{"id":463,"date":"2025-07-03T14:13:38","date_gmt":"2025-07-03T06:13:38","guid":{"rendered":"https:\/\/www.ampouletest.com\/?page_id=463"},"modified":"2026-02-02T08:15:39","modified_gmt":"2026-02-02T00:15:39","slug":"iso-8871-5","status":"publish","type":"page","link":"https:\/\/www.ampouletest.com\/nl\/iso-8871-5","title":{"rendered":"ISO 8871-5"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"463\" class=\"elementor elementor-463\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-c60fdbb e-flex e-con-boxed e-con e-parent\" data-id=\"c60fdbb\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-db6fcba e-con-full e-flex e-con e-child\" data-id=\"db6fcba\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-9d1f798 e-con-full e-flex e-con e-child\" data-id=\"9d1f798\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-8cc5a79 e-con-full e-flex e-con e-child\" data-id=\"8cc5a79\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b6b67d4 elementor-widget elementor-widget-heading\" data-id=\"b6b67d4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">ISO 8871-5<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5a032b0 elementor-widget elementor-widget-heading\" data-id=\"5a032b0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Testen van de elastomere sluiting van ampullen<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c754e2a elementor-widget elementor-widget-text-editor\" data-id=\"c754e2a\" 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\t\t<p data-start=\"391\" data-end=\"1146\">In de farmaceutische industrie is het waarborgen van de integriteit van verpakkingscomponenten zoals elastomere sluitingen van cruciaal belang voor de veiligheid en werkzaamheid van producten. <strong data-start=\"562\" data-end=\"576\">ISO 8871-5<\/strong> schetst de <strong data-start=\"590\" data-end=\"654\">functionele eisen en testmethoden voor rubberstoppen<\/strong> gebruikt met parenterale containers, met name flacons en ampullen. Deze norm heeft betrekking op verschillende testprocedures, waaronder de <strong data-start=\"780\" data-end=\"822\">doordringbaarheidstest voor rubberstoppen<\/strong>, <strong data-start=\"857\" data-end=\"878\">ampul lektest<\/strong>zoals <strong data-start=\"880\" data-end=\"911\">testmethode voor de dichtheid van de kleurstofoplossing<\/strong>, <strong data-start=\"913\" data-end=\"937\">zelfdichtende testmethode<\/strong>en <strong data-start=\"943\" data-end=\"963\">methode voor vacu\u00fcmlektest<\/strong>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-69e503e elementor-button-align-stretch elementor-widget elementor-widget-form\" data-id=\"69e503e\" data-element_type=\"widget\" data-settings=\"{&quot;button_width&quot;:&quot;20&quot;,&quot;step_next_label&quot;:&quot;Next&quot;,&quot;step_previous_label&quot;:&quot;Previous&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" name=\"New Form\" action=\"\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"463\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"69e503e\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"Ampoule Test\" \/>\n\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-above\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-name elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-name\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tNaam\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[name]\" id=\"form-field-name\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Naam\" required=\"required\" aria-required=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-field_e89647e elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-field_e89647e\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tBedrijf\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[field_e89647e]\" id=\"form-field-field_e89647e\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"Bedrijf\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tE-mail\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"E-mail\" required=\"required\" aria-required=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-message\" class=\"elementor-field-label\">\n\t\t\t\t\t\t\t\tBericht\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t<textarea class=\"elementor-field-textual elementor-field  elementor-size-sm\" name=\"form_fields[message]\" id=\"form-field-message\" rows=\"4\" placeholder=\"Bericht\"><\/textarea>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-recaptcha_v3 