{"id":4591,"date":"2026-10-23T11:30:18","date_gmt":"2026-10-23T11:30:18","guid":{"rendered":"https:\/\/nano-test.de\/?p=4591"},"modified":"2026-10-23T11:30:18","modified_gmt":"2026-10-23T11:30:18","slug":"pharmazeutischer-sterilitaetstest-validierung","status":"publish","type":"post","link":"https:\/\/nano-test.de\/en\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/","title":{"rendered":"Pharmaceutical Sterility Test | validation"},"content":{"rendered":"<h1><span style=\"color: #000000;\">GLP sterility testing for pharmaceutical products: methods, validation and nano-test solutions<\/span><\/h1>\n<p><span style=\"color: #000000;\">Sterility testing is a crucial microbiological analysis to determine whether microorganisms living in sterile pharmaceutical products are present. In injection preparations, eye drops, infusion solutions, biological products and sterile medical devices, this test represents the last safety barrier for patient safety. lead sepsis.<\/span><\/p>\n<p><span style=\"color: #000000;\">Sterility tests conducted in the context of Good Laboratory Practice (GLP) ensure that the results are reliable, reproducible and acceptable to the regulatory authorities. In this article, we will cover the basic methods of pharmaceutical GLP sterility testing, validation requirements and the accredited services of Nano-Test in this area.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p>\n<h2><span style=\"color: #000000;\">What is a sterility test and why does it have to be carried out within the framework of GLP?<\/span><\/h2>\n<p><span style=\"color: #000000;\">A sterility test is performed to check the effectiveness of the product's sterilization process and to demonstrate that the final product does not contain live microorganisms. However, a sterility test alone does not guarantee that a batch is sterile; This guarantee is primarily guaranteed by the validation of the sterilization process or the aseptic manufacturing process. The pharmacopoeias expressly point out: The test does not replace the process validation, but supports it[Reference:0].<\/span><\/p>\n<p><span style=\"color: #000000;\">It is imperative to carry out sterility tests within the framework of the GLP for the following reasons:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Datenzuverl\u00e4ssigkeit:<\/strong> Die GLP legt strenge Vorschriften in Bezug auf Personalschulung, Kalibrierung der Ger\u00e4te, Standardarbeitsanweisungen (SOP) und Datenintegrit\u00e4t (ALCOA+-Prinzipien) fest.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Beh\u00f6rdliche Anerkennung:<\/strong> Beh\u00f6rden wie die FDA, die EMA und die T\u0130TCK verlangen bei Zulassungsantr\u00e4gen GLP-konforme Sterilit\u00e4tspr\u00fcfberichte.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Dokumentation aseptischer Bedingungen:<\/strong> Es muss nachgewiesen werden, dass der Test unter aseptischen Bedingungen durchgef\u00fchrt wurde und die Umgebungskontrollen regelm\u00e4\u00dfig \u00fcberwacht wurden[reference:2].<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Methods for sterility testing<\/span><\/h2>\n<p><span style=\"color: #000000;\">Arzneib\u00fccher (Ph. Eur. 2.6.1, USP &lt;71&gt;, JP) definieren zwei grundlegende Methoden f\u00fcr die Sterilit\u00e4tspr\u00fcfung: <strong>Membrane filtration<\/strong> and <strong>direkte Inokulation<\/strong>. Die Wahl der Methode h\u00e4ngt von der Art des Produkts und seinen physikalisch-chemischen Eigenschaften ab.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<h3><span style=\"color: #000000;\">1. Membrane Filtration Method<\/span><\/h3>\n<p><span style=\"color: #000000;\">If the quality of the product allows filtration, the membrane filtration process is the preferred method[Reference:3]. In this process, the product is passed through a membrane filter with a maximum pore size of 0.45 \u00b5m; Microorganisms are retained on the filter, then the filter is transferred to a suitable nutrient medium and incubated.