From study design, storage and shelf-life stability to monitoring, analytical testing and documentation, SGS offers comprehensive stability testing services.
When it comes to testing the stability of your pharmaceutical and biologic projects, you need world-class expertise and resources. With over 25 years of experience and currently more than 100,000 samples on storage, our life science laboratories have the skills and capacity to handle your pharmaceutical and biologic stability projects.
We provide a complete range of storage conditions in numerous climatic walk-in chambers and climatic cabinets with a total storage capacity of more than 2,400 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
We provide you with:
- 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 stability samples
- Interim reports for every testing period
- Comprehensive final report
We offer the following 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
Long-term, intermediate and accelerated storage includes:
- 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
To find out more about our stability testing services, contact us today.