elementor-field-group elementor-column elementor-field-group-field_5682c8b elementor-col-100 recaptcha_v3-bottomright\">\n\t\t\t\t\t<div class=\"elementor-field\" id=\"form-field-field_5682c8b\"><div class=\"elementor-g-recaptcha\" data-sitekey=\"6LeuX60rAAAAAElodUi54YrM7mqC6fGZX8tx93-Z\" data-type=\"v3\" data-action=\"Form\" data-badge=\"bottomright\" data-size=\"invisible\"><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-group elementor-column elementor-field-type-submit elementor-col-20 e-form__buttons\">\n\t\t\t\t\t<button class=\"elementor-button elementor-size-sm\" type=\"submit\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Stuur<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/button>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<input type=\"hidden\" name=\"trp-form-language\" value=\"nl\"\/><\/form>\n\t\t\t\t\t\t<\/div>\n\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-163fe1b e-con-full e-flex e-con e-child\" data-id=\"163fe1b\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\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-f29ff9c e-flex e-con-boxed e-con e-parent\" data-id=\"f29ff9c\" 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-fadf197 elementor-widget elementor-widget-heading\" data-id=\"fadf197\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">ISO 8871-5 begrijpen<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7e073a9 elementor-widget elementor-widget-text-editor\" data-id=\"7e073a9\" 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\t\t<p data-start=\"1063\" data-end=\"1554\">ISO 8871-5 maakt deel uit van een serie die zich richt op elastomere onderdelen voor farmaceutisch gebruik. <strong data-start=\"1278\" data-end=\"1288\">Deel 5<\/strong> richt zich specifiek op de <strong data-start=\"1316\" data-end=\"1368\">functionele prestaties en integriteit van sluitingen<\/strong> die in verbinding staan met injectiesystemen. Het doel is om ervoor te zorgen dat sluitingen penetratie met redelijke kracht mogelijk maken, na doorboring weer afdichten en contaminatie of lekkage onder stressomstandigheden voorkomen.<\/p>\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-fcfe601 e-flex e-con-boxed e-con e-parent\" data-id=\"fcfe601\" 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-285ac2f elementor-widget elementor-widget-heading\" data-id=\"285ac2f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Doordringbaarheidstest voor rubberstoppers<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-030866f e-con-full e-flex e-con e-child\" data-id=\"030866f\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3c265f6 elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"3c265f6\" 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<figure class=\"wp-caption\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.ampouletest.com\/nl\/glass-grain-hydrolytic-resistance-tester-usp-iso\/\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"768\" height=\"1580\" src=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-768x1580.webp\" class=\"attachment-medium_large size-medium_large wp-image-457\" alt=\"Doordringbaarheidstester voor rubberstoppen van ampullen\" srcset=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-768x1580.webp 768w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-146x300.webp 146w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-498x1024.webp 498w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-747x1536.webp 747w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-995x2048.webp 995w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-scaled.webp 1244w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t<figcaption class=\"widget-image-caption wp-caption-text\">Doordringbaarheidstest<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a8ac35c e-con-full e-flex e-con e-child\" data-id=\"a8ac35c\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e3de559 elementor-widget elementor-widget-text-editor\" data-id=\"e3de559\" 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\t\t<p>De <strong data-start=\"1630\" data-end=\"1652\">doordringbaarheidstest<\/strong>, gedefinieerd in <strong data-start=\"1665\" data-end=\"1676\">Bijlage A<\/strong> van ISO 8871-5 evalueert de kracht die nodig is om een elastomere sluiting te doorboren met een injectienaald.