{"id":52106,"date":"2026-03-17T09:33:34","date_gmt":"2026-03-17T08:33:34","guid":{"rendered":"https:\/\/skan.clients.ideeal.ch\/?post_type=services&#038;p=52106"},"modified":"2026-05-13T17:36:52","modified_gmt":"2026-05-13T15:36:52","slug":"smepac-containment-testing-for-isolators-ispe-compliant-performance-validation","status":"publish","type":"services","link":"https:\/\/skan.com\/en\/services\/pharma\/sterility-assurance\/smepac-containment-testing-isolators","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 at a glance<\/h5>\r\n                                                                <h2>Internationally recognized testing procedure<\/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>Verified CPT compliance<\/h3>\r\n                                                                                                                <p>Verifies whether the containment performance meets the defined CPT (Containment Performance Target) requirements in accordance with OEB risk levels\r\n<\/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-compliant and validated<\/h3>\r\n                                                                                                                <p>Conducted according to the internationally recognized ISPE\u00ae Good Practice Guide\r\n<\/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>Higher process reliability<\/h3>\r\n                                                                                                                <p>Establishes safe processes based on containment level and product toxicity\r\n<\/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>Risk control<\/h3>\r\n                                                                                                                <p>Minimizes occupational exposure and improves workplace safety\r\n<\/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>Optimized risk assessment<\/h3>\r\n                                                                                                                <p>Detailed insights into the containment performance of your systems\r\n<\/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>Practical recommendations<\/h3>\r\n                                                                                                                <p>Concrete recommendations for action to support decision-making after the study\r\n<\/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>Scientific know-how<\/h3>\r\n                                                                                                                <p>Well-founded evaluation based on SKAN\u2019s experience in sterile manufacturing processes\r\n<\/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 expert knowledge<\/h3>\r\n                                                                                                                <p>Access to in-depth isolator expertise and practice-oriented test setups\r\n<\/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>Application<\/h5>\r\n                                                                                        <h2>Standardized measurement of particle concentration for maximum safety<\/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>For manufacturers of highly potent APIs<\/h3>\n<p>During the manufacture of highly potent APIs, strict occupational exposure limits (OELs) must be maintained. The SMEPAC service evaluates the containment performance of isolators, i.e., whether your systems meet the required safety standards.<\/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>For pharmaceutical production and filling<\/h3>\n<p>In production environments with toxic substances, controlling airborne particles is essential. SMEPAC tests assess the containment capability of filling lines, transfer isolators, or compounding isolators.<\/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>For quality and compliance teams<\/h3>\n<p>SMEPAC studies enable classification of your systems into OEL and OEB categories. This allows risk profiles and protective measures to be derived with precision. It supports aligning safety strategies with product toxicity.<\/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>Process<\/h5>\r\n                                                                <h2>Your path to verified containment: the SMEPAC process<\/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\">Previous slide<\/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>Process analysis<\/h3>\r\n                                                                                                <p>Workshop to analyze your processes and define a tailored study strategy.<\/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>Planning and protocol development<\/h3>\r\n                                                                                                <p>Preparation of an approved test plan and a detailed protocol with all parameters.<\/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>On-site execution<\/h3>\r\n                                                                                                <p>Simulation of your process using surrogate material, air, and surface sampling at critical points, and analysis by a certified laboratory.<\/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>Results documentation and evaluation<\/h3>\r\n                                                                                                <p>Creation and release of the full study report, comparison of results with target values, and assessment of containment performance.<\/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>Results review<\/h3>\r\n                                                                                                <p>Detailed presentation and discussion of results, plus clarification of potential next steps or further studies.<\/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\">Next slide<\/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>Service highlights<\/h5>\r\n                                                                                        <h2>Your investment in safety and 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>Verified OEB compliance<\/h3>\n<p>Controlled exposure, precise risk profiles, and defined protective measures.<\/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>Industry standard<\/h3>\n<p>Testing in accordance with the ISPE\u00ae Good Practice Guide for containment performance of pharmaceutical equipment.<\/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>Leveraging SKAN expert knowledge<\/h3>\n<p>Years of experience, well-founded test planning, execution, and assessment by the SKAN specialist team.<\/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=\"1394\" src=\"https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smecpac-containment-test-e1778665905181.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-e1778665905181.jpg 1404w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smecpac-containment-test-e1778665905181-300x298.jpg 300w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smecpac-containment-test-e1778665905181-1024x1017.jpg 1024w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smecpac-containment-test-e1778665905181-150x150.jpg 150w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smecpac-containment-test-e1778665905181-768x763.jpg 768w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smecpac-containment-test-e1778665905181-50x50.jpg 50w, https:\/\/skan.com\/wp-content\/uploads\/2026\/03\/smecpac-containment-test-e1778665905181-357x354.