Product temperature is the most critical parameter during lyophilization; however it is rarely measured during commercial GMP production of sterile injectable pharmaceuticals. With Tempris® wireless, battery-free product temperature sensors this is now possible. We will present examples with data highlighting the differences between laboratory and production thermal environments within lyophilizers. A case study of a customer using Tempris® probes for every batch (over 150 now) without a single lot rejected due to issues with the lyophilization cycle. The customer has filed the use of Tempris® with regulatory authorities and as a result, they have greater regulatory flexibility for cycle conditions and future changes in vial and lyophilizer. Jim Searles is currently an independent consultant in the areas of lyophilization and sterile injectable product development and manufacturing. He has held managerial and technical positions in manufacturing science and technology and product development at large companies such as Pfizer, Merck and Eli Lilly as well as start-up companies Aktiv Pharma Group and Aktiv-Dry. Jim has M.S. and Ph.D. degrees in Chemical Engineering from the University of Colorado. His Ph.D. dissertation was on heterogeneity phenomena during lyophilization. Jim has experience with virtually every type of sterile injectable product including vaccines, proteins, antibodies, small molecules and antibiotics. He also has significant experience developing alternatives to lyophilization such as spray freeze-drying, spray drying, spin lyophilization, and cryogenic nozzle spray drying. He has provided advanced technical support to company internal and external contract manufacturing sites around the world and has also interfaced with client companies as a technical SME and area lead within a CMO (Pfizer CentreOne and Hospira One2One).
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