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Stability studies

Testing & storage services

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.

Estudios_de_estabilidad

ALS: Your partner & collaborator

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.

lab scientists

ALS: Storage stability & testing 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.

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Stability Security

  • All chambers are kept locked with restricted access
  • Audible and visual alarms for temperature and humidity (above and below set conditions)
  • Data loggers have email and auto dial alert functionality
  • UPS on data logger ensuring continuous monitoring and alarm call outs


Storage conditions & climatic zones

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


Non-standard conditions

We realize that from time to time, the standard ICH conditions may not be appropriate for a specific stability need. ALS can support range of non-standard temperatures and humidities with physical capacities from small single cabinets up to dedicated large walk-in stability rooms. Alternative conditions can be made available upon request.

Photostability

Whether performing forced degradation or confirmatory studies, ICH Q1B guideline standardises the approach to photostability testing on pharmaceutical drug substances and drug products. Samples should be exposed not less than 1.2 million lux hours with near ultraviolet energy of not less than 200 watt hours/square meter. Contact us to find out more about how we can help you with your photostability testing.

Business Continuity Planning

The disruption of in-progress stability trials can sometimes lead to delayed product launches, damage to product lifecycle, and critical losses for pharmaceutical manufacturing organizations. ALS works collaboratively with partners to help ensure continuity in those rare but critical times of need. Our offering includes:

  • Storage during downtime and in support of disaster recovery
  • Storage of retention and spare samples for critical projects/studies
  • Dedicated Space: pre-agreed space reservation for critical conditions
  • Temperature controlled transport to aid logistics
  • Stability storage facilities across Europe, USA, and Asia to support cost effective and seamless outsourcing wherever manufacturing organizations are based
 
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