<\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>Areas of application:<\/strong> W\u00e4ssrige L\u00f6sungen, alkoholhaltige oder \u00f6lhaltige Pr\u00e4parate, Produkte, die mit w\u00e4ssrigen oder \u00f6lhaltigen L\u00f6sungsmitteln mischbar sind.<\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>Bei antimikrobieller Aktivit\u00e4t:<\/strong> Wenn das Produkt antimikrobielle Eigenschaften aufweist, wird die Membran mindestens dreimal gewaschen; der Waschzyklus darf maximal f\u00fcnf Waschg\u00e4nge \u00e0 100 ml pro Filter umfassen.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<h3><span style=\"color: #000000;\">2. Direct Inoculation Procedures<\/span><\/h3>\n<p><span style=\"color: #000000;\">In cases where membrane filtration is not suitable (e.g., non-filterable, viscous or particle-containing products), the direct inoculation method is used. In this process, the product is transferred directly to the nutrient medium[Reference:7]. It is suitable for products without antimicrobial activity or those in which this activity can be eliminated by dilution or inactivation.<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- H3-Unter&#252;berschrift --><\/span><\/p>\n<h3><span style=\"color: #000000;\">3. Nutrient Media Used<\/span><\/h3>\n<p><span style=\"color: #000000;\">The sterility test uses two basic culture media[Reference:9]:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Fluid Thioglycollate Medium (FTM):<\/strong> Es ist in erster Linie f\u00fcr anaerobe Bakterien konzipiert, weist jedoch auch aerobe Bakterien nach.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Soybean-Casein Digest Medium (SCDM):<\/strong> Es eignet sich sowohl zur Kultivierung von Pilzen als auch von aeroben Bakterien.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\">Incubation Conditions: for FTM 3 days at 32.5 \u00b1 2.5 \u00b0C (in the aptitude test) or 14 days (in routine testing); For SCDM 5 days at 22.5 \u00b1 2.5 \u00b0C (suitability) or 14 days (routine).<\/span><\/p>\n<p><span style=\"color: #000000;\"><!-- Tabellenanfang --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Comparison of sterility test procedures<\/span><\/h2>\n<p><span style=\"color: #000000;\">The following table summarizes the two basic sterility test methods:<\/span><\/p>\n<table>\n<thead>\n<tr>\n<th><span style=\"color: #000000;\">Act<\/span><\/th>\n<th><span style=\"color: #000000;\">Principle<\/span><\/th>\n<th><span style=\"color: #000000;\">Suitable product types<\/span><\/th>\n<th><span style=\"color: #000000;\">Use in antimicrobial products<\/span><\/th>\n<th><span style=\"color: #000000;\">Advantages<\/span><\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Membrane filtration<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">The product is passed through a 0.45 \u00b5m filter; Microorganisms are retained in the filter and transferred to the nutrient medium.<\/span><\/td>\n<td><span style=\"color: #000000;\">Aqueous, alcoholic and oily solutions; filterable products.<\/span><\/td>\n<td><span style=\"color: #000000;\">The membrane is rinsed at least three times (max. 5 \u00d7 100 ml).<\/span><\/td>\n<td><span style=\"color: #000000;\">Preferred method; wide range of applications.<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"color: #000000;\"><strong>Direct inoculation<\/strong><\/span><\/td>\n<td><span style=\"color: #000000;\">The product is transferred directly to the nutrient medium.<\/span><\/td>\n<td><span style=\"color: #000000;\">Non-filterable, viscous, particle-containing products.<\/span><\/td>\n<td><span style=\"color: #000000;\">The antimicrobial effect is eliminated by dilution or inactivation.<\/span><\/td>\n<td><span style=\"color: #000000;\">Alternative in cases where membrane filtration is not suitable.