Lyophilization, or freeze-drying, is a process used to prepare material for transport or to extend the shelf life of perishables; it is also used in the production of biotechnology products. The process requires freezing the material, then reducing the chamber pressure to remove water from the material through sublimation. As such, both temperature and pressure parameters must be measured during qualification. Additionally, the unit’s sterilization cycle must be maintained in a qualified state.
Masy BioServices offers all required validation equipment, including premium-grade thermocouples and vacuum standards, to complete your lyophilizer qualification, for both the freeze-dry and sterilization cycles. Our trained validation engineers can work with you on developing a validation protocol, or suggest the use of an existing document. We can perform all aspects of the qualification, from protocol development through execution, and present a quality-reviewed documentation package which includes the executed protocol, data and analysis, and NIST-traceable calibration certificates for all equipment used.
Contact Masy BioServices today for your lyophilzer qualification needs.