{"id":22,"date":"2020-02-03T13:30:08","date_gmt":"2020-02-03T13:30:08","guid":{"rendered":"https:\/\/www.almacgroup.com\/analytical-solid-state\/?page_id=22"},"modified":"2025-07-01T14:27:11","modified_gmt":"2025-07-01T13:27:11","slug":"stability-testing-storage","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/analytical-solid-state\/stability-testing-storage\/","title":{"rendered":"Stability Testing and Storage"},"content":{"rendered":"\n<h3 class=\"wp-block-heading\" id=\"h-offering-comprehensive-and-cost-effective-gmp-stability-testing-study-management-and-stability-storage-services-in-accordance-with-cgmp-and-ich-guidelines\">Offering comprehensive and cost-effective GMP stability testing, study management and stability storage services in accordance with cGMP and ICH guidelines<\/h3>\n\n\n\n<p>Stability testing is essential when developing a pharmaceutical product. Stability testing determines how well the drug product reacts when exposed to conditions such as heat, pH, humidity and radiation. It is critical for patient safety to understand how a drug product will modify over time and guidance is required on the storage and disposal of the product.<\/p>\n\n\n\n<p>Our all-inclusive stability service encompasses protocol design, analytical method transfer, study management, sample analysis and QA approved reporting, taking into account transport simulation and in-use stability programmes.<\/p>\n\n\n\n<p>Our UK, European, and US state-of-the-art, walk-in stability chambers provide 300m<sup>3<\/sup>&nbsp;of ICH-compliant, climatic storage facilities to satisfy all requirements.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>-80\u00b0C and -20\u00b0C freezers<\/li>\n\n\n\n<li>5\u00b0C refrigerated storage<\/li>\n\n\n\n<li>25\u00b0C\/60%RH long term stability storage<\/li>\n\n\n\n<li>30\u00b0C\/65%RH intermediate stability storage<\/li>\n\n\n\n<li>30\u00b0C\/75%RH climate zone IV<\/li>\n\n\n\n<li>40\u00b0C\/75%RH accelerated stability storage<\/li>\n\n\n\n<li>Photo-stability<\/li>\n<\/ul>\n\n\n\n<p>At any given time, our dedicated team supervises 350 or more stability programmes. From early phase material to validation and commercial batches, all conditions are continually monitored and employ back-up systems to ensure a secure and controlled environment.<\/p>\n\n\n\n<p>As part of our release testing activities, we also offer reference standard management which is a critical aspect of drug development to ensure there are no avoidable delays. Find out more <a href=\"\/analytical-solid-state\/pharmaceutical-drug-product-release-testing\/\">here<\/a>.<\/p>\n\n\n<!-- Accordions -->\n<section class=\"u-bg-white u-p-y4 t-theme-component-overwrite\" id=\"accordionBlock\">\n\t<div class=\"o-wrapper\">\n\t\t<div class=\"o-grid o-grid--center\">\n\t\t\t<div class=\"o-grid__item u-width-full u-align-center u-align-left@m\">\n\t\t\t\t\t\t\t\t\t<h2 class=\"u-line-height-140 u-a-center@s u-c-mid-grey\"><h3 style=\"text-align: left;\">ASAPPrime\u00ae<\/h3>\n<\/h2>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"u-c-mid-grey u-a-center@s\"><p style=\"text-align: left;\">At Almac, we offer Freethink Technologies ASAPprime\u00ae software to streamline our processes and accelerate your product pipeline as an add-on service to your drug development programme.<\/p>\n<p style=\"text-align: left;\">ASAP Prime\u00ae allows for rapid and accurate predictions of the stability and shelf life of pharmaceutical products. By using scientifically designed exposure conditions, the software forces the product to hit its stability limits, allowing for precise predictions of the product\u2019s long-term storage behaviour.<\/p>\n<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t<div class=\"u-m-t2\">\n\t\t\t\t\t<div class=\"c-accordion js-accordion\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<article id=\"item1\" class=\"c-accordion__item u-c-mid-grey accordion-1\">\n\t\t\t\t\t\t        <h4 class=\"c-accordion__title u-bg-white u-c-mid-grey js-accordionTarget-one\">What does this mean for your project?<\/h4>\n\t\t\t\t\t\t        <div class=\"c-accordion__content u-bg-white\">\n\t\t\t\t\t\t\t\t\t<div class=\"o-grid\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- if image is there then allow content to sit with it -->\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<!-- if not then content goes full width -->\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"o-grid__item u-width-full\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<div class=\"s-cms\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<ul>\n<li>Speed, efficiency and accuracy<\/li>\n<li style=\"text-align: left;\">Cost savings<\/li>\n<li style=\"text-align: left;\">Predictive modelling<\/li>\n<li style=\"text-align: left;\">Accelerated timeline<\/li>\n<li style=\"text-align: left;\">Complementary to traditional studies<\/li>\n<li style=\"text-align: left;\">Flexibility in study design<\/li>\n<li style=\"text-align: left;\">Risk-based development<\/li>\n<\/ul>\n\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<\/article>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t<\/div> <!-- \/c-tabs -->\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div> <!-- \/o-grid -->\n\t<\/div> <!