{"id":695,"date":"2024-07-15T12:18:52","date_gmt":"2024-07-15T10:18:52","guid":{"rendered":"https:\/\/www.qvalitek.com\/?page_id=695"},"modified":"2024-07-15T12:25:48","modified_gmt":"2024-07-15T10:25:48","slug":"radiopharmaceuticals-hot-cells-validation-services","status":"publish","type":"page","link":"https:\/\/www.qvalitek.com\/lt\/radiopharmaceuticals-hot-cells-validation-services\/","title":{"rendered":"Radiofarmacijos \"Hot Cells\" kvalifikavimas"},"content":{"rendered":"<div class=\"wp-block-cover\"><span aria-hidden=\"true\" class=\"wp-block-cover__background has-black-background-color has-background-dim\"><\/span><img data-dominant-color=\"837569\" data-has-transparency=\"false\" style=\"--dominant-color: #837569;\" decoding=\"async\" width=\"640\" height=\"480\" sizes=\"(max-width: 640px) 100vw, 640px\" class=\"wp-block-cover__image-background wp-image-697 not-transparent\" alt=\"\" src=\"https:\/\/www.qvalitek.com\/wp-content\/uploads\/2024\/07\/640px-Alpha-Gamma_Hot_Cell_Facility_001-1.jpg\" data-object-fit=\"cover\" srcset=\"https:\/\/www.qvalitek.com\/wp-content\/uploads\/2024\/07\/640px-Alpha-Gamma_Hot_Cell_Facility_001-1.jpg 640w, https:\/\/www.qvalitek.com\/wp-content\/uploads\/2024\/07\/640px-Alpha-Gamma_Hot_Cell_Facility_001-1-600x450.jpg 600w, https:\/\/www.qvalitek.com\/wp-content\/uploads\/2024\/07\/640px-Alpha-Gamma_Hot_Cell_Facility_001-1-300x225.jpg 300w, https:\/\/www.qvalitek.com\/wp-content\/uploads\/2024\/07\/640px-Alpha-Gamma_Hot_Cell_Facility_001-1-16x12.jpg 16w\" \/><div class=\"wp-block-cover__inner-container is-layout-constrained wp-block-cover-is-layout-constrained\">\n<p class=\"has-text-align-center has-large-font-size wp-block-paragraph\">Si\u016blome i\u0161sam\u0173 \"hot cells\" validacijos proces\u0105, kuriuo siekiama apsaugoti ir gamin\u012f, ir operatori\u0173.<\/p>\n<\/div><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">U\u017etikrindami radiofarmacini\u0173 preparat\u0173 saugum\u0105 ir veiksmingum\u0105, teikiame validavimo paslaugas pagal GMP (geros gamybos praktikos) reikalavimus.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Validavimo procesas<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. Dizaino kvalifikacija (DQ)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>I\u0161sami\u0173 dizaino specifikacij\u0173 rengimas, u\u017etikrinant atitikt\u012f GMP standartams.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. \u012erengimo kvalifikacija (IQ)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u012erangos montavimo tikrinimas pagal gamintojo specifikacijas ir reglamentuojan\u010dias gaires.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. Eksploatacijos kvalifikacija (OQ)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u012erangos veikimo bandymas numatytomis s\u0105lygomis, siekiant u\u017etikrinti veikimo nuoseklum\u0105.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Pagrindiniai elementai<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Oro \u0161vara<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Atitiktis PSO ir FDA klasifikacijoms, susijusioms su daleli\u0173 dyd\u017eio ir koncentracijos ribin\u0117mis vert\u0117mis.<\/li>\n\n\n\n<li>Mikrobiologin\u0117s steb\u0117senos program\u0173, apiman\u010di\u0173 or\u0105, pavir\u0161ius ir asmenis, \u012fgyvendinimas<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Izoliatoriaus vientisumas<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>U\u017etikrinti, kad izoliatoriai b\u016bt\u0173 sandar\u016bs ir pagaminti i\u0161 med\u017eiagos, atsparios pa\u017eeidimams.<\/li>\n\n\n\n<li>\u012eprastinis izoliatori\u0173 ir pir\u0161tini\u0173 ir rankovi\u0173 sistem\u0173 oro kokyb\u0117s ir dezinfekavimo testavimas.