Standardization of visible particles measurement in single-use systems, an advantage for the emerging applications

Conference Dates

March 20 – 23, 2022


The use of single-use systems (SUS) in biopharmaceutical and biotechnological industries has recently become much more common. SUS assemblies include plastic bags, tube lines and components. As much as possible, SUS should be “essentially free” of visible particles (≥100µm). The presence of visible particles inside the SUS is a visual indicator regarding the quality of product. During the biopharmaceutical manufacturing process, interactions between the drug substance contained in the bag and visible particles might lead to product quality issues. However, SUS free of particles remains a challenge due to the SUS manufacturing process which requires several steps of assembly and the presence of different components. The adoption of SUS can be a solution for the emerging applications, like vaccines and cell and gene therapy, especially in the pandemic time with a need to have products quickly and with a particulates level very low. For this reason, it is important to be able to extract, measure, characterize, and reduce the particles. SUS manufacturers need to demonstrate continuous improvement of their manufacturing process in order to limit visible particulate matter. Due to the complexity of the SUS (bags, tube lines, components, transparency, size ...), it is difficult to do a visual inspection of the entire product. To overcome this issue, the development of a visible particle test method is necessary to assess the number of visible particles contained inside the SUS, which then allows assessment of any risks linked to particle matter. This method allows to extract, count and size the particles inside SUS, and to identify particles according to their shape, color and infrared and/or Raman spectrum. That is why Sartorius co-worked with ASTM to develop a standard practice [[i]] for the extraction of particulate matter from the surfaces of single-use components and assemblies designed for use in biopharmaceutical manufacturing.

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