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Criticality Assessment- Identification of Critical Quality Attributes ...

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B mm<br />

A mm<br />

Roll gap<br />

Case Study-Dry Granulation Design Space:<br />

<strong>Critical</strong> Process Parameters<br />

Roll<br />

force<br />

x bar y bar<br />

low<br />

<strong>Critical</strong> Process Parameter<br />

Polymer<br />

Roll Gap<br />

Roll Force<br />

high<br />

<strong>Critical</strong> <strong>Quality</strong> <strong>Attributes</strong><br />

Hardness<br />

Dissolution<br />

Pfizer • 34

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