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Process Analytical Technology (PAT) & Data Analytics (162)
BioPAT ® MFCS enables a new standard in bioprocess data management and automation. Its capabilities for data acquisition, process trend monitoring, and recipe management and control make it an ideal tool for all up and down stream processes, no matter if you prefer single-use or reusable systems. Whether you want a non-qualified system for your PD facility or a qualified system that can meet your 21 CFR part 11 or Annex 11 needs we have deployment option sized for you.
Creating recipes can be a time-consuming and tedious task, especially when complex automation strategies must be implemented. Leverage the experience of the Sartorius MFCS engineers, which can create a ready-to-use BioPAT® MFCS recipe template for perfusion and concentrated fed-batch cell cultivation guided by on-screen instructions for Biostat STR® 50L, and Biostat® B-DCU 2L, 5L or 10L including:
S88 phases for bioreactor preparation, cell growth, production and product harvesting.
Automated algorithms for cell-density-based control of media and feed flow rates, cell bleed flow rates mixing, oxygen transfer and CO2 stripping and antifoam dosing (if applicable).
Optimized, scale-dependent control parameters.
Predefined alarm settings for early warning and timely mitigation of failure modes.
Comprehensive documentation.
Optional available qualification services.