<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"color: #000000;\"><!-- Ende der Tabelle --> <!-- H2-&#220;berschrift --><\/span><\/p>\n<h2><span style=\"color: #000000;\">Validation of method suitability: The foundation stone of the sterility test<\/span><\/h2>\n<p><span style=\"color: #000000;\">Ein Sterilit\u00e4tstest ist nur dann g\u00fcltig, wenn nicht nur die richtige Methode ausgew\u00e4hlt wird, sondern auch nachgewiesen wird, dass diese Methode f\u00fcr die Produktmatrix geeignet ist. <strong>Diese als \u201eMethodeneignungspr\u00fcfung\u201c (method suitability test)<\/strong> bezeichnete Validierung best\u00e4tigt, dass die antimikrobielle Aktivit\u00e4t des Produkts unter den Testbedingungen ausreichend unterdr\u00fcckt wird.<\/span><\/p>\n<p><span style=\"color: #000000;\">Validation must be carried out in the following cases:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\">If a new product is subjected to a sterility test,<\/span><\/li>\n<li><span style=\"color: #000000;\">If changes are made to the test conditions,<\/span><\/li>\n<li><span style=\"color: #000000;\">When the composition or manufacturing technology of the product changes.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\">In the validation test, the antimicrobial activity of the product is evaluated by observing whether the test strains (maximum 100 cFU) multiply in the presence of the product or not. If the test strains do not multiply in the presence of the product, this means that antimicrobial activity has not been canceled and validation must be repeated under modified test conditions.<\/span><\/p>\n<div class=\"note\"><span style=\"color: #000000;\"><strong>Wichtig:<\/strong> Der Sterilit\u00e4tstest muss unter aseptischen Bedingungen (Laminar-Flow-Kabine, Reinraum oder Isolator der Klasse A) durchgef\u00fchrt werden. Die Arbeitsumgebung muss im Hinblick auf die GMP- und GLP-Konformit\u00e4t regelm\u00e4\u00dfig \u00fcberwacht werden.<\/span><\/div>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift: Nano-Test --><\/span><\/p>\n<h2><span style=\"color: #000000;\">GLP compliant sterility test services with nano test<\/span><\/h2>\n<p><span style=\"color: #000000;\">Die Gew\u00e4hrleistung der Sterilit\u00e4t Ihrer pharmazeutischen Produkte h\u00e4ngt nicht nur von der richtigen Testmethode ab, sondern auch davon, dass dieser Test in einem akkreditierten Labor gem\u00e4\u00df den GLP-Grunds\u00e4tzen und auf nachpr\u00fcfbare Weise durchgef\u00fchrt wird. <strong>Nano-Test<\/strong> ist mit seinen umfassenden mikrobiologischen Dienstleistungen in diesem Bereich ein zuverl\u00e4ssiger L\u00f6sungspartner f\u00fcr die pharmazeutische Industrie.<\/span><\/p>\n<div class=\"highlight\">\n<h3><span style=\"color: #000000;\">Nano-Test \u2013 Performance Description<\/span><\/h3>\n<p><span style=\"color: #000000;\">Nano-Test bietet <strong>GLP-konforme Sterilit\u00e4tstests (Sterility Test)<\/strong> f\u00fcr pharmazeutische Produkte an. Unsere Analysen werden in voller \u00dcbereinstimmung mit den Normen <strong>Ph. Eur. 2.6.1, USP &lt;71&gt; und ISO 11737-2:2019<\/strong> durchgef\u00fchrt[reference:15].<\/span><\/p>\n<p><span style=\"color: #000000;\">Our service portfolio:<\/span><\/p>\n<ul>\n<li><span style=\"color: #000000;\"><strong>Membranfiltrationsverfahren:<\/strong> Das bevorzugte Verfahren f\u00fcr filtrierbare Produkte; bei antimikrobiellen Produkten mit geeigneten Waschprotokollen.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Direktinokulationsverfahren:<\/strong> Alternatives Verfahren f\u00fcr nicht filtrierbare Produkte; Beseitigung der antimikrobiellen Aktivit\u00e4t durch Verd\u00fcnnung oder Inaktivierung.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Validierung der Methodeneignung:<\/strong> Bewertung der antimikrobiellen Aktivit\u00e4t speziell f\u00fcr Ihre Produktmatrix und Nachweis der Methodeneignung.