-- \/o-wrapper -->\n<\/section>\n\n\n\t<article class=\"o-grid o-grid--full\">\n\n\t\t<div class=\"o-grid__item u-width-full u-m-t6 u-m-t4@m u-m-b4\">\n\t\t\t<h2 class=\"u-normal u-a-center\">Related Resources<\/h2>\n\t\t<\/div>\n\n\t\t<div class=\"u-flex u-flex-justify-center u-flex-wrap u-width-full c-news-panels__slider js-news-panels\">\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/wp-content\/uploads\/sites\/10\/2023\/10\/Almac-equipment-List-Analytical-Services.pdf\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img lazyload\" style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2021\/03\/4.jpeg&#039;)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">Equipment List<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">Analytical Equipment List<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/api-chemical-development\/spotlight-on-stability-api-and-drug-product-testing\/\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img lazyload\" style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2021\/04\/analytical-scaled.jpg&#039;)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">Article<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">Spotlight on stability: API and drug product testing<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/spotlight-on-stability-api-and-drug-product-testing-2\/\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img lazyload\" style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2021\/05\/api-scaled.jpg&#039;)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">Case Study<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">Spotlight on stability: API and drug product testing<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t\t\t<article class=\"u-width-1\/4 u-width-half@l u-width-full@m\">\n\n\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/library\/outsourcing-analytical-services-because-its-worth-it\/\">\n\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"c-news-panels u-a-center\">\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__img lazyload\" style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2021\/08\/SI-KC-image-1.png&#039;)\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-meta\">Article<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t\t\t<div class=\"c-news-panels__content u-width-full u-p-x2 u-p-y2 u-bg-white\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<p class=\"u-text-18 u-normal\">Outsourcing Analytical Services&#8230;because it&#8217;s worth it<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t<\/div>\n\t<\/article>\n\n\n<!-- <article id=\"related\">\n\t<div class=\"o-grid\">\n\t\t\t\t<div class=\"o-grid__item u-width-full u-a-center\">\n\t\t\t\t\t\t\t<h3 class=\"u-normal u-m-b4\">Related Resources<\/h3>\n\t\t\t\t\t<\/div>\n\t\n\t\t<div class=\"u-flex u-flex-justify-center u-flex-wrap u-width-full c-resources__slider js-resources-panels\">\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t<article class=\"c-resources__grid u-width-1\/4 u-width-half@l u-width-full@m\">\n\t\t\t\t\n\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/wp-content\/uploads\/sites\/10\/2023\/10\/Almac-equipment-List-Analytical-Services.pdf\" target=\"\">\n\t\t\t\t\t\t<div class=\"c-resources c-overlay__ u-a-center lazyload\" style=\"background-image:inherit;\" data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2021\/03\/4.jpeg&#039;)\">\n\t\t\t\t\t\t\t<div class=\"c-resources__gradient-inner\">\n\t\t\t\t\t\t\t\t<p class=\"c-resources__type u-text-small u-bold u-m-b1\">Equipment List<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"u-normal\">Analytical Equipment List<\/h3>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\n\t\t\t\t\t\t\t\t\t<article class=\"c-resources__grid u-width-1\/4 u-width-half@l u-width-full@m\">\n\t\t\t\t\n\t\t\t\t\t<a href=\"https:\/\/www.almacgroup.com\/knowledge\/api-chemical-development\/spotlight-on-stability-api-and-drug-product-testing\/\" target=\"\">\n\t\t\t\t\t\t<div class=\"c-resources c-overlay__ u-a-center lazyload\" style=\"background-image:inherit;\" 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data-bg-image=\"url(&#039;https:\/\/www.almacgroup.com\/analytical-solid-state\/wp-content\/uploads\/sites\/6\/2021\/08\/SI-KC-image-1.png&#039;)\">\n\t\t\t\t\t\t\t<div class=\"c-resources__gradient-inner\">\n\t\t\t\t\t\t\t\t<p class=\"c-resources__type u-text-small u-bold u-m-b1\">Article<\/p>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<h3 class=\"u-normal\">Outsourcing Analytical Services...because it's worth it<\/h3>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/article>\n\t\t\t\t\t<\/div>\n\t<\/div>\n<\/article> -->\n","protected":false},"excerpt":{"rendered":"<p>Offering comprehensive and cost-effective GMP stability testing, study management and stability storage services in accordance with cGMP and ICH guidelines Stability testing is essential when developing a pharmaceutical product. Stability testing determines how well the drug product reacts when exposed to conditions such as heat, pH, humidity and radiation. It is critical for patient safety [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-22","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.3.1 (Yoast SEO v26.3) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Stability Testing and Storage - Analytical &amp; Solid State Services<\/title>\n<meta name=\"description\" content=\"At any given time, our dedicated team supervises 350+ stability programmes. 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