{"id":1605,"date":"2023-08-22T10:21:33","date_gmt":"2023-08-22T02:21:33","guid":{"rendered":"http:\/\/www.orientfiltr.tech\/?page_id=1605"},"modified":"2024-02-21T16:53:55","modified_gmt":"2024-02-21T08:53:55","slug":"extractables-and-leachables-test","status":"publish","type":"page","link":"https:\/\/www.orientfiltr.com\/index.php\/extractables-and-leachables-test\/","title":{"rendered":"Extractables and Leachables Test"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1605\" class=\"elementor elementor-1605\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-33b798a8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"33b798a8\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-9f42244\" data-id=\"9f42244\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-64c46820 elementor-widget elementor-widget-heading\" data-id=\"64c46820\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Extractables and Leachables Test<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-78011a2b\" data-id=\"78011a2b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-70919295 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"70919295\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-1725d581\" data-id=\"1725d581\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-23e68a20 elementor-icon-list--layout-inline elementor-align-end elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"23e68a20\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items elementor-inline-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-inline-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.orientfiltr.com\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-map-marker-alt\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Home<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-inline-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.orientfiltr.com\/index.php\/validation-center\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-angle-right\"><\/i>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Validation Center<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-f77ee0a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f77ee0a\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-bd631fa\" data-id=\"bd631fa\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-90ac384 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"90ac384\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-518bdc39 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"518bdc39\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-177f7ccd\" data-id=\"177f7ccd\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-717e342b elementor-widget elementor-widget-heading\" data-id=\"717e342b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Extractables and Leachables Test<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-50e0b84b elementor-widget elementor-widget-text-editor\" data-id=\"50e0b84b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p class=\"Default\"><span lang=\"EN\" style=\"font-size: 11.5pt; color: #323232;\">Extractables : Refers to chemical constituents that may be extracted from contact surfaces through the application of simulated or more severe forces (e.g., solvent, temperature, or time). Determined under simulated solvents and &#8221; worst case &#8221; conditions. (Interpretation: selection of model solvent, sterilization condition parameters, maximum filtration temperature, longest contact time and other worst conditions.)<\/span><\/p>\n<p class=\"Default\"><span lang=\"EN\" style=\"font-size: 11.5pt; color: #323232;\">Leachables : Chemical substances and elements that, under actual process conditions, migrate from any product contact material or component into the process fluid and may be present in the final product. Leachables are usually a subset of extractables and may be reaction products or degradation products of extractables.<\/span><\/p>\n<p class=\"Default\"><b><span lang=\"EN\" style=\"font-size: 15.0pt; color: #f86d56;\">Main Point<\/span><\/b><\/p>\n<p class=\"Default\"><span lang=\"EN\" style=\"font-size: 11.5pt; color: #323232;\">1. Pseudomonas diminuta is the standard challenge organism for bacterial retention testing in sterile filtration validation. (Pseudomonas diminuta was selected as the standard challenge microorganism: a. It is a water-borne Gram-negative bacterium, which is widely representative of possible contaminating bacteria in the pharmaceutical production process; b. The size of the bacterium is very small, The diameter is about 0.3~0.4\u03bcm, and the length is 0.6~1.0\u03bcm; c. It is not pathogenic and can produce unicellular bacteria with reproducible size and shape relatively stably)<\/span><\/p>\n<p class=\"Default\"><span lang=\"EN\" style=\"font-size: 11.5pt; color: #323232;\">2. The microbial retention test usually includes three batches, at least one of which should be a filter membrane with low bubble point (low specification). (Interpretation: Among the three batches, two batches are randomly selected commercial normal specification filter membranes, and the third batch, the low bubble point filter membrane, is a specially produced filter membrane close to the bubble point limit. Membrane, which is manufactured with a slightly different process than normal specifications, represents the &#8220;worst case&#8221; for membrane filtration.)