Background
The filling process is important as it can impact product quality such as filling accuracy, aggregation and sub-visible particles. The critical process parameters of peristaltic filling pump were evaluated using OFAT and DOE methods.
Result
No liquid spatter or droplets were observed across all parameter variances within defined operation ranges. All quality attributes, including visible particles, sub-visible particles, extractable volume, and SEC, met the required standards.
Table 1. 4 Process Parameters at 3 Levels Evaluated in a Customer Design of Experiments
Figure 1. Control Space of Filling Process Critical Parameter