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Modeling of the lyophilization process, based on the steady-state heat and mass transfer, is a useful tool in understanding and optimizing of the process, developing an operating design space following the quality-by-design principle, and justifying occasional process deviations during routine manufacturing. The steady-state model relies on two critical parameters, namely, the vial heat transfer coefficient, K v , and the cake resistance, R p . The classical gravimetric method used to measure K v is tedious, time-and resourceconsuming, and can be challenging and costly for commercial scale dryers. This study proposes a new approach to extract both K v and R p directly from an experimental run (e.g., temperature and Pirani profiles). The new methodology is demonstrated using 5% w/v mannitol model system. The values of K v obtained using this method are comparable to those measured using the classic gravimetric method. Application of the proposed approach to process scale-up and technology transfer is illustrated using a case study. The new approach makes the steady-state model a simple and reliable tool for model parameterization, thus maximizes its capability and is particularly beneficial for transfer products from lab/pilot to commercial manufacturing.

We have examined gamma sterilization compatibility for many of medical packaging materials. Techniques used include thermal analysis, physical testing, optical property evaluations, and failure analysis. For a variety of PVC formulations, gamma radiation often leads to discoloration. This results from conjugated poly‐ene sequences formed through dehydrohalogenation degradation during ionizing radiation. In addition to unacceptable color formation, excessive pH shifts and high extractables are often observed. For most polylefins, radiations was found to deplete the antioxidant package and lead to discoloration and/or mechanical failures. For polypropylenes, the degradation can lead to the well‐publicized catastrophic failures during post radiation shelf life storage. These examples and methods to ensure radiation compatibility and shelf‐life stability are presented.

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