"font-size: 14px;\" srcset=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2020\/12\/L-Surgical-room-IV-bags-952-1024x474.jpg 1024w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2020\/12\/L-Surgical-room-IV-bags-952-300x139.jpg 300w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2020\/12\/L-Surgical-room-IV-bags-952-768x356.jpg 768w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2020\/12\/L-Surgical-room-IV-bags-952-640x296.jpg 640w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2020\/12\/L-Surgical-room-IV-bags-952.jpg 1140w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><p id=\"caption-attachment-353\" class=\"wp-caption-text\"><span style=\"font-size: 14px;\"><span style=\"font-size: 14px;\"> IV (infusion) bags and bottles hanging on poles during a real surgery<\/p><\/div><\/span><\/span><\/p>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_row_3 et_pb_row et_block_row\">\n<div class=\"et_pb_column_4 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_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\"><h4>Cosa significano i termini \"acqua per iniettabili\" e \"acqua pruficata\" per l'industria farmaceutica <\/h4>\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\"><p>L'acqua viene impiegata come ingrediente e solvente in numerosi processi, formulazioni e prodotti. Pertanto, le farmacopee internazionali (USP, Ph.Eur., JP) definiscono come \u201cAcqua per preparazioni iniettabili\u201d (WFI) solo l'acqua compendiale utilizzata come eccipiente nelle soluzioni per uso parenterale. Il Glossario ISPE distingue quindi:<\/p>\n<p>- Acqua per iniettabili sfusa: \u201cAcqua per la preparazione di medicinali per somministrazione parenterale quando l'acqua \u00e8 utilizzata come veicolo\u201d;<\/p>\n<p>- Acqua sterilizzata per iniettabili: \u201cAcqua per sciogliere o diluire sostanze o preparati per somministrazione parenterale prima dell'uso\u201d.<\/p>\n<p><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\">\n<table id=\"tablepress-2\" class=\"tablepress tablepress-id-2\">\n<thead>\n<tr class=\"row-1\">\n\t<th class=\"column-1\"><strong>Non-sterile medicinal products<\/strong><\/th><th class=\"column-2\"><strong>Minimum acceptable quality of water<\/strong>*<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-2\">\n\t<td class=\"column-1\">Vaccines for non-parenteral use<\/td><td class=\"column-2\">(PW) Purified Water*<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Oral Preparations<\/td><td class=\"column-2\">(PW) Purified Water<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">Nebuliser Solutions<\/td><td class=\"column-2\">(PW) Purified Water**<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">Cutaneous Preparations<\/td><td class=\"column-2\">(PW) Purified Water***<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-1\">Nasal\/Ear Preparations<\/td><td class=\"column-2\">(PW) Purified Water<\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td class=\"column-1\">Rectal\/Vaginal Preparations<\/td><td class=\"column-2\">(PW) Purified Water<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-2 from cache --><\/span><\/p>\n<p><em>Fonte: EMA\/CHMP\/CVMP\/QWP\/496873\/2018. Pubblicazione: 13 novembre 2018. Si noti che l'acqua trattata soddisfa tutti i requisiti chimici previsti per la PW (acqua purificata). Inoltre, con un parametro aggiuntivo relativo alle endotossine batteriche, l'acqua soddisfa le specifiche caratteristiche della WFI. Poich\u00e9 i microrganismi che tendono a diffondersi nell'acqua producono endotossine, le attrezzature e le procedure utilizzate dalle linee di produzione per purificare, conservare e distribuire la WFI devono impedire l'accumulo di endotossine e ridurre al minimo la contaminazione microbica nel sistema.