{"id":54841,"date":"2022-08-19T11:51:04","date_gmt":"2022-08-19T09:51:04","guid":{"rendered":"https:\/\/www.oncomed.cz\/?post_type=studies&#038;p=54841"},"modified":"2025-08-18T14:54:33","modified_gmt":"2025-08-18T12:54:33","slug":"presun-stabilit-do-novych-prostor","status":"publish","type":"studies","link":"https:\/\/www.oncomed.cz\/cs\/blog\/presun-stabilit-do-novych-prostor\/","title":{"rendered":"P\u0159esun stabilit do nov\u00fdch prostor"},"content":{"rendered":"<div class=\"text-small py-4\">\n  <div><p>oncomed v\u00a0minul\u00fdch m\u011bs\u00edc\u00edch p\u0159esunul stabilitn\u00ed prostory do nov\u00e9 budovy, \u010d\u00edm\u017e se v\u00fdznamn\u011b nav\u00fd\u0161ily kapacity pro skladov\u00e1n\u00ed. Tento krok v\u0161ak p\u0159estavuje mnoho dal\u0161\u00edch v\u00fdhod pro sou\u010dasn\u00e9 i nov\u00e9 z\u00e1kazn\u00edky, o kter\u00fdch bychom se s\u00a0V\u00e1mi r\u00e1di pod\u011blili v\u00a0tomto \u010dl\u00e1nku.<\/p>\n<p>Skladov\u00e1n\u00ed a testov\u00e1n\u00ed stability je d\u016fle\u017eitou sou\u010d\u00e1st\u00ed p\u0159i v\u00fdvoji l\u00e9k\u016f. Prov\u00e1d\u00ed se za \u00fa\u010delem zji\u0161t\u011bn\u00ed, jak se kvalita l\u00e9\u010div\u00e9 l\u00e1tky nebo l\u00e9\u010div\u00e9ho produktu m\u011bn\u00ed s \u010dasem pod vlivem faktor\u016f prost\u0159ed\u00ed, jako je teplota, vlhkost a sv\u011btlo.<\/p>\n<p>Outsourcing stabilitn\u00edch studi\u00ed je v\u00fdhodn\u00fdm \u0159e\u0161en\u00edm pro farmaceutick\u00e9 firmy, kter\u00fdm p\u0159ed\u00e1n\u00ed t\u011bchto rutinn\u00edch, ale \u017eivotn\u011b d\u016fle\u017eit\u00fdch studi\u00ed odborn\u00edk\u016fm se zavedenou kapacitou sni\u017euje n\u00e1klady a umo\u017e\u0148uje soust\u0159edit se na v\u00fdzkum a v\u00fdvoj nov\u00fdch l\u00e9k\u016f.<\/p>\n<p>N\u00e1\u0161 servis zahrnuje registra\u010dn\u00ed a pr\u016fb\u011b\u017en\u00e9 stabilitn\u00ed studie dle ICH Q1A(R2) po\u017eadavk\u016f, studie fotostability dle ICH Q1B, infuzn\u00ed stability, transportn\u00ed studie a skladov\u00e1n\u00ed vzork\u016f.<\/p>\n<p>P\u0159esunem stabilit do nov\u00fdch prostor se na\u0161e kapacity pro skladov\u00e1n\u00ed signifikantn\u011b nav\u00fd\u0161ily:<\/p>\n<ul>\n<li>25\u00b0C\/60%RH: nav\u00fd\u0161en\u00ed o 85 %<\/li>\n<li>30\u00b0C\/65%RH: nav\u00fd\u0161en\u00ed o 100 %<\/li>\n<li>2\u20138 \u00b0C: nav\u00fd\u0161en\u00ed o 35 % s\u00a0mo\u017enost\u00ed dal\u0161\u00edho roz\u0161\u00ed\u0159en\u00ed<\/li>\n<\/ul>\n<p>Dal\u0161\u00edm benefitem p\u0159esunu je skute\u010dnost, \u017ee nyn\u00ed jsou v\u0161echny stabilitn\u00ed vzorky na jednom m\u00edst\u011b. Nav\u00edc je zde mo\u017enost pro p\u0159id\u00e1n\u00ed dal\u0161\u00edch stabilitn\u00edch komor na nov\u00e9 stabilitn\u00ed podm\u00ednky v\u00a0p\u0159\u00edpad\u011b pot\u0159eby. Samostatn\u00e9 prostory mimo v\u00fdrobn\u00ed budovu nav\u00edc zaru\u010duj\u00ed lep\u0161\u00ed kontrolu p\u0159\u00edstupu do jednotliv\u00fdch m\u00edstnost\u00ed a komor.<\/p>\n<p>Nov\u00e9 stabilitn\u00ed m\u00edstnosti maj\u00ed lep\u0161\u00ed konstrukci ne\u017e ty p\u016fvodn\u00ed \u2013 izolace st\u011bn m\u00edstnost\u00ed zaru\u010duje ni\u017e\u0161\u00ed spot\u0159ebu energi\u00ed, a d\u00edky perforovan\u00fdm polic\u00edm je zaji\u0161t\u011bna lep\u0161\u00ed homogenita klimatick\u00fdch podm\u00ednek.<\/p>\n<p>Jak je z\u0159ejm\u00e9 z v\u00fd\u0161e uveden\u00e9ho, b\u011bhem procesu p\u0159emis\u0165ov\u00e1n\u00ed instalace \u00falo\u017ei\u0161t\u011b stabilit muselo b\u00fdt vzato v \u00favahu mnoho aspekt\u016f. A\u010dkoliv si tento krok vy\u017e\u00e1dal zna\u010dnou investici, m\u016f\u017eeme d\u00edky n\u00ed nab\u00eddnout vy\u0161\u0161\u00ed skladovac\u00ed kapacity a efektivn\u00ed testov\u00e1n\u00ed stabilit, a t\u00edm zajistit co nejlep\u0161\u00ed kvalitu slu\u017eeb v\u0161em na\u0161im z\u00e1kazn\u00edk\u016fm.<\/p>\n<\/div>\n<\/div>\n\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1380\" height=\"1920\" data-id=\"54826\" src=\"https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094616.jpg\" alt=\"\" class=\"wp-image-54826\" srcset=\"https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094616.jpg 1380w, https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094616-216x300.jpg 216w, https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094616-736x1024.jpg 736w, https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094616-768x1069.jpg 768w, https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094616-1104x1536.jpg 1104w\" sizes=\"auto, (max-width: 1380px) 100vw, 1380px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1920\" height=\"1440\" data-id=\"54830\" src=\"https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094848.jpg\" alt=\"\" class=\"wp-image-54830\" srcset=\"https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094848.jpg 1920w, https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094848-300x225.jpg 300w, https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094848-1024x768.jpg 1024w, https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094848-768x576.jpg 768w, https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094848-1536x1152.jpg 1536w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1440\" height=\"1920\" data-id=\"54828\" src=\"https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094630.jpg\" alt=\"\" class=\"wp-image-54828\" srcset=\"https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094630.jpg 1440w, https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094630-225x300.jpg 225w, https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094630-768x1024.jpg 768w, https:\/\/www.oncomed.cz\/wp-content\/uploads\/20220630-094630-1152x1536.jpg 1152w\" sizes=\"auto, (max-width: 1440px) 100vw, 1440px\" \/><\/figure>\n<\/figure>\n","protected":false},"author":3,"featured_media":0,"template":"","meta":{"_acf_changed":false,"advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories_studies":[13],"class_list":["post-54841","studies","type-studies","status-publish","hentry"],"acf":[],"aioseo_notices":[],"featured_img":false,"coauthors":[],"author_meta":{"author_link":"https:\/\/www.oncomed.cz\/cs\/author\/jorova\/","display_name":"Zuzana Jorov\u00e1"},"relative_dates":{"created":"Posted 4 roky ago","modified":"Updated 9 m\u011bs\u00edc\u016f ago"},"absolute_dates":{"created":"Posted on 19. 8. 2022","modified":"Updated on 18. 8. 2025"},"absolute_dates_time":{"created":"Posted on 19. 8. 2022 11:51","modified":"Updated on 18. 8. 2025 14:54"},"featured_img_caption":"","tax_additional":{"categories_studies":{"linked":["<a href=\"https:\/\/www.oncomed.cz\/en\/?categories_studies=articles\" class=\"advgb-post-tax-term\">\u010cl\u00e1nky<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">\u010cl\u00e1nky<\/span>"],"slug":"categories_studies","name":"Kategorie blogu"},"translation_priority":{"linked":["<a href=\"https:\/\/www.oncomed.cz\/cs\/?taxonomy=translation_priority&#038;term=optional-cs\" class=\"advgb-post-tax-term\">Optional<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Optional<\/span>"],"slug":"translation_priority","name":"Translation Priorities"}},"series_order":"","_links":{"self":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies\/54841","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies"}],"about":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/types\/studies"}],"version-history":[{"count":3,"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies\/54841\/revisions"}],"predecessor-version":[{"id":59480,"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/studies\/54841\/revisions\/59480"}],"wp:attachment":[{"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/media?parent=54841"}],"wp:term":[{"taxonomy":"categories_studies","embeddable":true,"href":"https:\/\/www.oncomed.cz\/cs\/wp-json\/wp\/v2\/categories_studies?post=54841"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}