Presented ByJ. Richard Creekmore

US Technology ManagerAstraZeneca Pharmaceuticals

Process Robustness: Development to Life Cycle

Management

Tolerance Limits

• Understanding of tolerances comes from experimentation (DOE) and experience.

• Best to have ranges for as many variables as possible, but not practical.

• Decide which ones are more important (QRA)• Some cannot be determined because no method

can determine the difference. Only downstream processing and testing might work, e.g. blend uniformity of a non-flowing mixture.

Operating Ranges

Δ Zone

Proven acceptable range or design space may not fill the operating range completely

Process Robustness: From Development to Life Cycle ManagementOctober 10, 2013 11:15am - 12:15pmRichard Creekmore, US Technology Manager, AstraZeneca PharmaceuticalsTrack: Manufacturing & OperationsLevel: Beginner

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