A particulate reduction program that comprehensively addresses particulate matter risks with the aim of advancing discussions based on objective data rather than subjective risks.
Single-use systems (SUS) are increasingly being used in final filling, vaccine manufacturing, cell therapy, and gene therapy. Regulatory requirements regarding particulate matter are clear for final pharmaceuticals, but they are not clear for SUS used in the upstream processes of final pharmaceuticals. In 2016, Sartorius launched a particle reduction program to reduce uncertainty and minimize the risk of particulate matter contained in SUS being introduced into final pharmaceuticals. As a result of this initiative, the levels of particulate matter in SUS have visibly decreased.
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▪ VDI (Visual Inspection) Inspection of visible defects, including visible particles, in all bag chambers. ▪ VPT (Particle Extraction and Measurement) Monitoring of visible particles on representative products using liquid extraction and microscopic counting. ▪ Lot-based VPT (Optional Service) Monitoring of visible particles extracted from actual manufacturing lots using liquid extraction and microscopic counting. VPT is just one step in Sartorius' particle reduction program. By monitoring events and trends over time, we can deepen our understanding of the sources and nature of particulate matter. Sartorius can embark on continuous improvement to reduce visible particle levels over time by combining other steps of the particle reduction program. VPT is one of the pillars to ensure consistency in quality between batches, leading to a reduction in risks related to patient safety. This new approach continues to support the use of SUS in critical applications.
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Sartorius Stedim, established in 2007 through the merger of the German company Sartorius, founded in 1870, and the French company Stedim, is a pioneer in "Single-Use Technology (SUT)." As a company capable of providing comprehensive technical support to the pharmaceutical and biotechnology industries, its cutting-edge technology is highly regarded worldwide in the fields of scientific instruments and biotechnology.