Operation Qualification for Lyophilization

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Validation as a Lifestyle

Operational Qualification
GAMP Qualification Diagram Next Page ==>

Chamber Rates and Tempertures

Maximum Supportable Sublimation Rate
Maximum Cooling Rate for empty and loaded shelves
Maximum Heating rate for empty and loaded shelves(and linearity) from -40 to +40
Minimum and Maximum attainable shelf temperatures
Minimum condenser temperature and time to achieve
Shelf Temperature Uniformity Map - Empty and Loaded

Dimensional data

Physical measurement of shelf dimensions and heights
Shelf separation after shelf lock-together

Stoppering pressure - vial no-stopper and break pressure define range

Control system

Complete Alarm testing
PLC Loop Check
HMI/MMI validation - often treated as a separate validation

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© 2005 Narlin Bennet Beaty, Ph.D.