<\/span><\/p>\n<p class=\"Default\"><span lang=\"EN\" style=\"font-size: 11.5pt; color: #323232;\">3. Low bubble point requirement: within 10% of the standard bubble point value. (For example, assuming a filter, the standard bubble point value provided by the supplier is 50psi, and the bubble point of the low bubble point membrane is usually between 50-55psi. The lower the bubble point value, the more representative the worst condition.)<\/span><\/p>\n<p class=\"Default\"><span lang=\"EN\" style=\"font-size: 11.5pt; color: #323232;\">4. If the low bubble point filter membrane is not used in the verification, the bubble point value of the standard solution filter membrane\/core used in the actual production must be higher than the minimum bubble point of the filter membrane actually used in the verification test value.<\/span><\/p>\n<p class=\"Default\"><span lang=\"EN\" style=\"font-size: 11.5pt; color: #323232;\">5. Set up a 0.45um parallel control. (Interpretation: 0.45\u03bcm In order to exclude the influencing factors of the experimental bacteria, if the downstream of the 0.45\u03bcm filter is sterile, the experimental bacteria do not meet the requirements.)<\/span><\/p>\n<p class=\"Default\"><span lang=\"EN\" style=\"font-size: 11.5pt; color: #323232;\">6. As much as possible, challenge microorganisms should be directly inoculated in the drug for bacterial challenge.<\/span><\/p>\n<p class=\"Default\"><span lang=\"EN\" style=\"font-size: 11.5pt; color: #323232;\">7. If an alternative solution is used for testing, provide reasonable data and explanations.<\/span><\/p>\n<p class=\"Default\"><span lang=\"EN\" style=\"font-size: 11.5pt; color: #323232;\">8. For the same family of products, that is, products with the same components but different concentrations, the method of challenging the limit concentration can be used for verification. (Interpretation: For the bacterial challenge experiment, the influencing factors are more complicated, including the influence of the product on the membrane, and the influence of the product on the size and shape of the bacteria. Therefore, there are usually different concentrations of the same components in high, medium and low.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4fa72717 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"4fa72717\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-25 elementor-top-column elementor-element elementor-element-70393f1\" data-id=\"70393f1\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-61979e4a elementor-widget__width-initial elementor-widget elementor-widget-image\" data-id=\"61979e4a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"300\" height=\"72\" src=\"https:\/\/www.orientfiltr.com\/wp-content\/uploads\/2023\/07\/cropped-\uff08LOGO-1-e1690356111828-300x72.png\" class=\"attachment-medium size-medium wp-image-130\" alt=\"\" srcset=\"https:\/\/www.orientfiltr.com\/wp-content\/uploads\/2023\/07\/cropped-\uff08LOGO-1-e1690356111828-300x72.png 300w, https:\/\/www.orientfiltr.com\/wp-content\/uploads\/2023\/07\/cropped-\uff08LOGO-1-e1690356111828-1024x247.png 1024w, https:\/\/www.orientfiltr.com\/wp-content\/uploads\/2023\/07\/cropped-\uff08LOGO-1-e1690356111828-768x185.png 768w, https:\/\/www.orientfiltr.com\/wp-content\/uploads\/2023\/07\/cropped-\uff08LOGO-1-e1690356111828-1536x371.png 1536w, 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data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-76702a20\" data-id=\"76702a20\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2ed918e2 e-grid-align-left elementor-shape-rounded elementor-grid-0 elementor-widget elementor-widget-social-icons\" data-id=\"2ed918e2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"social-icons.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-social-icons-wrapper elementor-grid\" role=\"list\">\n\t\t\t\t\t\t\t<span class=\"elementor-grid-item\" role=\"listitem\">\n\t\t\t\t\t<a class=\"elementor-icon elementor-social-icon 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href=\"https:\/\/www.orientfiltr.com\/index.php\/industries\/\">Industries<\/a><\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7b38ae78 elementor-align-start elementor-widget__width-initial elementor-icon-list--layout-traditional elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"7b38ae78\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.orientfiltr.com\/index.php\/food-beverage\/\">\n\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Food &amp; Beverage<\/span>\n\t\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t<span 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