Stability Testing

Stability and Storage Testing Services to Support the Diverse Needs of Our Clients

To support regulatory submissions (FDA PMTA and MRTP), product development and product stewardship, we offer our clients a wide array of options for storage and shelf-life stability testing.

Stability Studies and ICH Storage Infrastructure

Our stability program has been developed with regulatory submissions in mind. Our infrastructure contains multiple walk-in climate controlled units and a facility housing 700 liter stand-alone climatic chambers that can be set to varying humidity and temperature settings to meet customized or ICH storage requirements. All storage chambers are monitored 24 hours a day, 7 days a week, and are control charted to ensure traceability. In the event of an electrical power failure, all chambers and walk-in units are connected to natural gas generators to maintain prescribed conditions until electrical power is re-stored.