Written by an expert especially for those who must design validatable cleaning processes and then must validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program
Written by an expert especially for those who must design validatable cleaning processes and then must validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program
o Cleaning Objectives. Cleaning and Cleaning Agents. Cleaning Methods. Process Parameters in Cleaning-Part I. Process Parameters in Cleaning-Part II. Cleaning Cycle Development. Grouping Strategies. Setting Acceptance Criteria. Analytical Methods for Cleaning Validation. Sampling Methods for Cleaning Validation. Microbial Issues in Cleaning Validation. Change Control and Revalidation. Special Topics in Cleaning Validation. FDA Expectations. Appendices.
o Cleaning Objectives. Cleaning and Cleaning Agents. Cleaning Methods. Process Parameters in Cleaning-Part I. Process Parameters in Cleaning-Part II. Cleaning Cycle Development. Grouping Strategies. Setting Acceptance Criteria. Analytical Methods for Cleaning Validation. Sampling Methods for Cleaning Validation. Microbial Issues in Cleaning Validation. Change Control and Revalidation. Special Topics in Cleaning Validation. FDA Expectations. Appendices.
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