Being an essential component of pharmaceutical development, stability studies allow the evaluation of product stability under the influence of various environmental conditions. These include temperature, humidity and light, simulating different climatic zones from around the world. The data from such studies can be used to establish recommended storage conditions, retest periods, and shelf life.
ALS offers quality focused testing and proactively seeks to form long-term, mutually beneficial relationships. Our clients are accustomed to receiving high quality data, technical support and open communication. The collaborative approach is underpinned by project and client managers, skilled and qualified client service teams, access to technical experts and a management team committed to service delivery. Performing efficiently & ethically, ALS is ready to support the healthcare industries with trustworthy and reliable QC services.
ALS offers ICH stability storage and testing programs for a wide range of API’s, pharmaceuticals, biopharmaceuticals, medical devices, chemicals, dietary supplements and cosmetics, whether required for initial product registration and/or Product Quality Review (PQR). Our walk-in stability chambers meet GMP regulations and can be utilized for both long-term and short-term shelf life studies. All rooms are monitored in real time and our monitoring systems are fully validated and compliant with 21 CFR Part 11 requirements.
Our facilities operate emergency back-up facilities on site, allowing business continuity and complete peace of mind. In addition, all ALS sites operate at least one back-up room or cabinet that is mapped at all temperatures. We can provide a solution tailored to your requirements - storage only or full storage plus testing. Samples can be stored and scheduled for testing or shipped under controlled conditions to your chosen location at each time point or as required.
|Zone||Climate||Long Term Condition||Humidity|
|I||Temperate||21ºC ± 2ºC||40% RH ± 5% RH|
|II||Mediterranean / subtropical||25ºC ± 2ºC||60% RH ± 5% RH|
|III||Hot dry||30ºC ± 2ºC||35% RH ± 5% RH|
|IV||Hot humid / tropical||30ºC ± 2ºC||65% RH ± 5% RH|
|IVb||ASEAN testing conditions hot / high humidity||30ºC ± 2ºC||75% RH ± 5% RH|
|Refrigerated||-||5ºC ± 3ºC||N/A|
|Frozen||-||-15ºC ± 5ºC||N/A|