Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Cavitation in Pharmaceutical Manufacturing

Version 1 : Received: 6 July 2020 / Approved: 7 July 2020 / Online: 7 July 2020 (17:37:58 CEST)

How to cite: Sederstrom, D.; Rodrigues, R.V.; Lengsfeld, C. Cavitation in Pharmaceutical Manufacturing. Preprints 2020, 2020070138 (doi: 10.20944/preprints202007.0138.v1). Sederstrom, D.; Rodrigues, R.V.; Lengsfeld, C. Cavitation in Pharmaceutical Manufacturing. Preprints 2020, 2020070138 (doi: 10.20944/preprints202007.0138.v1).

Abstract

Therapeutic proteins are used to successfully treat hemophilia, Crohn’s Disease, diabetes, and cancer. Recent product recalls have occurred because of sub-visible particle formation resulting from the inherent instability of proteins. It has been suggested that particle formation is associated with late stage processing steps of filling, shipping, and delivery. Previous works demonstrated that cavitation might occur in therapeutic vials subjected to agitation or accidentally dropped, but that mitigation can be achieved with fluid property manipulation. The goal of this research was to (1) assess the risk of cavitation under common pharmaceutical manufacturing conditions (i.e., pipe contraction and pumps), (2) establish a simple threshold criterion for when particulate will form, and (3) suggest a series of mitigation techniques based on these thresholds. To accomplish these tasks, computational fluid dynamic simulations for a variety of pipe contraction and fluid properties were performed. The results of this research show that reducing the turbulence in a fluid system will reduce the likelihood of cavitation. Additionally, threshold bounds were created that establish a definitive transition at which cavitation will occur.

Subject Areas

hydrodynamic cavitation; cavitation number; turbulence; critical pressure; Kolmogorov length scale

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