ABSTRACT
Overview .......................................................................................................255 Regulations ....................................................................................................256 Selecting Cleaning Agents ...........................................................................256 Selecting Cleaning Agent Suppliers ...........................................................258 Cleaning Methods ........................................................................................259 Critical Parameters .......................................................................................259 Equipment Design Considerations ............................................................260 Cleaning Method Design ............................................................................261 Product and Equipment Grouping ............................................................262 Sampling Methods (Direct and Indirect) ..................................................263 Sample Site Selection....................................................................................263 Recovery Studies ...........................................................................................263 Analytical Detection Methods ................................................................... 264 Residue Limits and Acceptance Criteria ...................................................265 Cleaning Validation Master Plan and Validation Protocol Design........266 Cleaning Standard Operating Procedures ................................................267 Change Control ............................................................................................267 Biological Contamination ...........................................................................268 QbD and PAT Considerations ....................................................................269 Conclusion ....................................................................................................269 References ......................................................................................................269
