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Parameters Influencing Cavitation Within Vials Subjected to Drop Shock.

ABSTRACT: The pharmaceutical industry has made improvements to mitigate protein degradation during the drug manufacturing process, storage, and transportation. However, there is less quality control after the manufacturer releases the drug. Previous research has shown that drop shock due to mishandling and accidental dropping of therapeutic vials may cause cavitation, aggregation, and particle formation. In this study, the cavitation behavior of Deionized (DI) water and 10mM L-Histidine buffer solution which were subjected to drop shock by hand dropping were investigated to study the effects of vial materials, solutions, fill volumes, drop heights, and internal vial geometries. A Phantom v7 high-speed camera was used to record images at a rate of 66,700 frames per second of the vials as they underwent drop shock. These videos were then reviewed to find the angle of impact, and to determine if there was cavitation. The results indicate that decreasing fill height by using a smaller fill volume or larger diameter vials were found to mitigate cavitation across drop heights. Secondly, results indicate there is a significant difference between the cavitation behavior of glass and plastic vials, and plastic had more cavitation cases. Lastly, there was not a significant difference in the occurrence of cavitation between DI water and L-Histidine buffer solution.

SUBMITTER: Valotta Rodrigues R

PROVIDER: S-EPMC6915723 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Parameters Influencing Cavitation Within Vials Subjected to Drop Shock.

Valotta Rodrigues Rafael R Puryear Meagen M Sederstrom Donn D Lengsfeld Corinne S CS

Scientific reports 20191216 1

The pharmaceutical industry has made improvements to mitigate protein degradation during the drug manufacturing process, storage, and transportation. However, there is less quality control after the manufacturer releases the drug. Previous research has shown that drop shock due to mishandling and accidental dropping of therapeutic vials may cause cavitation, aggregation, and particle formation. In this study, the cavitation behavior of Deionized (DI) water and 10mM L-Histidine buffer solution wh ...[more]

PMID: 31844126

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Project description:Conflicting reports in the literature have raised the question whether radial extracorporeal shock wave therapy (rESWT) devices and vibrating massage devices have similar energy signatures and, hence, cause similar bioeffects in treated tissues.We used laser fiber optic probe hydrophone (FOPH) measurements, high-speed imaging and x-ray film analysis to compare fundamental elements of the energy signatures of two rESWT devices (Swiss DolorClast; Electro Medical Systems, Nyon, Switzerland; D-Actor 200; Storz Medical, Tägerwillen, Switzerland) and a vibrating massage device (Vibracare; G5/General Physiotherapy, Inc., Earth City, MO, USA). To assert potential bioeffects of these treatment modalities we investigated the influence of rESWT and vibrating massage devices on locomotion ability of Caenorhabditis elegans (C. elegans) worms.FOPH measurements demonstrated that both rESWT devices generated acoustic waves with comparable pressure and energy flux density. Furthermore, both rESWT devices generated cavitation as evidenced by high-speed imaging and caused mechanical damage on the surface of x-ray film. The vibrating massage device did not show any of these characteristics. Moreover, locomotion ability of C. elegans was statistically significantly impaired after exposure to radial extracorporeal shock waves but was unaffected after exposure of worms to the vibrating massage device.The results of the present study indicate that both energy signature and bioeffects of rESWT devices are fundamentally different from those of vibrating massage devices.Prior ESWT studies have shown that tissues treated with sufficient quantities of acoustic sound waves undergo cavitation build-up, mechanotransduction, and ultimately, a biological alteration that "kick-starts" the healing response. Due to their different treatment indications and contra-indications rESWT devices cannot be equated to vibrating massage devices and should be used with due caution in clinical practice.

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Parameters Influencing Cavitation Within Vials Subjected to Drop Shock.

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Parameters Influencing Cavitation Within Vials Subjected to Drop Shock.

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