{"id":49796,"date":"2026-03-17T09:33:34","date_gmt":"2026-03-17T09:33:34","guid":{"rendered":"https:\/\/skan.clients.ideeal.ch\/?post_type=services&#038;p=49796"},"modified":"2026-05-13T17:36:33","modified_gmt":"2026-05-13T15:36:33","slug":"smepac-isolator-containment-test","status":"publish","type":"services","link":"https:\/\/skan.com\/de\/services\/pharma\/sterility-assurance\/smepac-isolator-containment-test","title":{"rendered":"SMEPAC Isolator Containment Test"},"content":{"rendered":"    <section  class=\"section-feature-grid pt-default pb-default\">\r\n        <div class=\"container\">\r\n                            <header class=\"entry-header any-b0\">\r\n                                            <h5>Isolator Containment Test im \u00dcberblick<\/h5>\r\n                                                                <h2>International anerkanntes Testvorgehen<\/h2>\r\n                                    <\/header>\r\n                                        <ul class=\"feature-grid-list list-reset\">\r\n                                                                                                <li>\r\n                                <div class=\"feature-grid-item any-b0\">\r\n                                    <figure class=\"icon\" aria-hidden=\"true\">\r\n                                                                                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\"><rect x=\"0.5\" y=\"0.5\" width=\"23\" height=\"23\" rx=\"11.5\" fill=\"#E2ECF0\" stroke=\"#C5D9E1\"\/><path d=\"M7 11.7308L10.5 15.5L17 8.5\" stroke=\"#004682\" stroke-width=\"1.5\" stroke-linecap=\"square\"\/><\/svg>\r\n                                                                            <\/figure>\r\n                                                                            <h3>Gepr\u00fcfte CPT-Einhaltung<\/h3>\r\n                                                                                                                <p>Verifiziert, ob die Containment-Leistung den definierten CPT-Anforderungen (Containment Performance Target) gem\u00e4ss OEB-Risikostufen entspricht<\/p>\r\n                                                                    <\/div>\r\n                            <\/li>\r\n                                                                                                                        <li>\r\n                                <div class=\"feature-grid-item any-b0\">\r\n                                    <figure class=\"icon\" aria-hidden=\"true\">\r\n                                                                                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\"><rect x=\"0.5\" y=\"0.5\" width=\"23\" height=\"23\" rx=\"11.5\" fill=\"#E2ECF0\" stroke=\"#C5D9E1\"\/><path d=\"M7 11.7308L10.5 15.5L17 8.5\" stroke=\"#004682\" stroke-width=\"1.5\" stroke-linecap=\"square\"\/><\/svg>\r\n                                                                            <\/figure>\r\n                                                                            <h3>ISPE\u00ae-konform und validiert<\/h3>\r\n                                                                                                                <p>Durchf\u00fchrung nach international anerkanntem ISPE\u00ae Good Practice Guide<\/p>\r\n                                                                    <\/div>\r\n                            <\/li>\r\n                                                                                                                        <li>\r\n                                <div class=\"feature-grid-item any-b0\">\r\n                                    <figure class=\"icon\" aria-hidden=\"true\">\r\n                                                                                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\"><rect x=\"0.5\" y=\"0.5\" width=\"23\" height=\"23\" rx=\"11.5\" fill=\"#E2ECF0\" stroke=\"#C5D9E1\"\/><path d=\"M7 11.7308L10.5 15.5L17 8.5\" stroke=\"#004682\" stroke-width=\"1.5\" stroke-linecap=\"square\"\/><\/svg>\r\n                                                                            <\/figure>\r\n                                                                            <h3>H\u00f6here Prozesssicherheit<\/h3>\r\n                                                                                                                <p>Etablierung sicherer Prozesse gem\u00e4ss Containment-Level und Produkttoxizit\u00e4t<\/p>\r\n                                                                    <\/div>\r\n                            <\/li>\r\n                                                                                                                        <li>\r\n                                <div class=\"feature-grid-item any-b0\">\r\n                                    <figure class=\"icon\" aria-hidden=\"true\">\r\n                                                                                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\"><rect x=\"0.5\" y=\"0.5\" width=\"23\" height=\"23\" rx=\"11.5\" fill=\"#E2ECF0\" stroke=\"#C5D9E1\"\/><path d=\"M7 11.7308L10.5 15.5L17 8.5\" stroke=\"#004682\" stroke-width=\"1.5\" stroke-linecap=\"square\"\/><\/svg>\r\n                                                                            <\/figure>\r\n                                                                            <h3>Risikokontrolle<\/h3>\r\n                                                                                                                <p>Minimierung der Arbeitsplatzexposition und Verbesserung der Arbeitssicherheit<\/p>\r\n                                                                    <\/div>\r\n                            <\/li>\r\n                                                                                                                        <li>\r\n                                <div class=\"feature-grid-item any-b0\">\r\n                                    <figure class=\"icon\" aria-hidden=\"true\">\r\n                                                                                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\"><rect x=\"0.5\" y=\"0.5\" width=\"23\" height=\"23\" rx=\"11.5\" fill=\"#E2ECF0\" stroke=\"#C5D9E1\"\/><path d=\"M7 11.7308L10.5 15.5L17 8.5\" stroke=\"#004682\" stroke-width=\"1.5\" stroke-linecap=\"square\"\/><\/svg>\r\n                                                                            <\/figure>\r\n                                                                            <h3>Optimierte Risikobewertung<\/h3>\r\n                                                                                                                <p>Detaillierte Einblicke in die Containment-Performance Ihrer Anlagen<\/p>\r\n                                                                    <\/div>\r\n                            <\/li>\r\n                                                                                                                        <li>\r\n                                <div class=\"feature-grid-item any-b0\">\r\n                                    <figure class=\"icon\" aria-hidden=\"true\">\r\n                                                                                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\"><rect