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Qualit\u00e4tskontrolle der N\u00e4hrmedien:<\/strong> Best\u00e4tigung der wachstumsf\u00f6rdernden Eigenschaften der N\u00e4hrmedien mittels Growth-Promotion-Test.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Negativkontrolle:<\/strong> Gleichzeitige Durchf\u00fchrung geeigneter Negativkontrollen in jeder Testreihe.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Berichterstattung:<\/strong> GLP-konforme, auditierte und von den Aufsichtsbeh\u00f6rden akzeptierte Berichte.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\">All of our work is carried out under aseptic conditions, with data integrity (Alcoa+ principles) being guaranteed.<\/span><\/p>\n<\/div>\n<h3><span style=\"color: #000000;\">Advantages of the Nano Test sterility test:<\/span><\/h3>\n<ul>\n<li><span style=\"color: #000000;\"><strong>GLP-Akkreditierung:<\/strong> Mikrobiologielabor mit OECD-GLP-Konformit\u00e4tserkl\u00e4rung.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Pharmakop\u00f6e-Konformit\u00e4t:<\/strong> Vollst\u00e4ndige Konformit\u00e4t mit den Standards Ph. Eur. 2.6.1, USP &lt;71&gt; und ISO 11737-2.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Kompetenz in zwei Methoden:<\/strong> Sowohl Membranfiltration als auch Direktinokulation.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Validierungsunterst\u00fctzung:<\/strong> Nachweis der Validit\u00e4t der Pr\u00fcfung durch eine auf Ihr Produkt zugeschnittene Methodenvalidierung.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Schnelle Berichterstellung:<\/strong> Ergebnisse bei Standard-Sterilit\u00e4tstests innerhalb von 3\u20135 Werktagen nach der Inkubation.<\/span><\/li>\n<li><span style=\"color: #000000;\"><strong>Fachkundiges Team:<\/strong> Ein Team mit Erfahrung in pharmazeutischer Mikrobiologie und GLP-Validierung.<\/span><\/li>\n<\/ul>\n<p><span style=\"color: #000000;\"><!-- H2-&#220;berschrift: Ergebnis --><\/span><\/p>\n<p><span style=\"color: #000000;\">The sterility test for pharmaceutical products is the final control authority for patient safety. Choosing the right method (membrane filtration or direct inoculation), the complete execution of method validation validation and the execution of the test under aseptic conditions according to the GLP principles are essential for the validity of the results and the official recognition.<\/span><\/p>\n<p><span style=\"color: #000000;\">With its pharmacopeia-compliant infrastructure, its GLP accreditation and its specialist staff, Nano-Test comprehensively meets the requirements of the pharmaceutical manufacturers for sterility tests. Collaborate with Nano-Test to document the sterility safety of your products and speed up your approval process.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>GLP-Sterilit\u00e4tspr\u00fcfung bei pharmazeutischen Produkten: Methoden, Validierung und Nano-Test-L\u00f6sungen Die Sterilit\u00e4tspr\u00fcfung ist eine entscheidende mikrobiologische Analyse, mit der festgestellt wird, ob in als steril deklarierten pharmazeutischen Produkten lebende Mikroorganismen vorhanden sind. Bei Injektionspr\u00e4paraten, Augentropfen, Infusionsl\u00f6sungen, biologischen Produkten und sterilen Medizinprodukten stellt dieser Test die letzte Sicherheitsbarriere f\u00fcr die Patientensicherheit dar. Das Vorhandensein lebender Mikroorganismen in einem \u2026 <a href=\"https:\/\/nano-test.de\/en\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>Pharmazeutischer Sterilit\u00e4tstest | Validierung\u201c&gt;Continue reading <span class=\"screen-reader-text\">Pharmaceutical Sterility Test | validation<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":4592,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[6],"tags":[],"class_list":["post-4591","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pharmazeutischer Sterilit\u00e4tstest | Validierung | Nano-Test\u00ae<\/title>\n<meta name=\"description\" content=\"Sterilit\u00e4tstest von pharmazeutischen Produkten im Rahmen der GLP: Membranfiltration und Direktinokulation, Validierung der Methodeneignung, Anforderungen gem\u00e4\u00df Ph. Eur. 2.6.1 und USP . GLP-akkreditierte mikrobiologische Dienstleistungen von Nano-Test.