Robotic Aseptic Filling Isolator technology is a perfect combination of Robotic technology and Isolator for advanced aseptic processing, which provides extensive flexibility to support the complex drug filling processes of biologic therapies. This revolutionary system can significantly reduce drug product fill risk and provides greater aseptic assurance with the gloveless isolator design. Sterile products processed using single use technology are in strict accordance with cGMP requirements. It processes all ready-to-use nested, vial, syringe and cartridge formats for clinical and small and medium-batch commercial applications with high flexibility.
WuXi Biologics’ Drug Product Facility #4 (DP4) multi-product fill & finish facility features the Vanrx SA25 robotic, gloveless, isolator-based filling system. The facility is the first in China to use this technology platform. This gloveless, isolator-based system performs fully programmable, robotic functions with precision for all aspects of the fill from the moment you put the container closure or CCS components into the unit until the final drug product is produced. These fully robotic functions include Isolator leakage test, VHP sterilization of the container closures, filling into the CCS of choice using a single-use flow path, capping and delivery of the batch. On top of that there is integrated programmable and robotic microbe sampling and particle monitoring system amongst other in-process checks and integrated Electronic batch record. All of this is done without human intervention thus removing one of the key areas where mistakes can be made during Drug Product manufacture.
The aim of advanced aseptic processing is the elimination and absolute control of all sources of contamination – most importantly, human-generated contamination. Robotics and isolator-barrier systems will be the core technologies to advance this initiative further.