x=\"0.5\" y=\"0.5\" width=\"23\" height=\"23\" rx=\"11.5\" fill=\"#E2ECF0\" stroke=\"#C5D9E1\"\/><path d=\"M7 11.7308L10.5 15.5L17 8.5\" stroke=\"#004682\" stroke-width=\"1.5\" stroke-linecap=\"square\"\/><\/svg>\r\n                                                                            <\/figure>\r\n                                                                            <h3>Praxisnahe Empfehlungen<\/h3>\r\n                                                                                                                <p>Konkrete Handlungsempfehlungen zur Entscheidungsunterst\u00fctzung nach der Studie<\/p>\r\n                                                                    <\/div>\r\n                            <\/li>\r\n                                                                                                                        <li>\r\n                                <div class=\"feature-grid-item any-b0\">\r\n                                    <figure class=\"icon\" aria-hidden=\"true\">\r\n                                                                                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\"><rect x=\"0.5\" y=\"0.5\" width=\"23\" height=\"23\" rx=\"11.5\" fill=\"#E2ECF0\" stroke=\"#C5D9E1\"\/><path d=\"M7 11.7308L10.5 15.5L17 8.5\" stroke=\"#004682\" stroke-width=\"1.5\" stroke-linecap=\"square\"\/><\/svg>\r\n                                                                            <\/figure>\r\n                                                                            <h3>Wissenschaftliches Know-how<\/h3>\r\n                                                                                                                <p>Fundierte Bewertung auf Basis von SKANs Erfahrung in sterilen Fertigungsprozessen<\/p>\r\n                                                                    <\/div>\r\n                            <\/li>\r\n                                                                                                                        <li>\r\n                                <div class=\"feature-grid-item any-b0\">\r\n                                    <figure class=\"icon\" aria-hidden=\"true\">\r\n                                                                                    <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\"><rect x=\"0.5\" y=\"0.5\" width=\"23\" height=\"23\" rx=\"11.5\" fill=\"#E2ECF0\" stroke=\"#C5D9E1\"\/><path d=\"M7 11.7308L10.5 15.5L17 8.5\" stroke=\"#004682\" stroke-width=\"1.5\" stroke-linecap=\"square\"\/><\/svg>\r\n                                                                            <\/figure>\r\n                                                                            <h3>SKAN-Expertenwissen<\/h3>\r\n                                                                                                                <p>Zugriff auf tiefgreifende Isolator-Expertise und praxisnahe Testkonfigurationen<\/p>\r\n                                                                    <\/div>\r\n                            <\/li>\r\n                                                            <\/ul>\r\n                    <\/div>\r\n    <\/section>\r\n\r\n\n\n    <section  class=\"section-image-text pt-default pb-default reverse default\">\r\n        <div class=\"container\">\r\n            <div class=\"entry-grid\">\r\n                                    <div class=\"text\">\r\n                        <div class=\"text-inner\">\r\n                                                            <h5>Anwendung<\/h5>\r\n                                                                                        <h2>Standardisierte Messung der Partikelkonzentration f\u00fcr maximale Sicherheit<\/h2>\r\n                                                                                                                    <ul class=\"feature-list list-reset\">\r\n                                                                                                                                                                <li>\r\n                                                <div class=\"feature-item\">\r\n                                                                                                            <figure>\r\n                                                            <img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" src=\"https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/Biohazard.svg\" class=\"attachment-full size-full\" alt=\"\" \/>                                                        <\/figure>\r\n                                                                                                                                                                <div class=\"any-b0\">\r\n                                                            <h3>F\u00fcr Hersteller potenter Wirkstoffe<\/h3>\n<p>Bei der Herstellung hochwirksamer APIs m\u00fcssen strenge Expositionsgrenzwerte (OELs) eingehalten werden. Mit dem SMEPAC-Service wird die R\u00fcckhalteleistung von Isolatoren gepr\u00fcft, d. h. ob Ihre Anlagen die geforderten Sicherheitsstandards einhalten.<\/p>\n                                                        <\/div>\r\n                                                                                                    <\/div>\r\n                                            <\/li>\r\n                                                                                                                                                                                                        <li>\r\n                                                <div class=\"feature-item\">\r\n                                                                                                            <figure>\r\n                                                            <img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" src=\"https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/icon_formulierung.svg\" class=\"attachment-full size-full\" alt=\"\" \/>                                                        <\/figure>\r\n                                                                                                                                                                <div class=\"any-b0\">\r\n                                                            <h3>F\u00fcr die pharmazeutische Produktion und Abf\u00fcllung<\/h3>\n<p>In Produktionsumgebungen mit toxischen Substanzen ist die Kontrolle luftgetragener Partikel zentral. SMEPAC-Tests bewerten die Containment-F\u00e4higkeit von F\u00fclllinien, Transfer- oder Compounding-Isolatoren.