Stability
With many years of experience and thousands of samples on current storage in custom built, walk-in storage rooms, Eurofins BPT-Melbourne has the skills and capacity to support your Stability Programmes.
Features of our Stability Storage Chambers
- Fully validated to ICH Q1A (R2) requirements and meeting strict temperature,
relative humidity and uniformity requirements. - Fully controlled with round the clock 24/7 monitoring and electronic alert system.
- UPS back-up with on-site power generator in the event of a power outage.
Stability Services
- Complete Stability Storage and Testing services
- Storage Only service with temperature loggers during transportation if required
- Support in designing studies for real time, stress tests and photostability studies
- Development and validation of Stability Indicating Methods
- Storage, coordination and management of stability samples
- Backup storage facility for customer’s in-house stability samples due to emergencies
- Stability Protocol Writing as required or incorporating Client-written Protocols
Long term, Intermediate and Accelerated Condition (ICH Q1A (R2))
- 2-8°C
- 25°C / 60% RH
- 30°C / 65% RH
- 30°C / 75% RH
- 40°C / 75% RH
- Photostability chambers
- Customised storage conditions
- −20°C
- Cold chain transportation study (freeze-thaw cycles)
Contact us for a Quote on: Info-BPT-MEL@eurofins.com