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Improved Pharmaceutical Process Optimization, Managed by Tracking Capability Indices for Bulk Drug Solid Surface Properties
by Ben Yellin, PhD and Arthur Mlodozeniec, PhD; Conformia Inc., Redwood City, CA

Abstract
Both short term (Cp) and long term (Cpk) performance for pharmaceutical processes such as particle size reduction and mixing can be determined for pharmaceutical powders. The process chemist often possesses more than enough data and information about the key process parameters which define the quality or capability of the unit operation. The output is measured using variable data at a specific opportunity for a defect. The collection of Cp and Cpk measurements can close the specification limits to those most desired by the customer. Often for the process chemist, this is the host pharmaceutical manufacturing center. The two case studies illustrate the improvement in technology transfer achieved by sharing information for process optimization during scale-up operations. Examples of particle size/surface area and other variables (solubility, suspension dispersion, and mixing efficiencies) illustrate the quantitative measure of process capability,... desirable for pharmaceutical dosage forms designed for manufacturability.