Peristaltic filling machine RVFM

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Since the beginning of the design phase, we have been considering the capability to integrate the vial filling machine in an isolator system. Range 2R-100H Minimum downtime Vial filling machine designed for campaign production with containment technology. Vial transport with anthropomorphic vaporized H2O2 compatible STAUBLI robot. Maximum of 12 open vials involved in filling and stop pering operations at the same time throughout the machine (1 vial (RVFM1), 4 vials (RVFM2), 12 vials (RVFM5). Minimum format parts and electronic adjustment of all parameters for different vial sizes. Suitable for peristaltic and/or volumetricpiston pump dosing systems. Handling of single-use disposable system option. 100% in-process control (= IPC) or statistical check weighing system directly under the filling nozzles with feedback to dosing pumps. Net weight filling: no product waste fill up to target value for underfilled vials. No product waste during the product path priming. Nitrogen flushing before and after filling. Capping unit integrationon the same monoblock. Zero reject philosophy. Repeated operations for missing stopper detection. Continuous monitoring of the viable and non-viable particles. Compliance with cGMP, GAMP and 21CFR Part11 requirements.