Control of process parameters (such as temperature, vacuum and time), and equipment operating performance must be challenged carefully. It is also important to understand factors unique to each Freeze dryer; e.g. the vial’s position on the Freeze dryer shelf may have an impact on product quality and batch uniformity.
Following Installation Qualification (IQ) and Operational Qualification (OQ), a complete Performance Qualification (PQ) must be done by thermal mapping. Comprehensive PQ guarantees a production and a process fully reliable, and gives the assurance of the highest product quality and batch uniformity.
Product mapping represents valuable data for process understanding. Temperature recorded via thermocouples placed inside vials filled with product, positioned at specific (worst case) location on shelves. A 24 to 72 hour loaded study with vials must be performed.