The modern design of STERILINE filling machines takes into consideration the newest requirements of the filling process:
- In line transport and small width, suitable for the application of RABS and isolators, reduce the volume to be monitored and sterilized;
- Continuous monitoring of the viable and non viable particles;
- Filling by volumetric pumps and/or peristaltic pumps actuated by servomotors, that allow precise filling and easy adjustment of the pumps by means of the HMI;
- Nitrogen purging inside the containers before, during and after the filling;
- 100% IPC (In Process Control) of the weight and statistical Check Weighing system with feedback to the dosing pumps;
- Possibility of performing prefilled syringes, loaded from the nests;
- Vibration generator for the bowl of stoppers inside the mechanical volume, below the process area;
- Capping station designed to reduce particle generation, by rotating the vials under the blades.
All Steriline filling machines are in compliance with cGMP, GAMP and 21CFR Part11 requirements.