A Cost-effective and Reliable Method to Predict Mechanical Stress in Single-use and Standard Pumps

Abstract

Pumps are mainly used when transferring sterile culture broths in biopharmaceutical and biotechnological production processes. However, during the pumping process shear forces occur which can lead to qualitative and/or quantitative product loss. To calculate the mechanical stress with limited experimental expense, an oil-water emulsion system was used, whose suitability was demonstrated for drop size detections in bioreactors 1 . As drop breakup of the oil-water emulsion system is a function of mechanical stress, drop sizes need to be counted over the experimental time of shear stress investigations. In previous studies, the inline endoscopy has been shown to be an accurate and reliable measurement technique for drop size detections in liquid/liquid dispersions. The aim of this protocol is to show the suitability of the inline endoscopy technique for drop size measurements in pumping processes. In order to express the drop size, the Sauter mean diameter d 32 was used as the representative diameter of drops in the oil-water emulsion. The results showed low variation in the Sauter mean diameters, which were quantified by standard deviations of below 15%, indicating the reliability of the measurement technique.

A Cost-effective and Reliable Method to Predict Mechanical Stress in Single-use and Standard Pumps

“…During the pumping process, mechanical stress can result in irreversible cell damage, which might impair the quantity and quality of the product [1][2][3][4] . The level of mechanical stress depends on the pump type and pump settings, as demonstrated in previous studies [5][6] . Commonly, peristaltic, syringe and diaphragm pumps are used for single-use (SU) technology based applications.…”

An overview of drive systems and sealing types in stirred bioreactors used in biotechnological processes

“…A different approach is usually applied in bearingless pump systems, which are used in biotechnology (Schöb 2002 ) as well as in medicine as left ventricular assist devices for the treatment of heart disorders (Schöb and Loree 2008 ) or to maintain blood circulation during heart transplants (Sung et al 2015 ). Bearingless pump systems are characterized by low shear stresses (Blaschczok et al 2013 ; Dittler et al 2014 ; Schirmer and Eibl 2018 ), which has led to their use in the operation of bioreactors (Reichert et al 2009 ; Schirmer et al 2018 ) and mixing systems in the pharmaceutical industry (Sartorius Stedim Biotech GmbH 2019 ).…”

Editorial: Single‐use technology in biopharmaceutical manufacturing

“…Engineering data (power input per volume, mixing time, volumetric mass transfer coefficient, Newton number) of single‐use bioreactors are also presented in the technical report about the BIOSTAT CultiBag STR‐series (50–2000 L), provided by Dreher et al . The possibility of using the Sauter diameter in order to predict shear stress in single‐use pumps and a method for clarifying and concentrating a cytomegalovirus‐like particle with single‐use cross‐flow technology are discussed for the first time in further technical reports. Cross‐flow filtration is also applied by Blaschczok et al , who exchange the growth medium with the production medium and induce a model protein expression in a biphasic mammalian cell‐based production process performed in a single‐use stirred bioreactor at pilot scale.…”