用于注射剂瓶、预灌封注射器和卡式瓶的灵活灌装并降低风险的无手套隔离器系统。
The SA25 aseptic filling workcell―a gloveless isolator―integrates proven technologies including robotics, nested containers and closures, and automated environmental monitoring. Our filling machine allows greater agility when compared to conventional isolator or restricted access barrier system (RABS) production lines by enable liquid filling of many products in different container formats. The companion Microcell™ vial filler is well-suited for small-batch vial filling in the fill finish step of aseptic processing.
The SA25 filling equipment can fill any nested vial, syringe, or cartridge format from 0.2 to 50 mL, with the ability to change between formats in just 45 min. So, when your forecast or pipeline changes, you can be ready for it.
Discover how our innovative first-to-market gloveless, robotic approach supports EU-ANNEX-1 and other regulatory requirements – and how we’ve created a standard solution for aseptic filling to enable control, risk reduction, and speed. Not only do our customers leverage the workcells for preclinical and clinical production, but they scale up on the same line for commercial production. Four agencies have approved commercial drug products filled on Cytiva workcells: Health Canada, FDA, China NMPA, and Singapore HSA.
Manufacturing and filling sterile drug products are complicated and challenging endeavors. That’s why we created the Cytiva aseptic filling user group, so you don’t have to reinvent the wheel. What better way to learn than alongside people who’ve already found solutions to your challenges? Hear from members of the user group as they discuss the peer-reviewed article published in AAPS PharmSciTech using data gathered from SA25 aseptic filling workcells to support advanced environmental monitoring strategies.
Our aseptic filling qualification solutions are specifically designed to reduce the complexity associated with qualifying your workcell. By engaging with our experienced team, you will be fully supported by their expertise to smooth your journey to qualification success. Download the aseptic filling qualification services data file.
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