Life Sciences Stability Studies
From study design to storage and shelf life stability, to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.
With more than 20 years’ experience and currently more than 100,000 samples on storage, SGS’s Life Science Services has the skills and the capacity to handle your stability projects.
We provide our customers with a complete range of storage conditions in numerous climatic walk-in chambers and climatic cabinets with a total storage capacity of more than 1,200 m3. Various refrigerators and freezers are available for storage at lower temperatures.
All storage chambers are fully controlled with 24/7 monitoring and alert systems (21 CFR part 11 compliant). For your reassurance, we operate back up chambers for complete sample retrieval.
Stability Study Testing Services
- Support in designing studies for real time, stress tests and photostability studies
- Development and validation of “stability indicating methods“
- Examination of stability-relevant parameters
- Storage and management of the stability samples
- Interim reports for every testing period
- Comprehensive final report
Climatic Zones (According to ICH)
|I.||21°C / 45% r.h.|
|II.||25°C / 60% r.h.|
|III.||30°C / 35% r.h.|
|IV.||30°C / 70% r.h.|
Long-term, Intermediate and Accelerated Storage
- 25°C / 40% r.h.
- 25°C / 60% r.h.
- 30°C / 65% r.h.
- 30°C / 70% r.h.
- 30°C / 75% r.h.
- 40°C / 75% r.h.
- 40°C / not more than (NMT) 25% r.h.
- Customer specific conditions
- Transport Stability (freeze and thaw, cycle test)
- In-Use Stability