Moravek offers secure API storage in a dedicated Quality Control laboratory that complies with FDA guidance ICH Q7 for release and stability study of APIs. Storage temperature options include +25 °C/60% RH, +4 °C, -20 °C, and -80 °C.
Storage of all GMP APIs is compliant with 21 CFR Part 11 and all stability chambers are temperature mapped and continuously monitored with a Rees Scientific Environmental Monitoring System (EMS).
The temperature and pressure of our Quality Control laboratory are recorded. The temperature of each storage chamber and the humidity of the +25 °C/60% RH chamber are also recorded.
The entire facility, including all stability chambers, operates with backup power utilizing a 500kW generator and automatic transfer switches. This Cummins, cloud–enabled, facility-wide backup power system eliminates the most likely cause of temperature excursions that would result from interruption of power from the electric company.
An experienced Proposal Development Coordinator can work with our Quality Control and Quality Assurance staff to assist you with selecting a storage option that will achieve your objectives.