Failure of Glass Tubing Vials during Lyophilization

Machak, David R.; Smay, Gary L.

doi:10.5731/pdajpst.2017.008276

Cited by 7 publications

(1 citation statement)

References 5 publications

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“…Glass vials with lower numbers of thermal expansion coefficient are more dimensionally stable against thermal expansion stress that can result in cracking. Therefore, 33 expansion glass is a preferable vial material for lyophilized products [31,32].…”

Section: Vial Breakagementioning

confidence: 99%

Best Practices and Guidelines (2022) for Scale-up and Technology Transfer in Freeze Drying Based on Case Studies. Part 2: Past Practices, Current Best Practices, and Recommendations

et al. 2023

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Scale-up and transfer of lyophilization processes remain very challenging tasks considering the technical challenges and the high cost of the process itself. The challenges in scale-up and transfer were discussed in the first part of this paper and include vial breakage during freezing at commercial scale, cake resistance differences between scales, impact of differences in refrigeration capacities, and geometry on the performance of dryers. The second part of this work discusses successful and unsuccessful practices in scale-up and transfer based on the experience of the authors. Regulatory aspects of scale-up and transfer of lyophilization processes were also outlined including a topic on the equivalency of dryers. Based on an analysis of challenges and a summary of best practices, recommendations on scale-up and transfer of lyophilization processes are given including projections on future directions in this area of the freeze drying field. Recommendations on the choice of residual vacuum in the vials were also provided for a wide range of vial capacities. Graphical Abstract

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Section: Vial Breakagementioning

confidence: 99%