<\/em><\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\">\n<table id=\"tablepress-1\" class=\"tablepress tablepress-id-1\">\n<thead>\n<tr class=\"row-1\">\n\t<th class=\"column-1\"><strong>Sterile Medicinal Products<\/strong><\/th><th class=\"column-2\"><strong>Minimum acceptable quality of water<\/strong>*<\/th>\n<\/tr>\n<\/thead>\n<tbody class=\"row-striping row-hover\">\n<tr class=\"row-2\">\n\t<td class=\"column-1\">Biologics (including vaccines and ATMP)<\/td><td class=\"column-2\">(WFI) Water for Injection<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Parenteral<\/td><td class=\"column-2\">(WFI) Water for Injection<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">Ophthalmic (excluding ATMP)<\/td><td class=\"column-2\">(PW) Purified Water<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">Haemofiltration Solutions \/ Haemodiafiltration Solutions<\/td><td class=\"column-2\">(WFI) Water for Injection<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-1\">Peritoneal Dialysis Solutions<\/td><td class=\"column-2\">(WFI) Water for Injection<\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td class=\"column-1\">Irrigation Solutions<\/td><td class=\"column-2\">(WFI) Water for Injection<\/td>\n<\/tr>\n<tr class=\"row-8\">\n\t<td class=\"column-1\">Nasal\/Ear Preparations<\/td><td class=\"column-2\">(PW) Purified Water<\/td>\n<\/tr>\n<tr class=\"row-9\">\n\t<td class=\"column-1\">Cutaneous Preparations<\/td><td class=\"column-2\">(PW) Purified Water<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<!-- #tablepress-1 from cache --><\/span><span style=\"font-size: 12pt;\"><em><\/em><\/span><\/p>\n<p style=\"text-align: left;\"><em>Fonte: EMA\/CHMP\/CVMP\/QWP\/496873\/2018. Pubblicazione: 13 novembre 2018. *Si noti che l\u2019uso di acqua per preparazioni farmaceutiche (WFI) \u00e8 comunque raccomandato al fine di garantire la sicurezza dei vaccini e la qualit\u00e0 del prodotto. ** In determinate condizioni patologiche, i medicinali devono essere sterili e apirogeni. In tali casi, \u00e8 necessario utilizzare acqua per preparazioni farmaceutiche (WFI). ***Per alcuni prodotti, come i disinfettanti per capezzoli veterinari, pu\u00f2 essere accettabile l\u2019uso di acqua potabile, ove giustificato e autorizzato.<\/em><\/p>\n<\/div><\/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_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_heading_1 et_pb_heading et_pb_module et_block_module\"><div class=\"et_pb_heading_container\"><h2 class=\"et_pb_module_header\">A. ACQUA COMPENDIALE FARMACEUTICA<\/h2><\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_row_5 et_pb_row et_block_row\">\n<div class=\"et_pb_column_6 et_pb_column et_pb_column_1_2 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\"><div>\n<p>Le acque compendiali soddisfano i requisiti delle farmacopee USP, EPh.Eur. e JP, ma secondo la FDA, il documento ISPE sottolinea che:\u00a0 <em>\"(...) le specifiche delineate nelle monografie sono i requisiti minimi per l'acqua per iniettabili e per le acque compendiali. Ulteriori specifiche possono essere aggiunte o combinate in base ai requisiti del processo\".<\/em><\/p>\n<p>\u00a0<\/p>\n<\/div>\n<div>\n<p>Gli esempi di acque compendiali secondo ISPE sono:<\/p>\n<h4><span style=\"color: #000000; font-size: 16pt; font-family: tahoma, arial, helvetica, sans-serif;\">1. Acqua Purificata (PW), come viene classifcata dalle monografie USP \/ Ph.Eur.\u00a0<\/span><\/h4>\n<p style=\"text-align: justify;\">L'acqua purificata \u00e8 classificata per uso farmaceutico come eccipiente nella produzione di preparati non parenterali e, in particolare, per preparati\/test farmaceutici, per i quali \u00e8 indicata l'acqua, salvo diverse specifiche (vedere la farmacopea USP, Ph.Eur. e JP per riferimento).<\/p>\n<p>Pertanto, l'acqua potabile \u00e8 la fonte minima di acqua di alimentazione per produrre PW, attraverso deionizzazione, distillazione, scambio ionico, osmosi inversa, filtrazione o altre procedure appropriate. La PW \u00e8 anche una materia prima nella preparazione di WFI e vapore puro.