Stability Studies

From study design to storage, monitoring, analytical testing and documentation, SGS offers services to your complete satisfaction. With more than 25 years of experience and currently more than 100,000 samples in storage, SGS has the skills and the capacity to handle your stability projects. SGS can provide its customers with the complete bandwidth of storage conditions in numerous climatic walk-in chambers and climatic cabinets with a total storage capacity of over 2,400 m3. Various refrigerators and freezers are available for storage at lower temperatures. All storage chambers are fully controlled with 24h/7d monitoring and alert systems (21 CFR part 11 compliant). For your safety, SGS operates back up chambers for complete sample retrieval.

Services

- Support in designing studies for real time, stress tests and photo stability 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

Climatic Zones (ACCORDING TO ICH & WHO)

I. 21°C / 45% r.h.
II. 25°C / 60% r.h.
III. 30°C / 35% r.h.
IVa. 30°C / 65% r.h.
IVb. 30°C / 75% r.h.

Long-Term, Intermediate & Accelerated Storage

- 25°C / 40% r.h. (semi-permeable container study)
- 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.
- +5°C
- –20°C
- –80°C
- Photostability
- Transport stability (freeze and thaw, cycle test)
- In-use stability
- Customer-specific conditions