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>Technical specifications<\/h2>\r\n                                        <ul class=\"site-tablist\" data-tabs role=\"tablist\">\r\n                                                                    <li>\r\n                            <a href=\"#tab-Includedservices0block_f3d52ce8630bf418b59891f2b1104945\" data-tabby-default>Included services<\/a>\r\n                        <\/li>\r\n                                                                    <li>\r\n                            <a href=\"#tab-Measurementmethods1block_f3d52ce8630bf418b59891f2b1104945\" >Measurement methods<\/a>\r\n                        <\/li>\r\n                                    <\/ul>\r\n                <div class=\"site-tab-content-wrap\">\r\n                                                                                                <div id=\"tab-Includedservices0block_f3d52ce8630bf418b59891f2b1104945\" 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>Consulting<\/h5>\r\n                                                                                                                                                                            <p>Definition of study design during a strategy workshop<\/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>Study<\/h5>\r\n                                                                                                                                                                            <p>Customized on-site containment study<\/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>Documentation<\/h5>\r\n                                                                                                                                                                            <p>Comprehensive study report<\/p>\r\n                                                                                                            <\/div>\r\n                                                <\/li>\r\n                                                                                                                        <\/ul>\r\n                                                            <\/div>\r\n                                                                                                                        <div id=\"tab-Measurementmethods1block_f3d52ce8630bf418b59891f2b1104945\" 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>Airborne particle sampling (air sampling)<\/h5>\r\n                                                                                                                                                                            <p>Collection of airborne particles at defined measurement points outside the isolator using personal or stationary air sampling during process simulation<\/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>Surface sampling (swab samples)<\/h5>\r\n                                                                                                                                                                            <p>Collection of swab samples from critical surfaces around the isolator to determine possible particle deposits of the surrogate material<\/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 laboratory analysis<\/h5>\r\n                                                                                                                                                                            <p>Determination of the surrogate concentration in the samples by a qualified external laboratory using validated analytical methods<\/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>Evaluation of measurement results<\/h5>\r\n                                                                                                                                                                            <p>Comparison of the measured concentrations with defined target or limit values to evaluate the containment performance of the system\u2003<\/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>FAQs<\/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>What is a SMEPAC study?<\/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 stands for <em>Standardized Measurement of Equipment Particulate Airborne Concentration<\/em>. It is a standardized test following the ISPE\u00ae Good Practice Guide to assess isolator containment performance against toxic particles.<\/p>\n                                                <\/div>\r\n                                                                                    <\/li>\r\n                                                                                                                                                                                    <li>\r\n                                            <button class=\"opener\" type=\"button\">\r\n                                                <span>Why is containment testing important?<\/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>It protects personnel from excessive exposure to potent substances, enables classification of your systems according to OEL\/OEB, and ensures regulatory compliance.<\/p>\n                                                <\/div>\r\n                                                                                    <\/li>\r\n                                                                                                                                                                                    <li>\r\n                                            <button class=\"opener\" type=\"button\">\r\n                                                <span>What systems can be tested?<\/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>All isolators or closed barrier systems for the processing of potent products, e.g., aseptic-toxic or toxic isolators, filling lines, material transfer or compounding isolators.<\/p>\n                                                <\/div>\r\n                                                                                    <\/li>\r\n                                                                                                                                                                                    <li>\r\n                                            <button class=\"opener\" type=\"button\">\r\n                                                <span>What happens if my system does not meet the requirements?<\/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>The measuring results are compared to defined target values. If this reveals insufficient containment performance, we will discuss possible follow-up tests or measures.<\/p>\n                                                <\/div>\r\n                                                                                    <\/li>\r\n                                                                                                                                                                                    <li>\r\n                                            <button class=\"opener\" type=\"button\">\r\n                                                <span>When is the right time for a SMEPAC study?<\/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 the late project phase, once the equipment is fully set up and IQ\/OQ qualification is complete. At that point, a realistic test is possible.<\/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>Related 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\">Previous slide<\/span>\r\n                          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<h3>Cycle transfer and performance test<\/h3>\r\n                    <p>Safely transfer and validate proven cycles to new isolators<\/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\/en\/services\/pharma\/betrieb\/material-compatibility-tests\">\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-compatibility-tests.svg\" class=\"attachment-full size-full\" alt=\"\" \/>                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<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\/en\/services\/pharma\/sterility-assurance\/cleaning-strategy\">\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\/Clean.svg\" class=\"attachment-full size-full\" alt=\"\" \/>                <\/figure>\r\n                                        <ul class=\"tag-topic-list list-reset\">\r\n                                                                                                <li>\r\n                     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       <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-h2o2-residue-check.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                                    At SKAN                                <\/span>\r\n                            <\/li>\r\n                                                                                                                        <li>\r\n                                <span class=\"tag-topic\">\r\n                                    On-site                                <\/span>\r\n                            <\/li>\r\n                                                            <\/ul>\r\n                    <\/div>\r\n        <h3>H\u2082O\u2082 residue check<\/h3>\r\n                    <p>Identify risks posed by H\u2082O\u2082 residues early<\/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\/en\/services\/pharma\/sterility-assurance\/microbiological-re-qualification\">\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                                    On-site                                <\/span>\r\n                            <\/li>\r\n                                                            <\/ul>\r\n                    <\/div>\r\n        <h3>Microbiological (re-)qualification<\/h3>\r\n                    <p>Reliable proof of permanently effective decontamination cycles<\/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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