Cleaning, Cleaning Validation
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Introduction
Product Sources
Intended Use of Product
Position in Processing Train
Phase of Product Development
Multiproduct versus Dedicated Equipment and Facilities
Unit Operations
General Considerations
Chemical Methods
Physical Methods
Combining Methods
Methods for Evaluating Cleanliness
Setting Limits
Cleaning Validation
Case Studies
Validation of CIP of a Bioreactor
Changeover of Equipment from Development to a Dedicated Unit
CIP Validation in a Multiproduct Facility
Summary
Bibliography
Keywords:
assays;
cleaning;
cleaning methods;
equipment;
multiproduct;
nucleic acids;
proteins;
unit operations;
validation;
viruses