{"id":15703,"date":"2026-11-05T18:01:28","date_gmt":"2026-11-05T17:01:28","guid":{"rendered":"https:\/\/www.s-vt.net\/?page_id=15703"},"modified":"2026-11-05T18:01:28","modified_gmt":"2026-11-05T17:01:28","slug":"eye-drops","status":"publish","type":"page","link":"https:\/\/www.s-vt.net\/ro\/eye-drops\/","title":{"rendered":"Pic\u0103turi oftalmice"},"content":{"rendered":"<div style='' class=''><section class='page-content' style=''  ><section class='container'><div style='' class=''><div class='row' style=''><div style='' class=''><div class='col-md-12 ' style=''><div style='' class=''><div class='cma-wysiwyg-editor'><p class=\"svt-lead2\">Medicamentele sub form\u0103 de pic\u0103turi oftalmice se aplic\u0103 la nivelul ochiului. Ca preparate pe baz\u0103 uleioas\u0103 sau apoas\u0103, ele permit ac\u021biunea local\u0103 a substan\u021belor medicamentoase con\u021binute.<\/p><div class=\"svt-ptiles\"><div class=\"svt-ptile\"><i class=\"fa fa-shield\" aria-hidden=\"true\"><\/i><strong>Fabricare steril\u0103<\/strong><span>Instala\u021bii rezistente la presiune \u0219i vid pentru produc\u021bie steril\u0103 conform\u0103 GMP.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-tint\" aria-hidden=\"true\"><\/i><strong>pH aproape de 7,4<\/strong><span>Bine tolerat de ochi, cu stabilitate optim\u0103 a substan\u021belor active.<\/span><\/div><div class=\"svt-ptile\"><i class=\"fa fa-tachometer\" aria-hidden=\"true\"><\/i><strong>Monitorizarea procesului<\/strong><span>Puncte de m\u0103surare pentru pH, presiune, temperatur\u0103 \u0219i debit.<\/span><\/div><\/div><h2>Fabricarea steril\u0103 ca premis\u0103 de baz\u0103<\/h2><p>La produc\u021bia de pic\u0103turi oftalmice trebuie respectate numeroase prevederi, iar fabricarea steril\u0103 este o premis\u0103 de baz\u0103. Prin urmare, instala\u021biile de amestecare trebuie concepute pentru o fabricare steril\u0103, rezistent\u0103 la presiune \u0219i vid. Doar astfel este posibil\u0103 produc\u021bia industrial\u0103 de pic\u0103turi oftalmice \u0219i de alte <a href=\"\/ro\/pharmaceuticals\/\">produse farmaceutice<\/a> conform GMP.<\/p><h2>pH-ul \u0219i stabilitatea substan\u021belor active<\/h2><p>Pentru a preveni irita\u021biile ochiului, pic\u0103turile oftalmice ar trebui s\u0103 aib\u0103 un pH c\u00e2t mai apropiat de valoarea fiziologic\u0103 de 7,4. La acest pH, majoritatea <a href=\"\/ro\/active-ingredients\/\">substan\u021belor active<\/a> sunt \u00eens\u0103 instabile din punct de vedere chimic.<\/p><p>Fabricarea trebuie, a\u0219adar, s\u0103 asigure o stabilitate optim\u0103 a substan\u021belor active, f\u0103r\u0103 a afecta pH-ul sau presiunea osmotic\u0103 a medicamentului. Pentru aceasta, instala\u021bia de proces ar trebui s\u0103 ofere urm\u0103toarele dot\u0103ri:<\/p><ul class=\"svt-checks\"><li>posibilit\u0103\u021bi de montare \u00een camera omogenizatorului pentru monitorizarea pH-ului, presiunii, temperaturii \u0219i debitului<\/li><li>alte puncte de m\u0103surare, de exemplu pentru pH \u00een conducta de recirculare<\/li><\/ul><h2>Cur\u0103\u021bare \u0219i sterilizare<\/h2><p>Sistemul de <a href=\"\/cip-sip-systeme\/\">cur\u0103\u021bare (CIP)<\/a> este de regul\u0103 fixat pe capac \u0219i\/sau pe agitator. Trebuie s\u0103 permit\u0103 o cur\u0103\u021bare f\u0103r\u0103 volume moarte, simpl\u0103 \u0219i rapid\u0103. De asemenea, sterilizarea instala\u021biei (SIP) este premisa de baz\u0103 pentru sterilitate absolut\u0103 \u00een rezervoare, conducte \u0219i ventile.<\/p><h2>\u00centreb\u0103ri frecvente despre fabricarea pic\u0103turilor oftalmice<\/h2><h3>Care este premisa de baz\u0103 la fabricarea pic\u0103turilor oftalmice?<\/h3><p>O fabricare steril\u0103. Instala\u021biile de amestecare trebuie, prin urmare, concepute rezistent la presiune \u0219i vid pentru fabricarea steril\u0103 conform GMP, inclusiv cur\u0103\u021bare CIP \u0219i sterilizare SIP.<\/p><h3>Ce pH ar trebui s\u0103 aib\u0103 pic\u0103turile oftalmice?<\/h3><p>C\u00e2t mai aproape de pH-ul fiziologic de 7,4, pentru a evita irita\u021biile. Deoarece multe substan\u021be active sunt instabile la acest pH, fabricarea trebuie s\u0103 asigure stabilitatea f\u0103r\u0103 a afecta pH-ul \u0219i presiunea osmotic\u0103.<\/p><h3>De ce tehnic\u0103 de m\u0103surare are nevoie instala\u021bia?<\/h3><p>Posibilit\u0103\u021bi de montare pentru monitorizarea pH-ului, presiunii, temperaturii \u0219i debitului, de exemplu \u00een camera omogenizatorului sau \u00een conducta de recirculare.<\/p><h3>Cum se cur\u0103\u021b\u0103 instala\u021biile?<\/h3><p>Printr-un sistem CIP pe capac \u0219i\/sau pe agitator, care cur\u0103\u021b\u0103 f\u0103r\u0103 volume moarte \u0219i economise\u0219te timp de proces, precum \u0219i printr-o sterilizare SIP pentru sterilitate absolut\u0103 a rezervoarelor, conductelor \u0219i ventilelor.<\/p><script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Service\",\"name\":\"Tehnologia proceselor pentru produc\u021bia de pic\u0103turi oftalmice\",\"description\":\"Consultan\u021b\u0103 privind instala\u021bii de proces sterile, rezistente la presiune \u0219i vid, pentru pic\u0103turi oftalmice, cu monitorizarea pH-ului, CIP \u0219i SIP conform GMP.\",\"url\":\"https:\/\/www.s-vt.net\/ro\/eye-drops\/\",\"provider\":{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.s-vt.net\/#seefried\",\"name\":\"SEEFRIED Verfahrenstechnik GmbH\",\"url\":\"https:\/\/www.s-vt.net\/\",\"telephone\":\"+49 4203 789492\"},\"areaServed\":\"Worldwide\"},{\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Care este premisa de baz\u0103 la fabricarea pic\u0103turilor oftalmice?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"O fabricare steril\u0103. 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