Process Equipment Related Leachable Compounds – 3 case studies Case 1: Over sterilized filter, 3 days instead of 3 hours – process leachable compounds in the parenteral drug product Case 2: Solid, white, 5 mm flakes in process equipment – effects on the parenteral drug products Case 3: What is wrong with the process equipment? – PERL investigation continued as a rubber stopper related leachable analyses.
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