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a478b24 elementor-widget elementor-widget-heading\" data-id=\"a478b24\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Principe<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f528437 elementor-widget elementor-widget-text-editor\" data-id=\"f528437\" 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\t\t<p>Een sluiting wordt onder standaardomstandigheden getest om de maximale kracht te meten die een naald nodig heeft om er doorheen te dringen. Een te grote penetratiekracht kan de bruikbaarheid en de veiligheid van de pati\u00ebnt in gevaar brengen.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ab57be0 elementor-widget elementor-widget-heading\" data-id=\"ab57be0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Testprocedure<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d7fbaf5 elementor-widget elementor-widget-text-editor\" data-id=\"d7fbaf5\" 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\t\t<ul><li data-start=\"2007\" data-end=\"2064\">Bevestig de rubberen stoppen op flesjes met krimpsluitingen.<\/li><li data-start=\"2067\" data-end=\"2169\">Een <strong data-start=\"2075\" data-end=\"2101\">krachtmeetapparaat<\/strong> zoals de <strong data-start=\"2114\" data-end=\"2141\">Cel Instrumenten NPT-01<\/strong> met een injectienaald.<\/li><li data-start=\"2172\" data-end=\"2209\">Doorboor de stop loodrecht.<\/li><li data-start=\"2212\" data-end=\"2245\">Noteer de vereiste piekkracht.<\/li><li data-start=\"2248\" data-end=\"2307\">Herhaal dit met nieuwe naalden op andere monsters (10 in totaal).<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-72096bf elementor-widget elementor-widget-heading\" data-id=\"72096bf\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Betekenis<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b451adc elementor-widget__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"b451adc\" 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\t\t<p>Deze test simuleert het echte gebruik van <strong data-start=\"2370\" data-end=\"2390\">flacons met meerdere doses<\/strong> en zorgt voor <strong data-start=\"2403\" data-end=\"2429\">gebruiksgemak<\/strong> met behoud van steriliteit.<\/p>\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<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6d5e9de e-flex e-con-boxed e-con e-parent\" data-id=\"6d5e9de\" 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-b64435d elementor-widget elementor-widget-heading\" data-id=\"b64435d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Ampul vacu\u00fcmlektest<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-59a8695 e-con-full e-flex e-con e-child\" data-id=\"59a8695\" data-element_type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-efb61d0 e-con-full e-flex e-con e-child\" data-id=\"efb61d0\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8e82f12 elementor-widget elementor-widget-heading\" data-id=\"8e82f12\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Zelfdichtende en kleurstofoplossende dichtheidstest<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7d65f4e elementor-widget elementor-widget-text-editor\" data-id=\"7d65f4e\" 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\t\t<p data-start=\"2465\" data-end=\"2648\"><strong data-start=\"2516\" data-end=\"2527\">Bijlage C<\/strong> van ISO 8871-5 beschrijft een gecombineerde <strong data-start=\"2562\" data-end=\"2586\">zelfdichtend testen<\/strong> en <strong data-start=\"2591\" data-end=\"2622\">dichtheidstest met kleurstofoplossing<\/strong> na herhaaldelijk prikken.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1394e99 elementor-widget elementor-widget-heading\" data-id=\"1394e99\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Principe<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ecccfe7 elementor-widget elementor-widget-text-editor\" data-id=\"ecccfe7\" 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\t\t<p data-start=\"2666\" data-end=\"2820\">De test controleert het vermogen van een stopper om opnieuw af te sluiten na meerdere penetraties en om weerstand te bieden aan lekkage wanneer deze wordt blootgesteld aan vacu\u00fcmge\u00efnduceerde drukverschillen.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-73c3270 elementor-widget elementor-widget-heading\" data-id=\"73c3270\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Testprocedure<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3b4d220 elementor-widget elementor-widget-text-editor\" data-id=\"3b4d220\" 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\t\t<ul><li data-start=\"2845\" data-end=\"2910\">Vul 10 schone flacons met deeltjesvrij water tot het nominale volume.