<\/p>\n                                                        <\/div>\r\n                                                                                                    <\/div>\r\n                                            <\/li>\r\n                                                                                                                                                                                                        <li>\r\n                                                <div class=\"feature-item\">\r\n                                                                                                            <figure>\r\n                                                            <img loading=\"lazy\" decoding=\"async\" width=\"24\" height=\"24\" src=\"https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/Qualifizierung.svg\" class=\"attachment-full size-full\" alt=\"\" \/>                                                        <\/figure>\r\n                                                                                                                                                                <div class=\"any-b0\">\r\n                                                            <h3>F\u00fcr Qualit\u00e4ts- und Compliance-Teams<\/h3>\n<p>SMEPAC-Studien erm\u00f6glichen die Einordnung Ihrer Systeme in OEL- und OEB-Kategorien. So lassen sich Risikoprofile und Schutzmassnahmen pr\u00e4zise ableiten. Das hilft, Sicherheitsstrategien an der Produkttoxizit\u00e4t auszurichten.<\/p>\n                                                        <\/div>\r\n                                                                                                    <\/div>\r\n                                            <\/li>\r\n                                                                                                            <\/ul>\r\n                                                                                <\/div>\r\n                    <\/div>\r\n                                                    <div class=\"image\">\r\n                        <figure class=\"\">\r\n                                                            <img loading=\"lazy\" decoding=\"async\" width=\"1404\" height=\"1560\" src=\"https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smepac-isolator-containment-toxic-test.jpg\" class=\"attachment-full size-full\" alt=\"Zerbrochenes Glas mit leuchtendem Pulver verstreut\" srcset=\"https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smepac-isolator-containment-toxic-test.jpg 1404w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smepac-isolator-containment-toxic-test-270x300.jpg 270w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smepac-isolator-containment-toxic-test-922x1024.jpg 922w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smepac-isolator-containment-toxic-test-768x853.jpg 768w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smepac-isolator-containment-toxic-test-1382x1536.jpg 1382w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smepac-isolator-containment-toxic-test-357x397.jpg 357w\" sizes=\"auto, (max-width: 1404px) 100vw, 1404px\" \/>                                                    <\/figure>\r\n                    <\/div>\r\n                            <\/div>\r\n        <\/div>\r\n    <\/section>\r\n\n\n    <section  class=\"section-process-element pt-default pb-default\">\r\n        <div class=\"container\">\r\n                            <header class=\"entry-header any-b0\">\r\n                                            <h5>Prozess<\/h5>\r\n                                                                <h2>Ihr Weg zu verifiziertem Containment: Der SMEPAC-Prozess<\/h2>\r\n                                    <\/header>\r\n                                        <div class=\"swiper process-element-slider\">\r\n                    <button class=\"swiper-button-prev\" type=\"button\">\r\n                        <span class=\"accessibility\">Vorherige Folie<\/span>\r\n                        <svg aria-hidden=\"true\" width=\"22\" height=\"18\" viewBox=\"0 0 22 18\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"m9 17.003-8-8 8-8M1 9.003h21\" stroke=\"#004682\"\/><\/svg>\r\n                    <\/button>\r\n                    <ul class=\"swiper-wrapper list-reset\">\r\n                                                                                                                <li class=\"swiper-slide\">\r\n                                    <div class=\"process-element\">\r\n                                                                                    <div>\r\n                                                <span class=\"number\">1<\/span>\r\n                                            <\/div>\r\n                                                                                                                            <div class=\"any-b0\">\r\n                                                                                                    <h3>Prozessanalyse<\/h3>\r\n                                                                                                <p>Workshop zur Analyse Ihrer Prozesse und Definition einer passgenauen Studienstrategie.<\/p>\n                                            <\/div>\r\n                                                                            <\/div>\r\n                                <\/li>\r\n                                                                                                                                            <li class=\"swiper-slide\">\r\n                                    <div class=\"process-element\">\r\n                                                                                    <div>\r\n                                                <span class=\"number\">2<\/span>\r\n                                            <\/div>\r\n                                                                                                                            <div class=\"any-b0\">\r\n                                                                                                    <h3>Planung und Protokollerstellung<\/h3>\r\n                                                                                                <p>Erstellung eines genehmigten Testplans und eines detaillierten Testprotokolls mit allen Parametern.<\/p>\n                                            <\/div>\r\n                                                                            <\/div>\r\n                                <\/li>\r\n                                                                                                                                            <li class=\"swiper-slide\">\r\n                                    <div class=\"process-element\">\r\n                                                                                    <div>\r\n                                                <span class=\"number\">3<\/span>\r\n                                            <\/div>\r\n                                                                                                                            <div class=\"any-b0\">\r\n                                                                                                    <h3>Durchf\u00fchrung vor Ort<\/h3>\r\n                                                                                                <p>Simulation Ihres Prozesses mit Surrogatmaterial, Probenahme (Luft\/Oberfl\u00e4che) an kritischen Stellen, Analyse durch ein zertifiziertes Labor.