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Aplinkos kontrol\u0117<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Neigiamo sl\u0117gio gradiento palaikymas, kad b\u016bt\u0173 i\u0161vengta u\u017eter\u0161imo.<\/li>\n\n\n\n<li>Steb\u0117ti oro sraut\u0105, filtro vientisum\u0105 ir daleli\u0173 kiek\u012f tiek ramyb\u0117s b\u016bsenoje, tiek darbo metu.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Atitiktis ir steb\u0117sena<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Teis\u0117s akt\u0173 laikymasis<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Atitikti tarptautini\u0173 institucij\u0173, toki\u0173 kaip FDA, \"EudraLex\" ir ISO, standartus.<\/li>\n\n\n\n<li>Bendradarbiaujant su gamintojo kokyb\u0117s u\u017etikrinimo skyriumi parengti patikim\u0105 pagrindin\u012f validavimo plan\u0105.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u012eprastinis testavimas<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Nuolatinis patvirtinimas, \u012fskaitant HEPA filtr\u0173 bandymus, oro grei\u010dio matavimus ir sandarumo bandymus, siekiant u\u017etikrinti nuolatin\u0119 atitikt\u012f.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">I\u0161vada<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">M\u016bs\u0173 teikiamos radiofarmacini\u0173 \"hot cell\" sistem\u0173 validavimo paslaugos yra skirtos u\u017etikrinti atitikt\u012f GMP reikalavimams, apsaugoti produkto kokyb\u0119 ir operatoriaus saug\u0105. Atlikdami kruop\u0161\u010dius bandymus ir laikydamiesi tarptautini\u0173 standart\u0173, padedame i\u0161laikyti auk\u0161\u010diausi\u0105 veiklos patikimumo lyg\u012f radiofarmacini\u0173 preparat\u0173 gamybos aplinkoje.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Susisiekite:<\/strong> Susisiekite su Qvalitek ir su\u017einokite daugiau.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<div id=\"wp-block-themeisle-blocks-button-group-415d7592\" class=\"wp-block-themeisle-blocks-button-group wp-block-buttons align-center-desktop\">\n<div id=\"wp-block-themeisle-blocks-button-9414febf\" class=\"wp-block-themeisle-blocks-button wp-block-button\"><a href=\"https:\/\/www.qvalitek.com\/lt\/contact-us\/\" target=\"_self\" rel=\"noopener noreferrer\" class=\"wp-block-button__link\"><span><strong>Susisiekite!<\/strong><\/span><\/a><\/div>\n<\/div>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>","protected":false},"excerpt":{"rendered":"<p>Ensuring the safety and efficacy of radiopharmaceuticals, our validation services adhere to GMP (Good Manufacturing Practices) requirements. Validation Process 1. Design Qualification (DQ) 2. Installation Qualification (IQ) 3. Operational Qualification (OQ) Key Elements Air Cleanliness Isolator Integrity Environmental Controls Compliance and Monitoring Regulatory Adherence Routine Testing Conclusion Our validation services [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_themeisle_gutenberg_block_has_review":false,"footnotes":""},"class_list":["post-695","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Radiopharmaceuticals Hot Cells Qualification - QVALITEK<\/title>\n<meta name=\"description\" content=\"We provide comprehensive validation steps for hot cells, focusing on protecting both the product and the operator.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.qvalitek.com\/lt\/radiopharmaceuticals-hot-cells-validation-services\/\" \/>\n<meta property=\"og:locale\" content=\"lt_LT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Radiopharmaceuticals Hot Cells Qualification - 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