| FILLING
LINE SYSTEM ANALYSIS |
|
| Objective |
- Gain better understanding of the filling system
dynamics
- Predict possible causes of low dose in system
- Understand effect of equipment changes and process
modifications on low dose
|
| Results |
- Effect of tank level on:
- Manifold pressure
- Pump pressure
- Mass delivered per needle
- Effect of manifold size on system performance
- Effect of line speed on system performance
- Effect of recirculation pump dynamics on system
performance
|
| Benefits |
- Provide understanding of design and process
parameters on low dose problem
- Provide final component and process
design
- Cost effective method to study design and process changes
|
- Removal of intermediate filling tank
- Removal of recirculation pump
- Analysis results can be used for FDA validation
- Minimize costly downtime
|
