{"id":2175,"date":"2023-05-10T15:40:58","date_gmt":"2023-05-10T07:40:58","guid":{"rendered":"https:\/\/www.qualitester.com\/?p=2175"},"modified":"2023-05-10T16:14:47","modified_gmt":"2023-05-10T08:14:47","slug":"requirements-and-methods-for-physical-performance-testing-of-medicinal-ointment-tubes","status":"publish","type":"post","link":"https:\/\/www.qualitester.com\/da\/requirements-and-methods-for-physical-performance-testing-of-medicinal-ointment-tubes\/","title":{"rendered":"Krav og metoder til test af fysisk ydeevne for r\u00f8r til medicinske salver"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"2175\" class=\"elementor elementor-2175\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6ccadbd e-flex e-con-boxed e-con e-parent\" data-id=\"6ccadbd\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9167143 elementor-widget elementor-widget-text-editor\" data-id=\"9167143\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>En salve er et halvfast pr\u00e6parat til udvortes brug med en bestemt konsistens, der fremstilles ved at blande et l\u00e6gemiddel j\u00e6vnt med en egnet b\u00e6restof. Salven er anbragt i en komposit-tube af polyethylen\/aluminium\/polyethylen. For at sikre l\u00e6gemidlets sikkerhed og stabilitet under distribution og brug stiller standarden for emballagemateriale til l\u00e6gemidler en r\u00e6kke krav til de fysiske egenskaber ved emballagen til salvetuber. I det f\u00f8lgende vil vi pr\u00e6sentere ydeevnekravene og testmetoderne for farmaceutiske salve-tuber af polyethylen\/aluminium\/polyethylen-komposit i kombination med kravene i de nationale standarder for farmaceutisk emballagemateriale.<\/p><p><strong>Referencestandard (del):<\/strong><\/p><p>YBB00252005-2015 Medicinsk salvebeholder af polyethylen\/aluminium\/polyethylen-komposit<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-93d8ecd e-flex e-con-boxed e-con e-parent\" data-id=\"93d8ecd\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d883484 elementor-widget elementor-widget-text-editor\" data-id=\"d883484\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>Trykstyrke<\/strong><\/p><p>Tag en passende m\u00e6ngde pr\u00f8ve, stram r\u00f8rets h\u00e6tte med et drejningsmoment p\u00e5 30\u201390 N\u00b7cm, tilf\u00f8r trykluft fra r\u00f8rets ende (lufttrykket skal v\u00e6re 0,2 MPa), anbring det i et vandbad ved 20 \u00b0C \u00b1 2 \u00b0C, oprethold trykket i 30 sekunder, der m\u00e5 ikke forekomme brud, og der m\u00e5 ikke v\u00e6re luftbobler ved svejsesamlingerne. .<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-77e9165 e-flex e-con-boxed e-con e-parent\" data-id=\"77e9165\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-10838ad e-con-full e-flex e-con e-parent\" data-id=\"10838ad\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-218f13b elementor-widget elementor-widget-image\" data-id=\"218f13b\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.qualitester.com\/da\/vare\/torque-tester-tt-01\/\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"750\" height=\"750\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/TT-01-Torque-Tester-2.jpg\" class=\"attachment-large size-large wp-image-1941\" alt=\"\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/TT-01-Torque-Tester-2.jpg 750w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/TT-01-Torque-Tester-2-300x300.jpg 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/TT-01-Torque-Tester-2-150x150.jpg 150w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/TT-01-Torque-Tester-2-600x600.jpg 600w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/TT-01-Torque-Tester-2-100x100.jpg 100w\" sizes=\"(max-width: 750px) 100vw, 750px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2d33e09 e-con-full e-flex e-con e-parent\" data-id=\"2d33e09\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6fb7f25 elementor-widget elementor-widget-image\" data-id=\"6fb7f25\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.qualitester.com\/da\/vare\/leak-and-seal-strength-tester-lsst-01\/\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"750\" height=\"750\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Leak-and-Seal-Strength-Tester-LSST-01-1.jpg\" class=\"attachment-large size-large wp-image-1717\" alt=\"\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Leak-and-Seal-Strength-Tester-LSST-01-1.jpg 750w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Leak-and-Seal-Strength-Tester-LSST-01-1-300x300.jpg 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Leak-and-Seal-Strength-Tester-LSST-01-1-150x150.jpg 150w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Leak-and-Seal-Strength-Tester-LSST-01-1-600x600.jpg 600w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Leak-and-Seal-Strength-Tester-LSST-01-1-100x100.jpg 100w\" sizes=\"(max-width: 750px) 100vw, 750px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-02a1107 e-flex e-con-boxed e-con e-parent\" data-id=\"02a1107\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-742766b e-con-full e-flex e-con e-parent\" data-id=\"742766b\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8547dc1 elementor-widget elementor-widget-text-editor\" data-id=\"8547dc1\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h5><a href=\"https:\/\/www.qualitester.com\/da\/vare\/torque-tester-tt-01\/\">TT-01 Momenttester<\/a><\/h5>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-862de1e e-con-full e-flex e-con e-parent\" data-id=\"862de1e\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-520c122 elementor-widget elementor-widget-text-editor\" data-id=\"520c122\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h5><a href=\"https:\/\/www.qualitester.com\/da\/vare\/leak-and-seal-strength-tester-lsst-01\/\">LSST-01 Test af l\u00e6kage- og forseglingsstyrke<\/a><\/h5>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-971e658 e-flex e-con-boxed e-con e-parent\" data-id=\"971e658\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f4da006 elementor-widget elementor-widget-text-editor\" data-id=\"f4da006\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>Afskalningsstyrke mellem det indre lag og det underliggende indre lag<\/strong><\/p>\n<p>Der udtages en passende m\u00e6ngde pr\u00f8ver, som m\u00e5les i henhold til pr\u00f8vningsmetoden for afskalningsstyrke (YBB00102003-2015). Gennemsnitsv\u00e6rdien af den langsg\u00e5ende og tv\u00e6rg\u00e5ende afskalningsstyrke m\u00e5 ikke v\u00e6re mindre end 5,0 N\/15 mm.<\/p>\n<p>Testkrav til afskalningsstyrke i testmetoden YBB00102003-2015 for afskalningsstyrke:<\/p>\n<p>Sp\u00e6nd begge ender af pr\u00f8ven fast i testmaskinens \u00f8vre og nedre klemmeanordninger, s\u00e5ledes at l\u00e6ngdeaksen p\u00e5 den afisolede del af pr\u00f8ven falder sammen med midterlinjen p\u00e5 de \u00f8vre og nedre klemmer, og s\u00e5 sp\u00e6ndingen er passende. Under pr\u00f8ven skal den ikke-afskallede del og tr\u00e6kretningen danne et T, pr\u00f8vehastigheden skal v\u00e6re 300 mm\/min \u00b1 30 mm\/min, og afskalningskraftkurven under pr\u00f8veemnets afskalningsproces registreres.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7c8d77b e-flex e-con-boxed e-con e-parent\" data-id=\"7c8d77b\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5c74a75 elementor-widget elementor-widget-image\" data-id=\"5c74a75\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.qualitester.com\/da\/vare\/tensile-tester-tst-01\/\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"750\" height=\"750\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Tensile-Tester-TST-01-Right-view.jpg\" class=\"attachment-large size-large wp-image-56\" alt=\"\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Tensile-Tester-TST-01-Right-view.jpg 750w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Tensile-Tester-TST-01-Right-view-300x300.jpg 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Tensile-Tester-TST-01-Right-view-100x100.jpg 100w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Tensile-Tester-TST-01-Right-view-600x600.jpg 600w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Tensile-Tester-TST-01-Right-view-150x150.jpg 150w\" sizes=\"(max-width: 750px) 100vw, 750px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e41e046 e-flex e-con-boxed e-con e-parent\" data-id=\"e41e046\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-46ff2ba elementor-widget elementor-widget-text-editor\" data-id=\"46ff2ba\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h5><a href=\"https:\/\/www.qualitester.com\/da\/vare\/tensile-tester-tst-01\/\"><strong>TST-01 Tr\u00e6kpr\u00f8vemaskine<\/strong><\/a><\/h5>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7f38b0d e-flex e-con-boxed e-con e-parent\" data-id=\"7f38b0d\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-49f5335 elementor-widget elementor-widget-text-editor\" data-id=\"49f5335\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><strong>Tr\u00e6kstyrke<\/strong><\/p><p>Tag kompositr\u00f8ret med samme batchnummer, og m\u00e5l det i henhold til metoden til m\u00e5ling af tr\u00e6kegenskaber (YBB00112003-2015). Der anvendes type II-pr\u00f8ver, og pr\u00f8vehastigheden er 100 mm\/min \u00b1 10 mm\/min. Registrer belastningen, n\u00e5r det f\u00f8rste lag af materialet brister; dette er tr\u00e6kstyrken. Tr\u00e6kstyrken m\u00e5 hverken i lodret eller vandret retning v\u00e6re lavere end 16,0 MPa.