Transcription of Systems-Based Inspections Describe cleaning …
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Systems-Based Inspections Describe cleaning …
cleaning Validation/LeBlanc/FDA DG 230 July 20, 201711 Systems-Based Inspectionsfor cleaning ValidationFDA DG 230 July 20, 2017 New Orleans, LADestin A. LeBlancCleaning Validation Describe cleaning processes andapproaches Identify various techniques utilizedto measure the effectiveness ofcleaning processes Identify documents associated withcleaning validation processes Identify significant issues and typicalproblems with cleaning validation3 cleaning Definition: The process ofremoving potential contaminantsfrom process equipment such thatthe equipment can be safely usedfor subsequent productmanufacture Focus for this presentation isprocess equipment, not cleanroomcleaning4 Critical cleaning ?
Cleaning Validation/LeBlanc/FDADG 230 July 20, 2017 5 25 Residues measured How selected? Should be based on what cleaned, how cleaned, and effects on next product Minimum is usually active, cleaning agent, and bioburden Others that may be important Endotoxin Degradants or byproducts 26
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