The Crystal® PX family is designed to meet large scale pharmaceutical filling with capacities ranging from 100 vials/min (4 filling nozzles) up to 180 vials/min (8 filling nozzles). Typical batch size may reach 80,000 vials on a single shift basis. Process Filling ■ Ready-to-fill AT-Closed Vials® organized in trays are automatically loaded and transported to the conveyor. ■ Filling is performed by means of specially designed needles that pierce the stoppers and dispense the liquid inside the vials. Laser re-sealing ■ The filled vials are then automatically transported to the laser sealing zone, where laser heads re-seal the puncture trace on the stoppers surface with 1 second shot. ■ The capping is performed inside the barrier, by simple snap-fit of a plastic cap. Compliance Fully compliant with cGMP requirements and CFR 21 Part 11, the Crystal® PX filling lines are able to easily process all sizes of ready-to-fill AT-Closed Vials®, from 1 ml up to 50 ml, thanks to minimized quick and tool-less format change. Member of SKAN Group

Crystal® PX Filling Lines: Specification IPC (In Process Control) PAT (Process Analytical Technology) Typical footprint Utilities Product Path Materials Aseptic filling of liquid parenterals, including cell and gene therapy products Up to 180 vials/minute and 10.800 vials/hour. 0.1 ml to 50 ml. Typically, 1% (over 1 ml, for water-like viscosity product). 100% filling check by weighing (up to 150 vial/min). 100% capping check. 100% laser re-sealing effectiveness. m²: 12 - 16 ft²: 130 - 172 Electricity only. No water, no compressed air. All single-use. AISI 316L for product contact parts. Compatible...