{"id":509,"date":"2021-09-16T06:46:55","date_gmt":"2021-09-16T06:46:55","guid":{"rendered":"http:\/\/boracdmo.com\/?page_id=509"},"modified":"2026-03-16T23:02:30","modified_gmt":"2026-03-16T23:02:30","slug":"stability-testing-storage","status":"publish","type":"page","link":"https:\/\/boracdmo.com\/stability-testing-storage\/","title":{"rendered":"Stability Testing and Storage"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"509\" class=\"elementor elementor-509\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a490b0d e-flex e-con-boxed e-con e-parent\" data-id=\"a490b0d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-decb8c5 elementor-widget elementor-widget-heading\" data-id=\"decb8c5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Looking for a trusted partner to bring your breakthrough drug successfully to the market?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f0f7268 elementor-widget elementor-widget-text-editor\" data-id=\"f0f7268\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<div class=\"et_pb_module et_pb_text et_pb_text_2 et_pb_text_align_left et_pb_bg_layout_light\"><div class=\"et_pb_text_inner\"><p>Reliable and consistent stability testing is a prerequisite to collect valuable data about drug product quality variations over time under a variety of environmental conditions including temperature, humidity, and light exposure.<\/p><\/div><\/div><div class=\"et_pb_module et_pb_text et_pb_text_3 et_pb_text_align_left et_pb_bg_layout_light\"><div class=\"et_pb_text_inner\"><p>At Bora, we use state-of-the-art ESI and Hsinron stability chambers equipped with an environmental monitoring system that continuously monitors the temperature and humidity, and automatically reports any deviations through visible and audible alarms. Our stability testing program, managed by a Labware LIMS or SAP system, is configured to avoid sampling errors at each time point and can easily trend temperature and humidity.<\/p><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9769ece e-flex e-con-boxed e-con e-parent\" data-id=\"9769ece\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-49195bb elementor-widget elementor-widget-heading\" data-id=\"49195bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Storage systems and capacity\n<\/h2>\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3fb51e4 e-con-full e-flex e-con e-child\" data-id=\"3fb51e4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-3639c50 e-con-full e-flex e-con e-child\" data-id=\"3639c50\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ddbe59d elementor-widget elementor-widget-text-editor\" data-id=\"ddbe59d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>We have redundant chambers for our 25\u00b0C\/60% RH, 30\u00b0C\/65%RH and 40\u00b0C\/75% RH conditions.\u00a0 All stability chambers are backed up with a diesel powdered generator.<\/p><p>We offer customized freeze\/thaw temperature cycling with temperature ranging from 5\u00b0C to 40\u00b0C and humidity ranging from ambient to 75% RH.\u00a0 We also can support in-use stability and shipping studies.<\/p><p>We have a photo-stability chamber which provides visible and UV exposure, meeting the requirements for Option 1 per ICH Q1B.<\/p><p>All stability chambers have limited access by key card and are locked at all times.\u00a0 Stability chambers are monitored 24 hours a day and building is staffed 24\/7.<\/p><p>Statistical analysis per ICH Q1E can be completed upon request.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-90bb258 e-con-full e-flex e-con e-child\" data-id=\"90bb258\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a74fdfe elementor-widget elementor-widget-text-editor\" data-id=\"a74fdfe\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p>Bora\u2019s analytical laboratories are equipped with multiple stability chambers including walk-in and standalone chambers that maintain a range of ICH conditions as well as custom conditions. Our stability chambers have capacity to store routine and overage samples and can be set at different temperatures, humidity, and durations to meet varied customer stability program requirements.<\/p><p>Our stability storage capabilities include:<\/p><ul><li>5\u02daC\/Ambient humidity<\/li><li>25\u02daC\/40% RH<\/li><li>25\u02daC\/60% RH<\/li><li>30\u02daC\/65% RH<\/li><li>30\u00b0C\/75% RH<\/li><li>40\u02daC\/25% RH<\/li><li>40\u02daC\/75% RH<\/li><li>50\u02daC\/ambient humidity<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Looking for a trusted partner to bring your breakthrough drug successfully to the market? Reliable and consistent stability testing is a prerequisite to collect valuable data about drug product quality variations over time under a variety of environmental conditions including temperature, humidity, and light exposure. At Bora, we use state-of-the-art ESI and Hsinron stability chambers [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":14,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"content-type":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-509","page","type-page","status-publish","hentry"],"aioseo_notices":[],"acf":[],"_links":{"self":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/pages\/509","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/comments?post=509"}],"version-history":[{"count":42,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/pages\/509\/revisions"}],"predecessor-version":[{"id":987500167,"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/pages\/509\/revisions\/987500167"}],"wp:attachment":[{"href":"https:\/\/boracdmo.com\/en\/wp-json\/wp\/v2\/media?parent=509"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}