<\/p>\n<p style=\"text-align: justify;\"><span style=\"font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;\"><\/span><\/p>\n<\/div>\n<div><\/div>\n<div>\n<div id=\"attachment_380\" style=\"width: 1034px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-380\" class=\"size-large wp-image-380\" src=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2020\/12\/LL-Bram-Cor-Water-Treatment-Room-IMG_5080-m1140-1-1024x474.jpg\" alt=\"{%ALT_TEXT%}\" width=\"1024\" height=\"474\" srcset=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2020\/12\/LL-Bram-Cor-Water-Treatment-Room-IMG_5080-m1140-1-1024x474.jpg 1024w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2020\/12\/LL-Bram-Cor-Water-Treatment-Room-IMG_5080-m1140-1-300x139.jpg 300w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2020\/12\/LL-Bram-Cor-Water-Treatment-Room-IMG_5080-m1140-1-768x356.jpg 768w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2020\/12\/LL-Bram-Cor-Water-Treatment-Room-IMG_5080-m1140-1-640x296.jpg 640w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2020\/12\/LL-Bram-Cor-Water-Treatment-Room-IMG_5080-m1140-1.jpg 1140w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><p id=\"caption-attachment-380\" class=\"wp-caption-text\">Sistema di Osmosi Inversa Bram-Cor Reverse in una sala di trattamento acqua, con un serbatoio di stoccaggio per with PW e Loop PW<\/p><\/div>\n<\/div>\n<p><span style=\"font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;\"><strong><\/strong><\/span><\/p>\n<p>L'<strong>acqua purificata sterile<\/strong>, come definita dall'USP, \u00e8 confezionata in PW e resa sterile; viene utilizzata nelle applicazioni che richiedono acqua purificata, dove l'accesso a un sistema di acqua purificata convalidato non \u00e8 utilizzabile (piccola q.t\u00e0 necessaria, per esempio).<\/p>\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"height: 221px;\">\n<tbody>\n<tr style=\"height: 77px;\">\n<td valign=\"top\" style=\"height: 77px; width: 216.521px;\">\n<h5>ACQUA PURIFICATA IN BULK<\/h5>\n<\/td>\n<\/tr>\n<tr style=\"height: 18px;\">\n<td valign=\"middle\" style=\"height: 18px; width: 216.521px;\">FISICI \/ CHIMICI<\/td>\n<td valign=\"middle\" style=\"height: 18px; width: 140.281px;\">Ph. Eur.<\/td>\n<td valign=\"middle\" style=\"height: 18px; width: 101.062px;\">USP<\/td>\n<\/tr>\n<tr style=\"height: 18px;\">\n<td valign=\"top\" style=\"height: 18px; width: 216.521px;\"><b><i>Apparenza<\/i><\/b><\/td>\n<td valign=\"top\" style=\"height: 18px; width: 140.281px;\"><strong>Senza colore, trasparente<\/strong><\/td>\n<td valign=\"top\" style=\"height: 18px; width: 101.062px;\"><b>Non definito<\/b><\/td>\n<\/tr>\n<tr style=\"height: 18px;\">\n<td valign=\"top\" style=\"height: 18px; width: 216.521px;\"><b><i>Conduttivit\u00e0<\/i><\/b><\/td>\n<td valign=\"top\" style=\"height: 18px; width: 140.281px;\"><b>\u2264 4.3 \u03bcS\/cm@20\u00b0C<\/b><\/td>\n<td valign=\"top\" style=\"height: 18px; width: 101.062px;\"><b>\u2264 1.3 \u03bcS\/cm@25\u00b0C<\/b><\/td>\n<\/tr>\n<tr style=\"height: 18px;\">\n<td valign=\"top\" style=\"height: 18px; width: 216.521px;\"><b><i>TOC<\/i><\/b><\/td>\n<td valign=\"top\" style=\"height: 18px; width: 140.281px;\"><b>\u2264<span class=\"Apple-converted-space\"> <\/span>0.5 mg\/l<\/b><\/td>\n<td valign=\"top\" style=\"height: 18px; width: 101.062px;\"><b>\u2264<span class=\"Apple-converted-space\"> <\/span>0.50 mg\/L<\/b><\/td>\n<\/tr>\n<tr style=\"height: 18px;\">\n<td valign=\"top\" style=\"height: 18px; width: 216.521px;\"><b><i>Nitrati NO\u2083<\/i><\/b><\/td>\n<td valign=\"top\" style=\"height: 18px; width: 140.281px;\"><b>\u2264 0.2 ppm<\/b><\/td>\n<td valign=\"top\" style=\"height: 18px; width: 101.062px;\"><b>Not defined<\/b><\/td>\n<\/tr>\n<tr style=\"height: 18px;\">\n<td valign=\"top\" style=\"height: 18px; width: 216.521px;\">MICROBIOLOGICI<\/td>\n<td valign=\"middle\" style=\"height: 18px; width: 140.281px;\">Ph. Eur.