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-af4d4f3 e-flex e-con-boxed e-con e-parent\" data-id=\"af4d4f3\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c7233fa elementor-widget elementor-widget-image\" data-id=\"c7233fa\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.qualitester.com\/da\/vare\/tensile-tester-tst-01\/\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"750\" height=\"750\" src=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Tensile-Tester-TST-01-Right-view.jpg\" class=\"attachment-large size-large wp-image-56\" alt=\"\" srcset=\"https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Tensile-Tester-TST-01-Right-view.jpg 750w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Tensile-Tester-TST-01-Right-view-300x300.jpg 300w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Tensile-Tester-TST-01-Right-view-100x100.jpg 100w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Tensile-Tester-TST-01-Right-view-600x600.jpg 600w, https:\/\/www.qualitester.com\/wp-content\/uploads\/2023\/04\/Tensile-Tester-TST-01-Right-view-150x150.jpg 150w\" sizes=\"(max-width: 750px) 100vw, 750px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e063ab3 e-flex e-con-boxed e-con e-parent\" data-id=\"e063ab3\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7d698eb elementor-widget elementor-widget-text-editor\" data-id=\"7d698eb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<h5><a href=\"https:\/\/www.qualitester.com\/da\/vare\/tensile-tester-tst-01\/\">TST-01 Tr\u00e6kpr\u00f8vemaskine<\/a><\/h5>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3fda63f e-flex e-con-boxed e-con e-parent\" data-id=\"3fda63f\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ed6215a elementor-widget elementor-widget-wpforms\" data-id=\"ed6215a\" data-element_type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<div class=\"wpforms-container\" id=\"wpforms-11\"><form id=\"wpforms-form-11\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"11\" 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value=\"da\"\/><\/form><\/div>  <!-- .wpforms-container -->\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Salve refererer til et halvfast eksternt pr\u00e6parat med en vis konsistens, der fremstilles ved ensartet at blande et l\u00e6gemiddel med en passende base. Salven er indeholdt i et kompositr\u00f8r af polyethylen\/aluminium\/polyethylen. For at sikre l\u00e6gemidlets sikkerhed og stabilitet under cirkulation og brug stiller standarden for l\u00e6gemiddelemballage nogle krav til ...<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/www.qualitester.com\/da\/requirements-and-methods-for-physical-performance-testing-of-medicinal-ointment-tubes\/\"> <span class=\"screen-reader-text\">Krav og metoder til test af fysisk ydeevne for r\u00f8r til medicinske salver<\/span> L\u00e6s mere \"<\/a><\/p>","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-global-header-display":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","footnotes":""},"categories":[1],"tags":[328,329,286],"class_list":["post-2175","post","type-post","status-publish","format-standard","hentry","category-test-method","tag-compressive-strength","tag-peel-strength","tag-tensile-strength"],"_links":{"self":[{"href":"https:\/\/www.qualitester.com\/da\/wp-json\/wp\/v2\/posts\/2175","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.qualitester.com\/da\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.qualitester.com\/da\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/da\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.qualitester.com\/da\/wp-json\/wp\/v2\/comments?post=2175"}],"version-history":[{"count":0,"href":"https:\/\/www.qualitester.com\/da\/wp-json\/wp\/v2\/posts\/2175\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.qualitester.com\/da\/wp-json\/wp\/v2\/media?parent=2175"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.qualitester.com\/da\/wp-json\/wp\/v2\/categories?post=2175"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.qualitester.com\/da\/wp-json\/wp\/v2\/tags?post=2175"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}