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharmazeutischer Sterilit\u00e4tstest | Validierung | Nano-Test\u00ae\" \/>\n<meta property=\"og:description\" content=\"Sterilit\u00e4tstest von pharmazeutischen Produkten im Rahmen der GLP: Membranfiltration und Direktinokulation, Validierung der Methodeneignung, Anforderungen gem\u00e4\u00df Ph. Eur. 2.6.1 und USP . GLP-akkreditierte mikrobiologische Dienstleistungen von Nano-Test.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/\" \/>\n<meta property=\"og:site_name\" content=\"Nano-Test\u00ae\" \/>\n<meta property=\"article:published_time\" content=\"2026-10-23T11:30:18+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/nano-test.de\/wp-content\/uploads\/2026\/10\/Pharmazeutischer-Sterilitaetstest-Validierung.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"750\" \/>\n\t<meta property=\"og:image:height\" content=\"450\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"Sultan Culum\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Sultan Culum\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/2026\\\/10\\\/23\\\/pharmazeutischer-sterilitaetstest-validierung\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/2026\\\/10\\\/23\\\/pharmazeutischer-sterilitaetstest-validierung\\\/\"},\"author\":{\"name\":\"Sultan Culum\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/#\\\/schema\\\/person\\\/e873a4aee4023b424d94f10e41a12670\"},\"headline\":\"Pharmazeutischer Sterilit\u00e4tstest | Validierung\",\"datePublished\":\"2026-10-23T11:30:18+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/2026\\\/10\\\/23\\\/pharmazeutischer-sterilitaetstest-validierung\\\/\"},\"wordCount\":1270,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/2026\\\/10\\\/23\\\/pharmazeutischer-sterilitaetstest-validierung\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/nano-test.de\\\/wp-content\\\/uploads\\\/2026\\\/10\\\/Pharmazeutischer-Sterilitaetstest-Validierung.webp\",\"articleSection\":[\"Pharma\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/nano-test.de\\\/2026\\\/10\\\/23\\\/pharmazeutischer-sterilitaetstest-validierung\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/2026\\\/10\\\/23\\\/pharmazeutischer-sterilitaetstest-validierung\\\/\",\"url\":\"https:\\\/\\\/nano-test.de\\\/2026\\\/10\\\/23\\\/pharmazeutischer-sterilitaetstest-validierung\\\/\",\"name\":\"Pharmazeutischer Sterilit\u00e4tstest | Validierung | Nano-Test\u00ae\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/2026\\\/10\\\/23\\\/pharmazeutischer-sterilitaetstest-validierung\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/2026\\\/10\\\/23\\\/pharmazeutischer-sterilitaetstest-validierung\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/nano-test.de\\\/wp-content\\\/uploads\\\/2026\\\/10\\\/Pharmazeutischer-Sterilitaetstest-Validierung.webp\",\"datePublished\":\"2026-10-23T11:30:18+00:00\",\"description\":\"Sterilit\u00e4tstest von pharmazeutischen Produkten im Rahmen der GLP: Membranfiltration und Direktinokulation, Validierung der Methodeneignung, Anforderungen gem\u00e4\u00df Ph. Eur. 2.6.1 und USP . GLP-akkreditierte mikrobiologische Dienstleistungen von Nano-Test.