Stability Storage and Testing
We offer comprehensive and cost-effective stability management, in accordance with cGMP and ICH guidelines. We work with you to provide a quality service meeting your specific storage and testing needs.
Our stability storage and testing services include a range of monitored temperature, humidity, and light stability storage conditions meeting ICH Guidelines, covering requirements for climatic zones I to IV. We are 21CFR-compliant, and can store Schedule I to V controlled drugs. Low temperature storage is available and we are able to set up additional non-standard temperature/humidity conditions upon request. Whether you require storage only, or in combination with in-house analytical testing, we tailor our service to meet your needs.
Be assured that you can rely on our storage facilities. Our stability units are secure, fully validated and maintained, and we have a backup cabinet and procedures in place in case of breakdown. Temperature and humidity are monitored 24 hours a day, and we have a dedicated out of hours response team in case of emergency.
We have experience in the development of stability indicating methods, including photostability and other stress condition studies. From protocol preparation to the issue of final reports, we offer comprehensive project management, plus advice and support.
Our stability storage conditions:-
- -80°C and -20°C freezers
- 5°C refrigerated storage
- 25°C/60%RH long term stability storage
- 30°C/65%RH intermediate stability storage
- 30°C/75%RH and 40°C/75%RH accelerated stability storage
We can help with:-
- Temperature cycling studies
- Stability trending
- Development and validation of stability-indicating methods
- Dispatch to testing sites under controlled conditions