cGMP Stability Testing

Moravek offers secure API storage and analysis in a dedicated cGMP Quality Control laboratory. Storage temperature options include +25 °C/60% RH, +4 °C, -20 °C, and -80 °C 

All cGMP APIs are stored in 21 CFR Part 11 compliant Rees Scientific temperature mapped and continuously monitored stability chambers. Temperature and pressure are recorded for and humidity of the +25 °C/60% RH is also recorded utilizing a Rees Scientific Environmental Monitoring System (EMS).  

The entire facility, including all stability chambers, operates with automatic backup power from a 500kW generator. This cloud-enabled, facility-wide backup power system from Cummins eliminates the effect of power outage the most likely cause of temperature excursions.  

An experienced Proposal Development Coordinator can work with our Quality Control and Quality Assurance staff to assist you with designing a stability study that will achieve your objectives.  

Results of stability testing are provided at each time point, and a final stability report is provided at the end of the stability study to summarize observations about the stability of the studied material.  

GMP Stability Testing

+4 °C, -20 °C, and -80 °C stability chambers

 500 kW Cummins generator