presented by j. richard creekmore us technology manager astrazeneca pharmaceuticals process...
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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
To register for the INTERPHEX Puerto Rico Educational Program, please visit:
www.interphexpuertorico.com/en/Register-Now/
October 10-11, 2013 | Puerto Rico Convention Center | San Juan, Puerto Rico
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