Ramping Chamber Qualification
Ramping chambers approach a set temperature at a specified rate and maintain that temperature for a specified length of time. Profiles can be set up within the controller of the unit to define cycling programs that can ramp through an array of different temperatures at predetermined periods of time. These chambers are typically used for the stability testing of drug product, as specified in 21 CFR Part 211, to determine appropriate product storage conditions, simulate logistical studies, etc.
Masy BioServices can perform installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) services to validate your ramping chamber performance, and employ trained validation engineers to provide a program setup and a full scale validation service, from protocol generation to final report review.
Contact Masy BioServices today for your ramping chamber qualification needs.