<\/p>\n                                            <\/div>\r\n                                                                            <\/div>\r\n                                <\/li>\r\n                                                                                                                                            <li class=\"swiper-slide\">\r\n                                    <div class=\"process-element\">\r\n                                                                                    <div>\r\n                                                <span class=\"number\">4<\/span>\r\n                                            <\/div>\r\n                                                                                                                            <div class=\"any-b0\">\r\n                                                                                                    <h3>Ergebnisdokumentation und Analyse<\/h3>\r\n                                                                                                <p>Erstellung und Freigabe des vollst\u00e4ndigen Studienberichts, Vergleich der Messwerte mit Zielwerten, Bewertung der Containment-Leistung.<\/p>\n                                            <\/div>\r\n                                                                            <\/div>\r\n                                <\/li>\r\n                                                                                                                                            <li class=\"swiper-slide\">\r\n                                    <div class=\"process-element\">\r\n                                                                                    <div>\r\n                                                <span class=\"number\">5<\/span>\r\n                                            <\/div>\r\n                                                                                                                            <div class=\"any-b0\">\r\n                                                                                                    <h3>Ergebnisbesprechung<\/h3>\r\n                                                                                                <p>Detaillierte Vorstellung und Diskussion der Resultate sowie Kl\u00e4rung m\u00f6glicher Folgeaktionen oder weiterer Studien.<\/p>\n                                            <\/div>\r\n                                                                            <\/div>\r\n                                <\/li>\r\n                                                                        <\/ul>\r\n                    <button class=\"swiper-button-next\" type=\"button\">\r\n                        <span class=\"accessibility\">N\u00e4chste Folie<\/span>\r\n                        <svg aria-hidden=\"true\" width=\"22\" height=\"18\" viewBox=\"0 0 22 18\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"m13 17.003 8-8-8-8M21 9.003H0\" stroke=\"#004682\"\/><\/svg>\r\n                    <\/button>\r\n                    <nav class=\"swiper-pagination\"><\/nav>\r\n                <\/div>\r\n                    <\/div>\r\n    <\/section>\r\n\r\n\n\n    <section  class=\"section-image-text pt-default pb-default default\">\r\n        <div class=\"container\">\r\n            <div class=\"entry-grid\">\r\n                                    <div class=\"text\">\r\n                        <div class=\"text-inner\">\r\n                                                            <h5>Servicevorteile<\/h5>\r\n                                                                                        <h2>Ihre Investition in Sicherheit und Compliance<\/h2>\r\n                                                                                                                    <ul class=\"feature-list list-reset\">\r\n                                                                                                                                                                <li>\r\n                                                <div class=\"feature-item\">\r\n                                                                                                                                                                <div class=\"any-b0\">\r\n                                                            <h3>Gepr\u00fcfte OEB-Einhaltung<\/h3>\n<p>Kontrollierte Exposition, pr\u00e4zise Risikoprofile und definierte Schutzmassnahmen<\/p>\n                                                        <\/div>\r\n                                                                                                    <\/div>\r\n                                            <\/li>\r\n                                                                                                                                                                                                        <li>\r\n                                                <div class=\"feature-item\">\r\n                                                                                                                                                                <div class=\"any-b0\">\r\n                                                            <h3>Branchenstandard<\/h3>\n<p>Tests nach ISPE\u00ae Good Practice Guide f\u00fcr Containment-Leistung pharmazeutischer Anlagen<\/p>\n                                                        <\/div>\r\n                                                                                                    <\/div>\r\n                                            <\/li>\r\n                                                                                                                                                                                                        <li>\r\n                                                <div class=\"feature-item\">\r\n                                                                                                                                                                <div class=\"any-b0\">\r\n                                                            <h3>SKAN-Expertenwissen nutzen<\/h3>\n<p>Langj\u00e4hrige Erfahrung, fundierte Testplanung, Durchf\u00fchrung und Bewertung durch SKAN-Spezialistenteam<\/p>\n                                                        <\/div>\r\n                                                                                                    <\/div>\r\n                                            <\/li>\r\n                                                                                                            <\/ul>\r\n                                                                                <\/div>\r\n                    <\/div>\r\n                                                    <div class=\"image\">\r\n                        <figure class=\"\">\r\n                                                            <img loading=\"lazy\" decoding=\"async\" width=\"1404\" height=\"1560\" src=\"https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smecpac-containment-test.jpg\" class=\"attachment-full size-full\" alt=\"Tupfertest am Isolator in einem weissen Quadrat\" srcset=\"https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smecpac-containment-test.jpg 1404w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smecpac-containment-test-270x300.jpg 270w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smecpac-containment-test-922x1024.jpg 922w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smecpac-containment-test-768x853.jpg 768w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smecpac-containment-test-1382x1536.jpg 1382w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smecpac-containment-test-357x397.jpg 357w\" sizes=\"auto, (max-width: 1404px) 100vw, 