%0 Journal Article %A Tim Dreckmann %A Imke Sonja Ludwig %A Joerg Luemkemann %A Joerg Huwyler %T Low-Volume Aseptic Filling Using a Linear Peristaltic Pump %D 2020 %R 10.5731/pdajpst.2020.011858 %J PDA Journal of Pharmaceutical Science and Technology %P pdajpst.2020.011858 %X Abstract The pharmaceutical industry has been confronted with new and complex challenges, particularly with regard to the aseptic filling of parenterals, including monoclonal antibodies and ophthalmologic drugs designed for intravitreal injections, which often require fill volumes less than 200 μL. In addition to intravitreal administration, microliter doses may be required for applications using highly concentrated formulations and cell and gene therapies. Many of these therapies have either a narrow or unknown therapeutic window, requiring a high degree of accuracy and precision for the filling system. This study aimed to investigate the applicability of a linear peristaltic pump, as a novel and innovative filling system for the low-volume filling of parenterals, compared with the state-of-the-art filling systems that are currently used during pharmaceutical production. We characterized the working principle of the pump and evaluated its accuracy for a target fill volume of 50 μL. Our results demonstrated that the linear peristaltic pump can be used for fill volumes ranging from 12−420 μL. A deeper investigation was performed with the fill volume of 50 μL, because it represents a typical clinical dose of an intravitreal application. The filling accuracy was stable over an 8-hour operation time, with a standard deviation of +/- 4.4%. We conclude that this technology may allow the pharmaceutical industry to overcome challenges associated with the reliable filling of volumes less than 1 mL during aseptic filling. This technology has the potential to change aseptic filling methods by broadening the range of potential fill volumes while maintaining accuracy and precision, even when performing microliter fills. %U https://journal.pda.org/content/pdajpst/early/2020/10/16/pdajpst.2020.011858.full.pdf