<\/li><li data-start=\"2913\" data-end=\"2953\">Sluit af met de testsluitingen en krimp.<\/li><li data-start=\"2956\" data-end=\"3016\">Prik elke sluiting 10 keer door met telkens een nieuwe naald.<\/li><li data-start=\"3019\" data-end=\"3071\">Dompel de flesjes onder in methyleenblauwe kleurstofoplossing.<\/li><li data-start=\"3074\" data-end=\"3151\">Pas vacu\u00fcm toe (-27 kPa) gedurende 10 minuten en ga dan terug naar atmosferische druk.<\/li><li data-start=\"3154\" data-end=\"3217\">Laat nog eens 30 minuten zitten, spoel af en controleer.<\/li><li data-start=\"3220\" data-end=\"3283\"><strong data-start=\"3220\" data-end=\"3282\">Een blauwe kleur in de flacon duidt op een mislukte verzegeling.<\/strong>.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6c739f4 elementor-widget elementor-widget-heading\" data-id=\"6c739f4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Ampullektest met kleurstofoplossing (Bijlage D)<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-183e820 elementor-widget elementor-widget-text-editor\" data-id=\"183e820\" 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\t\t<p data-start=\"3470\" data-end=\"3644\">Deze test beoordeelt specifiek de <strong data-start=\"3559\" data-end=\"3595\">integriteit van sluiting\/vial-interface<\/strong> onder stressomstandigheden zonder voorafgaande prikken.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8f7dd3b elementor-widget elementor-widget-heading\" data-id=\"8f7dd3b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Procedure Samenvatting<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-951cd8f elementor-widget elementor-widget-text-editor\" data-id=\"951cd8f\" 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\t\t<ul><li>Vul, verzegel en dop de flesjes.<\/li><li>Dompel ze onder in <strong data-start=\"3723\" data-end=\"3745\">methyleen blauwe kleurstof<\/strong>.<\/li><li>Pas vacu\u00fcm toe en onderhoud volgens het protocol.<\/li><li>Inspecteer op binnendringen van kleurstof na onderdompeling.<\/li><li><strong data-start=\"3846\" data-end=\"3886\">Aanwezigheid van kleurstof binnenin duidt op een lek<\/strong>.<\/li><\/ul><p data-start=\"3889\" data-end=\"4030\">Deze test is cruciaal voor <strong data-start=\"3915\" data-end=\"3946\">protocollen voor ampullektests<\/strong> waar sluitingen steriel moeten blijven, zelfs onder druk van transport of opslag.<\/p>\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<div class=\"elementor-element elementor-element-f219514 elementor-widget elementor-widget-image\" data-id=\"f219514\" 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\t<img decoding=\"async\" width=\"461\" height=\"800\" src=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/ampoule-leak-test.webp\" class=\"attachment-large size-large wp-image-468\" alt=\"iso 8871-5 ampul lektest\" srcset=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/ampoule-leak-test.webp 461w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/ampoule-leak-test-173x300.webp 173w\" sizes=\"(max-width: 461px) 100vw, 461px\" \/>\t\t\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-3abc6b6 e-flex e-con-boxed e-con e-parent\" data-id=\"3abc6b6\" 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-5363c6b elementor-widget elementor-widget-heading\" data-id=\"5363c6b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Waarom deze tests belangrijk zijn<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bcd529d elementor-widget elementor-widget-text-editor\" data-id=\"bcd529d\" 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\t\t<ul><li data-start=\"4068\" data-end=\"4136\"><strong data-start=\"4068\" data-end=\"4087\">Pati\u00ebntveiligheid:<\/strong> Voorkomt vervuiling en variabiliteit in dosering.<\/li><li data-start=\"4139\" data-end=\"4219\"><strong data-start=\"4139\" data-end=\"4165\">Naleving van regelgeving:<\/strong> Voldoet aan strenge farmaceutische QA-vereisten.<\/li><li data-start=\"4222\" data-end=\"4298\"><strong data-start=\"4222\" data-end=\"4244\">Integriteit van het product:<\/strong> Behoudt houdbaarheid en therapeutische effectiviteit.