<\/td>\n<td valign=\"middle\" style=\"height: 18px; width: 101.062px;\">USP<\/td>\n<\/tr>\n<tr style=\"height: 18px;\">\n<td valign=\"top\" style=\"height: 18px; width: 216.521px;\"><b><i>Conta Batterica<\/i><\/b><\/td>\n<td valign=\"top\" style=\"height: 18px; width: 140.281px;\"><b>\u2264 100 CFU\/ml<\/b><\/td>\n<td valign=\"top\" style=\"height: 18px; width: 101.062px;\"><b>\u2264 100 CFU\/ml<\/b><\/td>\n<\/tr>\n<tr style=\"height: 18px;\">\n<td valign=\"top\" style=\"height: 18px; width: 216.521px;\"><b><i>Endotossine Batteriche<\/i><\/b><\/td>\n<td valign=\"top\" style=\"height: 18px; width: 140.281px;\"><b>&lt; 0.25 IU\/ml<\/b><\/td>\n<td valign=\"top\" style=\"height: 18px; width: 101.062px;\"><b>-<\/b><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>*I dati possono subire modifiche senza preavviso<\/p>\n<\/div><\/div>\n<\/div>\n\n<div class=\"et_pb_column_7 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_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\"><h4><span style=\"color: #000000; font-family: tahoma, arial, helvetica, sans-serif; font-size: 16pt;\">2. Acqua per Iniettabili (WFI) come viene classificata dalle monografie USP \/ Ph.Eur.\u00a0<\/span><\/h4>\n<p>L'acqua per iniettabili \u00e8 classificata ai fini farmaceutici come eccipiente nella produzione di preparati parenterali e in altri preparati farmaceutici in cui il contenuto di endotossine deve essere verificato (vedi le relative farmacopee USP, EP e JP).<\/p>\n<p>Di conseguenza, l'acqua deionizzata (che pu\u00f2 essere pretrattata per la distillazione successiva o un processo appropriato) \u00e8 la fonte minima di acqua di alimentazione per produrre WFI.<br \/>Oltre alle specifiche PW, WFI aggiunge il test per le endotossine batteriche e soddisfa tutti i requisiti (ad eccezione dell'etichettatura) per l'acqua confezionata nota come \"Sterile Purified Water\" (vedi monografia USP).<\/p>\n<p><strong>Acqua sterile per iniettabili<\/strong>, secondo la definizione \u00c8 WFI imballata e sterilizzata; viene utilizzata in applicazioni che richiedono acqua per iniezione, dove l'accesso a un sistema WFI convalidato non \u00e8 utilizzabile (piccola quantit\u00e0 necessaria, per esempio).<\/p>\n<p><strong>Acqua batteriostatica per iniettabili<\/strong>, come definita dall'USP. \u00c8 WFI con aggiunta di uno o pi\u00f9 conservanti antimicrobici; viene utilizzata come diluente nella preparazione di soluzioni parenterali (soprattutto per prodotti multidose che consentono ritiri ripetuti).<\/p>\n<p>\u00a0<\/p>\n<table cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td valign=\"top\">\n<h5>ACQUA PER INIETTABILI IN BULK<\/h5>\n<\/td>\n<\/tr>\n<tr>\n<td valign=\"middle\">FISICI \/ CHIMICI<\/td>\n<td valign=\"middle\">Ph. Eur.<\/td>\n<td valign=\"middle\">USP<\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><b><i>Apparenza<\/i><\/b><\/td>\n<td valign=\"top\"><b>Colorless, clear<\/b><\/td>\n<td valign=\"top\"><b>Not defined<\/b><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><b><i>Conduttivit\u00e0<\/i><\/b><\/td>\n<td valign=\"top\"><b>\u2264 1.1<span class=\"Apple-converted-space\"> <\/span>\u03bcS\/cm@20\u00b0C<\/b><\/td>\n<td valign=\"top\"><b>\u2264 1.3 \u03bcS\/cm @25\u00b0C<\/b><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><b><i>TOC<\/i><\/b><\/td>\n<td valign=\"top\"><b><span class=\"Apple-converted-space\"> <\/span>\u2264 0.5 mg\/L<\/b><\/td>\n<td valign=\"top\"><b>\u2264<span class=\"Apple-converted-space\"> <\/span>0.50 mg\/L<\/b><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><b><i>Nitrati NO\u2083<\/i><\/b><\/td>\n<td valign=\"top\"><b>\u2264 0.2 ppm<\/b><\/td>\n<td valign=\"top\"><b>Not defined<\/b><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><b><i>Alluminio<\/i><\/b><\/td>\n<td valign=\"top\"><b>\u2264<span class=\"Apple-converted-space\"> <\/span>10 ppb<\/b><\/td>\n<td valign=\"top\"><b>Not defined<\/b><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\">MICROBIOLOGICI<\/td>\n<td valign=\"middle\">Ph. Eur.