{"id":15471,"date":"2025-04-04T14:23:19","date_gmt":"2025-04-04T12:23:19","guid":{"rendered":"https:\/\/www.rjl-microanalytic.de\/?p=15471"},"modified":"2025-12-18T15:15:57","modified_gmt":"2025-12-18T14:15:57","slug":"fremdpartikel-in-arzneimittelflaschen","status":"publish","type":"post","link":"https:\/\/www.rjl-microanalytic.de\/en\/fremdpartikel-in-arzneimittelflaschen\/","title":{"rendered":"Foreign Particles in Medical Vials"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"15471\" class=\"elementor elementor-15471\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7934927 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7934927\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f3cf1dc\" data-id=\"f3cf1dc\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-72522b7 elementor-widget elementor-widget-text-editor\" data-id=\"72522b7\" data-element_type=\"widget\" data-e-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\tSince the publication of the <a class=\"unterstrichen\" href=\"https:\/\/www.vdi.de\/richtlinien\/details\/vdi-2083-blatt-21-reinraumtechnik-reinheit-von-medizinprodukten-im-herstellungsprozess\">VDI 2083 sheet 21,<\/a> we observe an rising demand for foreign particle analysis in medical and pharmaceutical products <a  class=\"unterstrichen\" href=\"https:\/\/www.rjl-microanalytic.de\/en\/analysenservice-mit-iso-17025-akkreditierung\/\">our accredited testing laboratory<\/a> In addition to the traditional analysis of inorganic particles (metals, glass, etc.), organic particles are increasingly gaining focus. Recently, we determined for a customer whether and to what extent the rubber stopper used to seal a medication bottle generates particles when pierced with a syringe to withdraw the medication. During quality control, our customer discovered unknown foreign particles in their product through visual inspection and subsequently contacted us. Using FT-IR (Fourier Transform Infrared Spectroscopy), we were able to clearly determine that the foreign particle was from the rubber stopper.\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-27e44f9 elementor-widget elementor-widget-image\" data-id=\"27e44f9\" data-element_type=\"widget\" data-e-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 fetchpriority=\"high\" decoding=\"async\" width=\"1586\" height=\"580\" src=\"https:\/\/www.rjl-microanalytic.de\/wp-content\/uploads\/Bild2.png\" class=\"attachment-full size-full wp-image-15476\" alt=\"\" srcset=\"https:\/\/www.rjl-microanalytic.de\/wp-content\/uploads\/Bild2.png 1586w, https:\/\/www.rjl-microanalytic.de\/wp-content\/uploads\/Bild2-300x110.png 300w, https:\/\/www.rjl-microanalytic.de\/wp-content\/uploads\/Bild2-1024x374.png 1024w, https:\/\/www.rjl-microanalytic.de\/wp-content\/uploads\/Bild2-768x281.png 768w, https:\/\/www.rjl-microanalytic.de\/wp-content\/uploads\/Bild2-1536x562.png 1536w, https:\/\/www.rjl-microanalytic.de\/wp-content\/uploads\/Bild2-18x7.png 18w\" sizes=\"(max-width: 1586px) 100vw, 1586px\" \/>\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 class=\"elementor-element elementor-element-b5a7ac7 elementor-widget elementor-widget-text-editor\" data-id=\"b5a7ac7\" data-element_type=\"widget\" data-e-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\tThe customer was surprised that particles of several hundred micrometers could be created when piercing the stopper and wanted to statistically investigate the process. Since FT-IR, as a classic analytical method for determining organic substances, cannot be automated and is therefore only applicable to individual particles, we specifically analyzed the issue by SEM-EDX, using the <a  class=\"unterstrichen\" href=\"https:\/\/www.rjl-microanalytic.de\/en\/instrumente\/thermo-phenom-particlex-sem-edx-partikelanalyse-cleanliness-gsr-steel-inclusions-powders\/\">Phenom ParticleX<\/a>.