<\/li><\/ul><p data-start=\"4300\" data-end=\"4513\">Door de <strong data-start=\"4318\" data-end=\"4360\">doordringbaarheidstest voor rubberstoppen<\/strong>, <strong data-start=\"4362\" data-end=\"4386\">zelfdichtend testen<\/strong>en <strong data-start=\"4392\" data-end=\"4413\">ampul lektest<\/strong>handhaven fabrikanten normen voor <strong data-start=\"4450\" data-end=\"4482\">parenterale verpakkingssystemen<\/strong> zoals gemandateerd in <strong data-start=\"4498\" data-end=\"4512\">ISO 8871-5<\/strong>.<\/p>\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-b3187b9 e-flex e-con-boxed e-con e-parent\" data-id=\"b3187b9\" 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-17b575a elementor-widget elementor-widget-heading\" data-id=\"17b575a\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Aanbevolen instrumenten van Cell Instruments<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3dd2ff8 elementor-widget elementor-widget-text-editor\" data-id=\"3dd2ff8\" 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\t\t<p>Om nauwkeurige en herhaalbare tests te garanderen, biedt Cell Instruments geavanceerde testoplossingen die aan de voorschriften voldoen:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-11e44c2 e-grid e-con-full e-con e-child\" data-id=\"11e44c2\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-270d427 elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"270d427\" data-element_type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><a href=\"https:\/\/www.ampouletest.com\/nl\/penetrability-tester\/\" tabindex=\"-1\"><img decoding=\"async\" width=\"1244\" height=\"2560\" src=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-scaled.webp\" class=\"attachment-full size-full wp-image-457\" alt=\"Doordringbaarheidstester voor rubberstoppen van ampullen\" srcset=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-scaled.webp 1244w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-146x300.webp 146w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-498x1024.webp 498w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-768x1580.webp 768w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-747x1536.webp 747w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/06\/Penetrability-Tester-for-Ampoule-Rubber-Stoppers-995x2048.webp 995w\" sizes=\"(max-width: 1244px) 100vw, 1244px\" \/><\/a><\/figure><div class=\"elementor-image-box-content\"><h3 class=\"elementor-image-box-title\"><a href=\"https:\/\/www.ampouletest.com\/nl\/penetrability-tester\/\">NPT-01 doordringbaarheidstester<\/a><\/h3><p class=\"elementor-image-box-description\">Geoptimaliseerd voor analyse van de penetratiekracht van elastomere sluitingen.<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d9d79aa elementor-position-top elementor-widget elementor-widget-image-box\" data-id=\"d9d79aa\" data-element_type=\"widget\" data-widget_type=\"image-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-image-box-wrapper\"><figure class=\"elementor-image-box-img\"><img loading=\"lazy\" decoding=\"async\" width=\"461\" height=\"800\" src=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/ampoule-leak-test.webp\" class=\"attachment-full size-full wp-image-468\" alt=\"iso 8871-5 ampul lektest\" srcset=\"https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/ampoule-leak-test.webp 461w, https:\/\/www.ampouletest.com\/wp-content\/uploads\/2025\/07\/ampoule-leak-test-173x300.webp 173w\" sizes=\"(max-width: 461px) 100vw, 461px\" \/><\/figure><div class=\"elementor-image-box-content\"><h3 class=\"elementor-image-box-title\">LT-03 Vacu\u00fcm lektester<\/h3><p class=\"elementor-image-box-description\">Ideaal voor het uitvoeren van vacu\u00fcmondersteunde kleurstofpenetratietests.<\/p><\/div><\/div>\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\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>ISO 8871-5 Ampoule Elastomeric Closure Testing In the pharmaceutical industry, ensuring the integrity of packaging components such as elastomeric closures is critical to product safety and efficacy. ISO 8871-5 outlines the functional requirements and test methods for rubber stoppers used with parenteral containers, particularly vials and ampoules. This standard covers various test procedures including the [&hellip;]<\/p>","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-463","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ISO 8871-5 Ampoule Rubber Stopper Test - Penetrability, Leak Test<\/title>\n<meta name=\"description\" content=\"ISO 8871-5 testing for ampoule elastomeric closures. 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