NIPTE-FDA Collaborative Case Study On Model-based Design Space Development Across Scales & with Stability Considerations. Preliminary Design Space. Define Target Product Profile (TPP). Derive Quality Attributes from TPP. Propose Manufacturing Process. Risk Analysis ( FMEA ).
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On Model-based Design Space Development Across Scales & with Stability Considerations
Preliminary Design Space
courtesy: Dr. Steef. Boerrighter, Purdue University
Bulk density 0.46 kg/m3
Min Punch Gap
Press speed 21120 tab/hr
Significant increase in STS at extreme conditions
End Moisture Target = 0.5%
End Moisture Target = 1%
L0, in-process lactam
D0, crystal damage
X – Wet Massing Time
Y – Water Content