<\/td>\n<td valign=\"middle\">USP<\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><b><i>Conta Batterica<\/i><\/b><\/td>\n<td valign=\"top\"><b>\u2264 10 CFU\/100 ml<\/b><\/td>\n<td valign=\"top\"><b>\u2264 10 CFU\/100 ml<\/b><\/td>\n<\/tr>\n<tr>\n<td valign=\"top\"><b><i>Endotossine Batteriche<\/i><\/b><\/td>\n<td valign=\"top\"><b>&lt; 0.25 IU\/ml<\/b><\/td>\n<td valign=\"top\"><b>&lt; 0.25 EU\/ml<\/b><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h5><span style=\"font-size: 10pt;\">*I dati possono cambiare senza preavviso\u00a0<\/span><\/h5>\n<p>\u00a0<\/p>\n<div id=\"attachment_1393\" style=\"width: 1090px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-1393\" src=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/04\/Bram-Cor-STMC-PRTW_411-2-e1758714282496.jpg\" width=\"1080\" height=\"680\" alt=\"\" class=\"wp-image-1393 size-full\" srcset=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/04\/Bram-Cor-STMC-PRTW_411-2-e1758714282496.jpg 1080w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/04\/Bram-Cor-STMC-PRTW_411-2-e1758714282496-980x551.jpg 980w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/04\/Bram-Cor-STMC-PRTW_411-2-e1758714282496-480x270.jpg 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1080px, 100vw\" \/><p id=\"caption-attachment-1393\" class=\"wp-caption-text\">Un classico distillatore a vapore compresso BRAM-COR con un sistema di pretrattamento personalizzato sullo stesso skid.<\/p><\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n\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_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\"><h4><span style=\"color: #000000; font-size: 14pt; font-family: tahoma, arial, helvetica, sans-serif;\"><em>La distillazione \u00e8 il metodo principale per produrre WFI<\/em><\/span><\/h4>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\">Esistono due tecnologie di base che hanno segnato la storia dell'industria farmaceutica per la produzione di WFI: il sistema di distillazione a vapore compresso (VC), mediante alambicchi per la compressione del vapore, e il sistema di distillazione a multiplo effetto (ME), mediante alambicchi a pi\u00f9 stadi. <br \/><\/span><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\">Negli ultimi anni \u00e8 diventato possibile ottenere anche WFI a freddo, da <strong>osmosi inversa<\/strong>.<br \/>Ci\u00f2 \u00e8 dovuto alle nuove generazioni di membrane che consentono l'aggiunta di una successiva fase di ultrafiltrazione (UF).<br \/>Sotto, puoi vedere nel modello CROW di BRAM-COR (Generatore WFI per osmosi inversa addizionato di un sistema di ultrafiltrazione) la coppia di filtri UF posizionati a valle. <\/span><br \/><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\"><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\"><\/span><\/p>\n<div class=\"mceTemp\"><\/div>\n<\/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\/12\/BRAM-COR-CROW-SINP-EDI-UF-639-Producing-WFI-1440.webp\" width=\"1440\" height=\"788\" srcset=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/12\/BRAM-COR-CROW-SINP-EDI-UF-639-Producing-WFI-1440.webp 1440w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/12\/BRAM-COR-CROW-SINP-EDI-UF-639-Producing-WFI-1440-1280x700.webp 1280w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/12\/BRAM-COR-CROW-SINP-EDI-UF-639-Producing-WFI-1440-980x536.webp 980w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/12\/BRAM-COR-CROW-SINP-EDI-UF-639-Producing-WFI-1440-480x263.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) 1440px, 100vw\" class=\"wp-image-2766\" title=\"BRAM-COR CROW SINP EDI-UF 639- Producing WFI-1440\" \/><\/span><\/div>\n\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\"><h4><span style=\"font-size: 14pt; font-family: tahoma, arial, helvetica, sans-serif;\"><em><span style=\"color: #3366ff;\"><span style=\"color: #000000;\"><\/span><\/span><\/em><\/span><\/h4>\n<h4><span style=\"font-size: 14pt; font-family: tahoma, arial, helvetica, sans-serif;\"><em><span style=\"color: #3366ff;\"><span style=\"color: #000000;\">Produrre WFI - Note sulle Farmacopee<\/span><\/span><\/em><\/span><\/h4>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\">USP 27 (2004) ha rivisto la monografia USP WFI; essa ammette WFI da <em>\"Distillazione o un processo di purificazione che \u00e8 equivalente o superiore alla distillazione nella rimozione di sostanze chimiche e microrganismi\". <\/em>Nel 2008 l'EMEA (European Medicines Evaluation Agency, ora EMA) ha pubblicato un documento di riflessione per spiegare perch\u00e9 l'uso della tecnologia a membrana non era considerato accettabile per la produzione di WFI. <\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\">Dal 2010 l'EDQM (European Directorate for Quality of Medicines &amp; HealthCare) lavora a sondaggi per raccogliere dati industriali su \"Preparazione di WFI utilizzando l'osmosi inversa (RO)\". Nel 2011 l'EDQM (Expert Workshop) ha esaminato i potenziali usi dei sistemi a membrana per la produzione di WFI e, nel 2014, ha lavorato per consentire l'inclusione delle tecnologie non di distillazione nella EP, oltre alla distillazione per la produzione di WFI.<br \/>Negli ultimi anni, i documenti (EMA Q&amp;A EMA \/ INS \/ GMP \/ 489331 \/ 2016) e le questioni correlate vengono nuovamente esaminati.<br \/>Di conseguenza (pubblicazione EP 9.1), la monografia HPW (vedi sotto) verr\u00e0 eliminata.<\/span><\/p>\n<div class=\"mceTemp\"><\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_row_7 et_pb_row et_block_row\">\n<div class=\"et_pb_column_9 et_pb_column et_pb_column_1_2 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\"><h4><span style=\"color: #000000; font-size: 16pt; font-family: tahoma, arial, helvetica, sans-serif;\">3. HPW (Acqua altamente purificata), come viene classificata dalla monografia Ph.Eur <\/span><\/h4>\n<p><span style=\"font-size: 12pt;\"><em><strong>(fino al 2018; non pi\u00f9 classificata da Ph. Eur.) <\/strong><\/em><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt;\">HPW: Acqua altamente purificata (= acqua \u201cultra pura\u201d industriale) \u00e8 classificata dalla monografia precedente Ph.Eur. come eccipiente nella produzione di prodotti farmaceutici in cui le endotossine batteriche devono essere controllate, a meno che non sia specificato \u201cWFI\u201d. <\/span><\/p>\n<h4><span style=\"color: #000000; font-size: 16pt; font-family: tahoma, arial, helvetica, sans-serif;\">4. WFH (Acqua per Emodialisi), come viene classificata dalla monografia USP<\/span><\/h4>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\">L'acqua per l'emodialisi \u00e8 principalmente classificata in applicazioni farmaceutiche per l'emodialisi (vedi la relativa monografia USP), i.e. ad esempio nella diluizione di soluzioni concentrate. \u00c8 prodotta da acqua potabile dell'EPA (Agenzia per la protezione ambientale degli Stati Uniti), che \u00e8 stata ulteriormente purificata per ridurre i componenti chimici e microbiologici. Si noti che la WFH non \u00e8 destinata all'iniezione. <\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\"><\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\"><em>Nota: l'acqua purificata (PW) o l'acqua per preparazioni iniettabili (WFI) confezionate <strong style=\"font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;\">devono essere sterilizzate<\/strong> per preservarne le propriet\u00e0 microbiologiche; pertanto, esistono altre acque confezionate descritte nelle monografie, quali l'acqua purificata sterile, l'acqua sterile per preparazioni iniettabili, l'acqua batteriostatica per preparazioni iniettabili e cos\u00ec via (vedere le relative monografie dell'USP).