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/2026\\\/10\\\/23\\\/pharmazeutischer-sterilitaetstest-validierung\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/nano-test.de\\\/2026\\\/10\\\/23\\\/pharmazeutischer-sterilitaetstest-validierung\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/2026\\\/10\\\/23\\\/pharmazeutischer-sterilitaetstest-validierung\\\/#primaryimage\",\"url\":\"https:\\\/\\\/nano-test.de\\\/wp-content\\\/uploads\\\/2026\\\/10\\\/Pharmazeutischer-Sterilitaetstest-Validierung.webp\",\"contentUrl\":\"https:\\\/\\\/nano-test.de\\\/wp-content\\\/uploads\\\/2026\\\/10\\\/Pharmazeutischer-Sterilitaetstest-Validierung.webp\",\"width\":750,\"height\":450},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/2026\\\/10\\\/23\\\/pharmazeutischer-sterilitaetstest-validierung\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/nano-test.de\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Pharmazeutischer Sterilit\u00e4tstest | Validierung\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/#website\",\"url\":\"https:\\\/\\\/nano-test.de\\\/\",\"name\":\"NANO-TEST\u00ae\",\"description\":\"Laboranalysen, Testservices, Pr\u00fcflabor &amp; Qualit\u00e4tskontrollen in Deutschland\",\"publisher\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/nano-test.de\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/#organization\",\"name\":\"NANO-TEST\u00ae\",\"url\":\"https:\\\/\\\/nano-test.de\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/nano-test.de\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/Nanotest-Logo-NT-scaled.png\",\"contentUrl\":\"https:\\\/\\\/nano-test.de\\\/wp-content\\\/uploads\\\/2026\\\/03\\\/Nanotest-Logo-NT-scaled.png\",\"width\":2510,\"height\":2560,\"caption\":\"NANO-TEST\u00ae\"},\"image\":{\"@id\":\"https:\\\/\\\/nano-test.de\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/nano-test.de\\\/#\\\/schema\\\/person\\\/e873a4aee4023b424d94f10e41a12670\",\"name\":\"Sultan Culum\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/ef47288e2a0dc3ff55e71e172f39c9c82ffbf55bad226f89d1aaa823e517a73b?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/ef47288e2a0dc3ff55e71e172f39c9c82ffbf55bad226f89d1aaa823e517a73b?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/ef47288e2a0dc3ff55e71e172f39c9c82ffbf55bad226f89d1aaa823e517a73b?s=96&d=mm&r=g\",\"caption\":\"Sultan Culum\"},\"sameAs\":[\"https:\\\/\\\/nano-test.de\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Pharmaceutical Sterility Test | Validation | Nano-Test\u00ae","description":"Sterility test of pharmaceutical products within the framework of GLP: membrane filtration and direct inoculation, validation of method suitability, requirements according to Ph. Eur. 2.6.1 and USP . GLP-accredited microbiological services from Nano-Test.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/","og_locale":"en_US","og_type":"article","og_title":"Pharmazeutischer Sterilit\u00e4tstest | Validierung | Nano-Test\u00ae","og_description":"Sterilit\u00e4tstest von pharmazeutischen Produkten im Rahmen der GLP: Membranfiltration und Direktinokulation, Validierung der Methodeneignung, Anforderungen gem\u00e4\u00df Ph. Eur. 2.6.1 und USP . GLP-akkreditierte mikrobiologische Dienstleistungen von Nano-Test.","og_url":"https:\/\/nano-test.de\/en\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/","og_site_name":"Nano-Test\u00ae","article_published_time":"2026-10-23T11:30:18+00:00","og_image":[{"width":750,"height":450,"url":"https:\/\/nano-test.de\/wp-content\/uploads\/2026\/10\/Pharmazeutischer-Sterilitaetstest-Validierung.webp","type":"image\/webp"}],"author":"Sultan Culum","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Sultan Culum","Est. reading time":"7 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/#article","isPartOf":{"@id":"https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/"},"author":{"name":"Sultan Culum","@id":"https:\/\/nano-test.de\/#\/schema\/person\/e873a4aee4023b424d94f10e41a12670"},"headline":"Pharmazeutischer Sterilit\u00e4tstest | Validierung","datePublished":"2026-10-23T11:30:18+00:00","mainEntityOfPage":{"@id":"https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/"},"wordCount":1270,"commentCount":0,"publisher":{"@id":"https:\/\/nano-test.de\/#organization"},"image":{"@id":"https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/#primaryimage"},"thumbnailUrl":"https:\/\/nano-test.de\/wp-content\/uploads\/2026\/10\/Pharmazeutischer-Sterilitaetstest-Validierung.webp","articleSection":["Pharma"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/","url":"https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/","name":"Pharmaceutical Sterility Test | Validation | Nano-Test\u00ae","isPartOf":{"@id":"https:\/\/nano-test.de\/#website"},"primaryImageOfPage":{"@id":"https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/#primaryimage"},"image":{"@id":"https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/#primaryimage"},"thumbnailUrl":"https:\/\/nano-test.de\/wp-content\/uploads\/2026\/10\/Pharmazeutischer-Sterilitaetstest-Validierung.webp","datePublished":"2026-10-23T11:30:18+00:00","description":"Sterility test of pharmaceutical products within the framework of GLP: membrane filtration and direct inoculation, validation of method suitability, requirements according to Ph. Eur. 2.6.1 and USP . GLP-accredited microbiological services from Nano-Test.","breadcrumb":{"@id":"https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/#primaryimage","url":"https:\/\/nano-test.de\/wp-content\/uploads\/2026\/10\/Pharmazeutischer-Sterilitaetstest-Validierung.webp","contentUrl":"https:\/\/nano-test.de\/wp-content\/uploads\/2026\/10\/Pharmazeutischer-Sterilitaetstest-Validierung.webp","width":750,"height":450},{"@type":"BreadcrumbList","@id":"https:\/\/nano-test.de\/2026\/10\/23\/pharmazeutischer-sterilitaetstest-validierung\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/nano-test.de\/"},{"@type":"ListItem","position":2,"name":"Pharmaceutical Sterility Test | validation"}]},{"@type":"WebSite","@id":"https:\/\/nano-test.de\/#website","url":"https:\/\/nano-test.de\/","name":"NANO-TEST\u00ae","description":"Laboratory analyses, testing services, testing laboratories and quality control in Germany","publisher":{"@id":"https:\/\/nano-test.de\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/nano-test.de\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/nano-test.de\/#organization","name":"NANO-TEST\u00ae","url":"https:\/\/nano-test.de\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/nano-test.de\/#\/schema\/logo\/image\/","url":"https:\/\/nano-test.de\/wp-content\/uploads\/2026\/03\/Nanotest-Logo-NT-scaled.png","contentUrl":"https:\/\/nano-test.de\/wp-content\/uploads\/2026\/03\/Nanotest-Logo-NT-scaled.png","width":2510,"height":2560,"caption":"NANO-TEST\u00ae"},"image":{"@id":"https:\/\/nano-test.de\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/nano-test.de\/#\/schema\/person\/e873a4aee4023b424d94f10e41a12670","name":"Sultan Culum","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/ef47288e2a0dc3ff55e71e172f39c9c82ffbf55bad226f89d1aaa823e517a73b?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/ef47288e2a0dc3ff55e71e172f39c9c82ffbf55bad226f89d1aaa823e517a73b?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/ef47288e2a0dc3ff55e71e172f39c9c82ffbf55bad226f89d1aaa823e517a73b?s=96&d=mm&r=g","caption":"Sultan Culum"},"sameAs":["https:\/\/nano-test.de"]}]}},"_links":{"self":[{"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/posts\/4591","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/comments?post=4591"}],"version-history":[{"count":0,"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/posts\/4591\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/media\/4592"}],"wp:attachment":[{"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/media?parent=4591"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/categories?post=4591"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nano-test.de\/wp-json\/wp\/v2\/tags?post=4591"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}