1404px\" \/>                                                    <\/figure>\r\n                    <\/div>\r\n                            <\/div>\r\n        <\/div>\r\n    <\/section>\r\n\n\n    <section  class=\"section-tabs-technical-information pt-default pb-default\">\r\n        <div class=\"container\">\r\n                            <h2>Technische Spezifikationen<\/h2>\r\n                                        <ul class=\"site-tablist\" data-tabs role=\"tablist\">\r\n                                                                    <li>\r\n                            <a href=\"#tab-InkludierteLeistungen0block_03db2479aff9f9a9a8def4d7261514f4\" data-tabby-default>Inkludierte Leistungen<\/a>\r\n                        <\/li>\r\n                                                                    <li>\r\n                            <a href=\"#tab-Messmethoden1block_03db2479aff9f9a9a8def4d7261514f4\" >Messmethoden<\/a>\r\n                        <\/li>\r\n                                    <\/ul>\r\n                <div class=\"site-tab-content-wrap\">\r\n                                                                                                <div id=\"tab-InkludierteLeistungen0block_03db2479aff9f9a9a8def4d7261514f4\" class=\"tab-content any-b0\">\r\n                                                                                                    <ul class=\"technical-information-list list-reset\">\r\n                                                                                                                                                                                <li>\r\n                                                    <figure aria-hidden=\"true\">\r\n                                                                                                                    <svg width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><rect x=\".5\" y=\".5\" width=\"23\" height=\"23\" rx=\"11.5\" fill=\"#E2ECF0\" stroke=\"#C5D9E1\"\/><path d=\"m7 11.73 3.5 3.77 6.5-7\" stroke=\"#004682\" stroke-width=\"1.5\" stroke-linecap=\"square\"\/><\/svg>\r\n                                                                                                            <\/figure>\r\n                                                    <div class=\"any-b0\">\r\n                                                                                                                    <h5>Beratung<\/h5>\r\n                                                                                                                                                                            <p>Definition Studiendesign im Rahmen eines Strategie-Workshops\r\n<\/p>\r\n                                                                                                            <\/div>\r\n                                                <\/li>\r\n                                                                                                                                                                                                                            <li>\r\n                                                    <figure aria-hidden=\"true\">\r\n                                                                                                                    <svg width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><rect x=\".5\" y=\".5\" width=\"23\" height=\"23\" rx=\"11.5\" fill=\"#E2ECF0\" stroke=\"#C5D9E1\"\/><path d=\"m7 11.73 3.5 3.77 6.5-7\" stroke=\"#004682\" stroke-width=\"1.5\" stroke-linecap=\"square\"\/><\/svg>\r\n                                                                                                            <\/figure>\r\n                                                    <div class=\"any-b0\">\r\n                                                                                                                    <h5>Studie<\/h5>\r\n                                                                                                                                                                            <p>Massgeschneiderte Containment-Studie vor Ort<\/p>\r\n                                                                                                            <\/div>\r\n                                                <\/li>\r\n                                                                                                                                                                                                                            <li>\r\n                                                    <figure aria-hidden=\"true\">\r\n                                                                                                                    <svg width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><rect x=\".5\" y=\".5\" width=\"23\" height=\"23\" rx=\"11.5\" fill=\"#E2ECF0\" stroke=\"#C5D9E1\"\/><path d=\"m7 11.73 3.5 3.77 6.5-7\" stroke=\"#004682\" stroke-width=\"1.5\" stroke-linecap=\"square\"\/><\/svg>\r\n                                                                                                            <\/figure>\r\n                                                    <div class=\"any-b0\">\r\n                                                                                                                    <h5>Dokumentation<\/h5>\r\n                                                                                                                                                                            <p>Vollumf\u00e4nglicher Studienbericht<\/p>\r\n                                                                                                            <\/div>\r\n                                                <\/li>\r\n                                                                                                                        <\/ul>\r\n                                                            <\/div>\r\n                                                                                                                        <div id=\"tab-Messmethoden1block_03db2479aff9f9a9a8def4d7261514f4\" class=\"tab-content any-b0\">\r\n                                                                                                    <ul class=\"technical-information-list list-reset\">\r\n                                                                                                                                                                                <li>\r\n                                                    <figure aria-hidden=\"true\">\r\n                                                                                                                    <svg width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><rect x=\".5\" y=\".5\" width=\"23\" height=\"23\" rx=\"11.5\" fill=\"#E2ECF0\" stroke=\"#C5D9E1\"\/><path d=\"m7 11.73 3.5 3.77 6.5-7\" stroke=\"#004682\" stroke-width=\"1.5\" stroke-linecap=\"square\"\/><\/svg>\r\n                                                                                                            <\/figure>\r\n                                                    <div class=\"any-b0\">\r\n                                                                                                                    <h5>Luftkeimsammlung (Luftprobenahme)<\/h5>\r\n                                                                                                                                                                            <p>Erfassung luftgetragener Partikel an definierten Messpunkten ausserhalb des Isolators mittels personenbezogener oder station\u00e4rer Luftprobenahme w\u00e4hrend der Prozesssimulation<\/p>\r\n                                                                                                            <\/div>\r\n                                                <\/li>\r\n                                                                                                                                                                                                                            <li>\r\n                                                    <figure aria-hidden=\"true\">\r\n                                                                                                                    <svg width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><rect x=\".5\" y=\".5\" width=\"23\" height=\"23\" rx=\"11.5\" fill=\"#E2ECF0\" stroke=\"#C5D9E1\"\/><path d=\"m7 11.73 3.5 3.77 6.5-7\" stroke=\"#004682\" stroke-width=\"1.5\" stroke-linecap=\"square\"\/><\/svg>\r\n                                                                                                            <\/figure>\r\n                                                    <div class=\"any-b0\">\r\n                                                                                                                    <h5>Oberfl\u00e4chenprobenahme (Wischproben)<\/h5>\r\n                                                                                                                                                                            <p>Entnahme von Wischproben an kritischen Oberfl\u00e4chen rund um den Isolator, um m\u00f6gliche Partikelablagerungen des Surrogatmaterials zu bestimmen<\/p>\r\n                                                                                                            <\/div>\r\n                                                <\/li>\r\n                                                                                                                                                                                                                            <li>\r\n                                                    <figure aria-hidden=\"true\">\r\n                                                                                                                    <svg width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><rect x=\".5\" y=\".5\" width=\"23\" height=\"23\" rx=\"11.5\" fill=\"#E2ECF0\" stroke=\"#C5D9E1\"\/><path d=\"m7 11.73 3.5 3.77 6.5-7\" stroke=\"#004682\" stroke-width=\"1.5\" stroke-linecap=\"square\"\/><\/svg>\r\n                                                                                                            <\/figure>\r\n                                                    <div class=\"any-b0\">\r\n                                                                                                                    <h5>Quantitative Laboranalyse<\/h5>\r\n                                                                                                                                                                            <p>Bestimmung der Surrogatkonzentration in den Proben durch ein qualifiziertes externes Labor mittels validierter analytischer Methoden<\/p>\r\n                                                                                                            <\/div>\r\n                                                <\/li>\r\n                                                                                                                                                                                                                            <li>\r\n                                                    <figure aria-hidden=\"true\">\r\n                                                                                                                    <svg width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><rect x=\".5\" y=\".5\" width=\"23\" height=\"23\" rx=\"11.5\" fill=\"#E2ECF0\" stroke=\"#C5D9E1\"\/><path d=\"m7 11.73 3.5 3.77 6.5-7\" stroke=\"#004682\" stroke-width=\"1.5\" stroke-linecap=\"square\"\/><\/svg>\r\n                                                                                                            <\/figure>\r\n                                                    <div class=\"any-b0\">\r\n                                                                                                                    <h5>Bewertung der Messergebnisse<\/h5>\r\n                                                                                                                                                                            <p>Vergleich der gemessenen Konzentrationen mit definierten Ziel- bzw. Grenzwerten zur Bewertung der Containment-Leistung des Systems<\/p>\r\n                                                                                                            <\/div>\r\n                                                <\/li>\r\n                                                                                                                        <\/ul>\r\n                                                            <\/div>\r\n                                                            <\/div>\r\n                    <\/div>\r\n    <\/section>\r\n\n\n    <section  class=\"section-download-accordions pt-default pb-default\">\r\n        <div class=\"container\">\r\n            <div class=\"entry-grid\">\r\n                <div class=\"any-b0\">\r\n                                            <h2>H\u00e4ufige Fragen<\/h2>\r\n                                    <\/div>\r\n                                    <div>\r\n                                                    <ul class=\"site-accordion accordion list-reset\">\r\n                                                                                                                                                <li>\r\n                                            <button class=\"opener\" type=\"button\">\r\n                                                <span>Was ist eine SMEPAC-Studie?<\/span>\r\n                                                <span class=\"icon\" aria-hidden=\"true\"><\/span>\r\n                                            <\/button>\r\n                                                                                            <div class=\"slide any-b0 has-custom-list\">\r\n                                                    <p>SMEPAC steht f\u00fcr Standardized Measurement of Equipment Particulate Airborne Concentration. Es handelt sich um einen standardisierten Test gem\u00e4ss ISPE\u00ae Good Practice Guide, um die R\u00fcckhaltef\u00e4higkeit von Isolatoren gegen\u00fcber toxischen Partikeln zu bewerten.<\/p>\n                                                <\/div>\r\n                                                                                    <\/li>\r\n                                                                                                                                                                                    <li>\r\n                                            <button class=\"opener\" type=\"button\">\r\n                                                <span>Warum ist eine Containment-Pr\u00fcfung wichtig?