\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<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t<div class=\"elementor-element elementor-element-0dc5d89 e-flex e-con-boxed e-con e-parent\" data-id=\"0dc5d89\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2db3a00 elementor-widget elementor-widget-image\" data-id=\"2db3a00\" data-element_type=\"widget\" data-e-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=\"800\" height=\"343\" src=\"https:\/\/www.rjl-microanalytic.de\/wp-content\/uploads\/Table-1-1024x439.png\" class=\"attachment-large size-large wp-image-15490\" alt=\"\" srcset=\"https:\/\/www.rjl-microanalytic.de\/wp-content\/uploads\/Table-1-1024x439.png 1024w, https:\/\/www.rjl-microanalytic.de\/wp-content\/uploads\/Table-1-300x129.png 300w, https:\/\/www.rjl-microanalytic.de\/wp-content\/uploads\/Table-1-768x329.png 768w, https:\/\/www.rjl-microanalytic.de\/wp-content\/uploads\/Table-1-1536x659.png 1536w, https:\/\/www.rjl-microanalytic.de\/wp-content\/uploads\/Table-1-18x8.png 18w, https:\/\/www.rjl-microanalytic.de\/wp-content\/uploads\/Table-1.png 1903w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\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 class=\"elementor-element elementor-element-30d20da elementor-widget elementor-widget-text-editor\" data-id=\"30d20da\" data-element_type=\"widget\" data-e-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>Over 80% of the foreign particles in a batch size of 250 medical vial were identified as rubber stoppers. Various syringe geometries and stopper materials will now be tested, and their suitability will be confirmed by statistically analyzing the foreign particles.<\/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-f58b982 elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"f58b982\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/en\/analysenservice-mit-iso-17025-akkreditierung\/sem-edx-identifikation-partikelverunreinigungen\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-info-circle\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Learn more about automatic particle analysis<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/en\/company\/kontakt\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-info-circle\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Get in touch with us<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\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\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>We recently determined for an analytical client whether and to what extent the rubber stopper used to seal a medication bottle generates particles when pierced with a syringe to withdraw the medication. The client was surprised that piercing the stopper can generate particles measuring several hundred micrometers and wanted to statistically investigate the process.<\/p>","protected":false},"author":1,"featured_media":15875,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9,11,12],"tags":[14,22,32,68,38,39,41,43,44,45,49,50],"class_list":["post-15471","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-innovative-analytik","category-analyse-technische-sauberkeit","category-elektronenmikroskopie-sem-edx","tag-bauteilsauberkeit","tag-iso-16232","tag-partikelanalyse","tag-prueflabor","tag-restschmutz","tag-restschmutzanalyse","tag-roentgenelementanalyse","tag-sauberkeitsanalyse","tag-sauberkeitspruefung","tag-sem-edx","tag-technische-sauberkeit","tag-vda-19"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.rjl-microanalytic.de\/en\/wp-json\/wp\/v2\/posts\/15471","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.rjl-microanalytic.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.rjl-microanalytic.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.rjl-microanalytic.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.rjl-microanalytic.de\/en\/wp-json\/wp\/v2\/comments?post=15471"}],"version-history":[{"count":26,"href":"https:\/\/www.rjl-microanalytic.de\/en\/wp-json\/wp\/v2\/posts\/15471\/revisions"}],"predecessor-version":[{"id":15873,"href":"https:\/\/www.rjl-microanalytic.de\/en\/wp-json\/wp\/v2\/posts\/15471\/revisions\/15873"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.rjl-microanalytic.de\/en\/wp-json\/wp\/v2\/media\/15875"}],"wp:attachment":[{"href":"https:\/\/www.rjl-microanalytic.de\/en\/wp-json\/wp\/v2\/media?parent=15471"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.rjl-microanalytic.de\/en\/wp-json\/wp\/v2\/categories?post=15471"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.rjl-microanalytic.de\/en\/wp-json\/wp\/v2\/tags?post=15471"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}