<\/em><br \/><\/span><\/p>\n<p>\u00a0<\/p>\n<\/div><\/div>\n<\/div>\n\n<div class=\"et_pb_column_10 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_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\"><div id=\"attachment_2708\" style=\"width: 1288px\" class=\"wp-caption aligncenter\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-2708\" src=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/09\/IV-Fluids-production-with-Bram-Cor-BFIL-linear-filling-system-for-bags-1.webp\" width=\"1278\" height=\"837\" alt=\"IV Fluids production with Bram-Cor BFIL, linear filling system for bags\" class=\"wp-image-2708 size-full\" srcset=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/09\/IV-Fluids-production-with-Bram-Cor-BFIL-linear-filling-system-for-bags-1.webp 1278w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/09\/IV-Fluids-production-with-Bram-Cor-BFIL-linear-filling-system-for-bags-1-980x642.webp 980w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/09\/IV-Fluids-production-with-Bram-Cor-BFIL-linear-filling-system-for-bags-1-480x314.webp 480w\" sizes=\"(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) and (max-width: 980px) 980px, (min-width: 981px) 1278px, 100vw\" \/><p id=\"caption-attachment-2708\" class=\"wp-caption-text\">Produzione di fluidi per flebo (IV Fluids) con BFIL BRAM-COR, sistema lineare di riempimento per sacche.<\/p><\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n<div class=\"et_pb_row_8 et_pb_row et_block_row\">\n<div class=\"et_pb_column_11 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_2 et_pb_heading et_pb_module et_block_module\"><div class=\"et_pb_heading_container\"><h2 class=\"et_pb_module_header\">B. ACQUE NON COMPENDIALI <\/h2><\/div><\/div>\n\n<div class=\"et_pb_text_12 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-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\">Le acque non compendiali soddisfano almeno i requisiti di acqua potabile.<br \/>Si noti che le acque non compendiali non sono necessariamente di qualit\u00e0 inferiore rispetto alle acque compendiali. Tuttavia, i sistemi idrici non compendiali possono essere validati oppure no e, in generale, le acque non compendiali sono destinate ad avere la qualit\u00e0 adeguata richiesta dalla singola domanda. Per esempio: acqua potabile, acqua addolcita, acqua di ultra filtrazione, acqua di osmosi inversa, acqua EDI (processo di deionizzazione), acqua distillata.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/04\/drinking-water-Non-compendial-water-e1744375818856.webp\" width=\"1920\" height=\"698\" alt=\"\" class=\"wp-image-1394 aligncenter size-full\" srcset=\"https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/04\/drinking-water-Non-compendial-water-e1744375818856.webp 1920w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/04\/drinking-water-Non-compendial-water-e1744375818856-1280x698.webp 1280w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/04\/drinking-water-Non-compendial-water-e1744375818856-980x551.webp 980w, https:\/\/waterforinjection.com\/wp-content\/uploads\/2025\/04\/drinking-water-Non-compendial-water-e1744375818856-480x270.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\" \/><\/span><\/p>\n<p><span style=\"font-size: 12pt; font-family: tahoma, arial, helvetica, sans-serif;\">Sito sponsorizzato da <a href=\"https:\/\/www.bram-cor.com\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span style=\"color: #33cccc;\">BRAM-CO<\/span>R<\/a> Italia | waterforinjection.com <a href=\"\/?page_id=587\" target=\"_blank\" rel=\"noopener\">Cookie Policy<\/a><\/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_9 et_pb_row et_pb_gutters1 et_block_row\">\n<div class=\"et_pb_column_12 et_pb_column et_pb_column_2_3 et_block_column et_pb_css_mix_blend_mode_passthrough\">\n<div class=\"et_pb_text_13 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 &amp; 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=101\" 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_13 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_14 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; 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