<\/span>\r\n                                                <span class=\"icon\" aria-hidden=\"true\"><\/span>\r\n                                            <\/button>\r\n                                                                                            <div class=\"slide any-b0 has-custom-list\">\r\n                                                    <p>Sie sch\u00fctzt Mitarbeitende vor einer \u00fcberm\u00e4ssigen Exposition gegen\u00fcber potenten Substanzen, erm\u00f6glicht die Einstufung Ihrer Systeme gem\u00e4ss OEL\/OEB und stellt regulatorische Compliance sicher.<\/p>\n                                                <\/div>\r\n                                                                                    <\/li>\r\n                                                                                                                                                                                    <li>\r\n                                            <button class=\"opener\" type=\"button\">\r\n                                                <span>Welche Systeme k\u00f6nnen getestet werden?<\/span>\r\n                                                <span class=\"icon\" aria-hidden=\"true\"><\/span>\r\n                                            <\/button>\r\n                                                                                            <div class=\"slide any-b0 has-custom-list\">\r\n                                                    <p>Alle Isolatoren oder geschlossenen Barrieresysteme f\u00fcr die Verarbeitung potenter Produkte, z. B. aseptisch-toxische oder toxische Isolatoren, Abf\u00fclllinien, Materialtransfer- oder Compounding-Isolatoren.<\/p>\n                                                <\/div>\r\n                                                                                    <\/li>\r\n                                                                                                                                                                                    <li>\r\n                                            <button class=\"opener\" type=\"button\">\r\n                                                <span>Was passiert, wenn mein System die Anforderungen nicht erf\u00fcllt?<\/span>\r\n                                                <span class=\"icon\" aria-hidden=\"true\"><\/span>\r\n                                            <\/button>\r\n                                                                                            <div class=\"slide any-b0 has-custom-list\">\r\n                                                    <p>Die Messergebnisse werden mit definierten Zielwerten verglichen. Ergibt sich daraus eine unzureichende Containment-Leistung, besprechen wir mit Ihnen m\u00f6gliche weitere Tests oder Massnahmen.<\/p>\n                                                <\/div>\r\n                                                                                    <\/li>\r\n                                                                                                                                                                                    <li>\r\n                                            <button class=\"opener\" type=\"button\">\r\n                                                <span>Wann ist der richtige Zeitpunkt f\u00fcr eine SMEPAC-Studie?<\/span>\r\n                                                <span class=\"icon\" aria-hidden=\"true\"><\/span>\r\n                                            <\/button>\r\n                                                                                            <div class=\"slide any-b0 has-custom-list\">\r\n                                                    <p>In einer sp\u00e4ten Projektphase, wenn die Ausr\u00fcstung vollst\u00e4ndig aufgebaut ist und die IQ\/OQ-Qualifizierung abgeschlossen wurde. Dann ist ein realit\u00e4tsnaher Test m\u00f6glich.<\/p>\n                                                <\/div>\r\n                                                                                    <\/li>\r\n                                                                                                <\/ul>\r\n                                            <\/div>\r\n                            <\/div>\r\n        <\/div>\r\n    <\/section>\r\n\n\n    <section  class=\"section-service-teaser-slider pt-80 pb-default\">\r\n        <div class=\"container\">\r\n                            <div class=\"entry-header any-b0\">\r\n                    <h2>Passende Services<\/h2>\r\n                <\/div>\r\n                                                            <div class=\"swiper service-teaser-slider\">\r\n                        <button class=\"swiper-button-prev\" type=\"button\">\r\n                            <span class=\"accessibility\">Vorherige Folie<\/span>\r\n                 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class=\"tag-topic-list list-reset\">\r\n                                                                                                <li>\r\n                                <span class=\"tag-topic\">\r\n                                    Vor Ort                                <\/span>\r\n                            <\/li>\r\n                                                                                                                        <li>\r\n                                <span class=\"tag-topic\">\r\n                                    Bei SKAN                                <\/span>\r\n                            <\/li>\r\n                                                            <\/ul>\r\n                    <\/div>\r\n        <h3>Reinigungsstrategie<\/h3>\r\n                    <p>Wissenschaftlich fundierte Reinigungsstrategie vom Experten<\/p>\r\n                <span class=\"link\">\r\n            <span aria-hidden=\"true\"><\/span>\r\n            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class=\"tag-topic\">\r\n                                    Vor Ort                                <\/span>\r\n                            <\/li>\r\n                                                                                                                        <li>\r\n                                <span class=\"tag-topic\">\r\n                                    Bei SKAN                                <\/span>\r\n                            <\/li>\r\n                                                            <\/ul>\r\n                    <\/div>\r\n        <h3>Materialeignungstests<\/h3>\r\n                    <p>Pr\u00fcfung der Materialeignung f\u00fcr aseptische Umgebungen<\/p>\r\n                <span class=\"link\">\r\n            <span aria-hidden=\"true\"><\/span>\r\n            <span>Details<\/span>\r\n        <\/span>\r\n    <\/div>\r\n<\/a>                                <\/li>\r\n                                                            <li class=\"swiper-slide\">\r\n                                    <a class=\"icon-teaser-card adjustment\" href=\"https:\/\/skan.com\/de\/services\/pharma\/sterility-assurance\/zyklusentwicklung\">\r\n    <div class=\"inner\">\r\n        <div class=\"head\">\r\n                            <figure class=\"icon\" aria-hidden=\"true\">\r\n                    <img loading=\"lazy\" decoding=\"async\" width=\"96\" height=\"96\" src=\"https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/H2O2-Raumdekontamination.svg\" class=\"attachment-full size-full\" alt=\"\" \/>                <\/figure>\r\n                                        <ul class=\"tag-topic-list list-reset\">\r\n                                                                                                <li>\r\n                                <span class=\"tag-topic\">\r\n                                    Vor Ort                                <\/span>\r\n                            <\/li>\r\n                                                            <\/ul>\r\n                    <\/div>\r\n        <h3>Zyklusentwicklung<\/h3>\r\n                    <p>Ihr Schl\u00fcssel zu validierten Dekontaminationsprozessen<\/p>\r\n                <span class=\"link\">\r\n            <span aria-hidden=\"true\"><\/span>\r\n            <span>Details<\/span>\r\n        <\/span>\r\n    <\/div>\r\n<\/a>                                <\/li>\r\n                                                            <li class=\"swiper-slide\">\r\n                                    <a class=\"icon-teaser-card adjustment\" href=\"https:\/\/skan.com\/de\/services\/pharma\/sterility-assurance\/zyklustransfer-performance-test\">\r\n    <div class=\"inner\">\r\n        <div class=\"head\">\r\n                            <figure class=\"icon\" aria-hidden=\"true\">\r\n                    <img loading=\"lazy\" decoding=\"async\" width=\"1\" height=\"1\" src=\"https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/pikto-cycle-transfer-performance-tests.svg\" class=\"attachment-full size-full\" alt=\"\" \/>                <\/figure>\r\n                                        <ul class=\"tag-topic-list list-reset\">\r\n                                                                                                <li>\r\n                                <span class=\"tag-topic\">\r\n                                    Vor Ort                                <\/span>\r\n                            <\/li>\r\n                                                            <\/ul>\r\n                    <\/div>\r\n        <h3>Zyklustransfer und Performance-Test<\/h3>\r\n                    <p>Bew\u00e4hrte Zyklen sicher auf neue Isolatoren \u00fcbertragen und validieren<\/p>\r\n                <span class=\"link\">\r\n            <span aria-hidden=\"true\"><\/span>\r\n            <span>Details<\/span>\r\n        <\/span>\r\n    <\/div>\r\n<\/a>         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class=\"icon-teaser-card adjustment\" href=\"https:\/\/skan.com\/de\/services\/pharma\/sterility-assurance\/mikrobiologische-re-qualifizierung\">\r\n    <div class=\"inner\">\r\n        <div class=\"head\">\r\n                            <figure class=\"icon\" aria-hidden=\"true\">\r\n                    <img loading=\"lazy\" decoding=\"async\" width=\"1\" height=\"1\" src=\"https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/pikto-microbiological-re-qualification.svg\" class=\"attachment-full size-full\" alt=\"\" \/>                <\/figure>\r\n                                        <ul class=\"tag-topic-list list-reset\">\r\n                                                                                                <li>\r\n                                <span class=\"tag-topic\">\r\n                                    Vor Ort                                <\/span>\r\n                            <\/li>\r\n                                                            <\/ul>\r\n                    <\/div>\r\n        <h3>Mikrobiologische (Re-)Qualifizierung<\/h3>\r\n                    <p>Verl\u00e4sslicher Nachweis f\u00fcr dauerhaft wirksame Dekontaminationszyklen<\/p>\r\n                <span class=\"link\">\r\n            <span aria-hidden=\"true\"><\/span>\r\n            <span>Details<\/span>\r\n        <\/span>\r\n    <\/div>\r\n<\/a>                                <\/li>\r\n                                                            <li class=\"swiper-slide\">\r\n                                    <a class=\"icon-teaser-card adjustment\" href=\"https:\/\/skan.com\/de\/services\/pharma\/sterility-assurance\/dosimetrie\">\r\n    <div class=\"inner\">\r\n        <div class=\"head\">\r\n                            <figure class=\"icon\" aria-hidden=\"true\">\r\n                    <img loading=\"lazy\" decoding=\"async\" width=\"1\" height=\"1\" src=\"https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/pikto-dosimetry.svg\" class=\"attachment-full size-full\" alt=\"\" \/>                <\/figure>\r\n                                        <ul class=\"tag-topic-list list-reset\">\r\n                                                                                                <li>\r\n                                <span class=\"tag-topic\">\r\n                                    Vor Ort                                <\/span>\r\n                            <\/li>\r\n                                                                                                                        <li>\r\n                                <span class=\"tag-topic\">\r\n                                    Bei SKAN                                <\/span>\r\n                            <\/li>\r\n                                                            <\/ul>\r\n                    <\/div>\r\n        <h3>Dosimetrie<\/h3>\r\n                    <p>Verl\u00e4ssliche Dosispr\u00fcfung und Restgasanalyse f\u00fcr den ebeam<\/p>\r\n                <span class=\"link\">\r\n            <span aria-hidden=\"true\"><\/span>\r\n            <span>Details<\/span>\r\n        <\/span>\r\n    <\/div>\r\n<\/a>                                <\/li>\r\n                                                                                <\/ul>\r\n                        <button class=\"swiper-button-next\" type=\"button\">\r\n                            <span class=\"accessibility\">N\u00e4chste Folie<\/span>\r\n                            <svg aria-hidden=\"true\" width=\"22\" height=\"18\" viewBox=\"0 0 22 18\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"m13 17.003 8-8-8-8M21 9.003H0\" stroke=\"#004682\"\/><\/svg>\r\n                        <\/button>\r\n                        <nav class=\"swiper-pagination\"><\/nav>\r\n                    <\/div>\r\n                                    <\/div>\r\n    <\/section>\r\n","protected":false},"author":4,"featured_media":52293,"parent":0,"template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"services-category":[432,434,438,441],"class_list":["post-49796","services","type-services","status-publish","has-post-thumbnail","hentry","services-category-validierung","services-category-modernisierung","services-category-sterility-assurance","services-category-sicherheit-containment"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>SMEPAC Isolator Containment Test | SKAN<\/title>\n<meta name=\"description\" content=\"SMEPAC-Studien: Validierung der Isolator-Containment-Leistung nach den internationalen ISPE Guidelines f\u00fcr maximale Sicherheit.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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