PFS Semi-Automatic Filling And Closing Machine
PFS Semi-Automatic Filling And Closing Machine
Manual opening of the bag. Manually Tyvek lid removal and inner liner removal. Liquid Filling by a piston pump. High filling accuracy. Rubber stoppering is done by stopping the vacuum chamber. High rubber stoppering accuracy. Easy access to the individual station because of the Narrow machine’s compact design.
Technical Specification :
| System | TYVEK REMOVER | Filling | Closing | Heads | speed |
|
| RI/PFS/SEMI/G1 | Mechanical | Manual | Rotary Piston Pump/Peristaltic Pump | Vacuum | 10/5 | 5000-6000 |
| RI/PFS/SEMI/G1 | Mechanical | Manual | Rotary Piston Pump/Peristaltic Pump | Vacuum | 10/5 | 5000-6000 |
Optional Accessories :
- Auto Chamber Door
- Nested syringe loading/Unloading
- IPC With 21 CFR part 11 compliance (scada system)
- Monitoring and particle counting
Documentation & Qualification
- In pharmaceutical production, Good Manufacturing Practices (GMP) are essential to guarantee that the manufacturing process is constantly controlled according to quality standards, and the drugs can be used safely.
- Therefore, there must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process, ensuring clarity and traceability of the product quality data acquisition.
- At RADIANT INDUSTRIES, we defined specific actions to ensure that our document management, which we call GDP (Good Documentation Practices), fulfills this objective.
- Document management starts with the client’s specifications (URS) which help us understand the customer’s needs and define the machine’s configuration accordingly. The required machines’ functionality will be tested later during the qualification tests.
- The whole process is described in the picture below, showing the comprehensive Qualification Project Plan (QPP) that covers from mechanical assembly to software and control configuration:
