Full Description
This will be a substantial revision of a well-regarded work in the biopharmaceutical area, that supplies a basic education of cleaning validation. Each chapter will be updated with major emphasis put on microbiological cleaning of equipment surfaces, protocols for encapsulation machines and manufacturing vessels. There will also be extensive coverage on WHO (World Health Organization) good manufacturing guidelines for clean validation standards. The author is also proposing the inclusion of specific case studies related to appropriate chapters, where the author's own technical experience in these matters will be illustrated.
Contents
How to Establish a Cleaning Validation Program. Introduction. Scope and Approach. Cleaning Validation Team Members and Responsibilities. Cleaning Validation Philosophy. Planning Phase; Analytical Testing and Reporting Phase. Equipment Description. Facility Description. Utilies Description. Utilities Monitoring and Microbiological Controls. Microbiological Cleaning of Equipment Surfaces. Solubility of Active Materials in Water. Toxicity of Active Materials. Cleaning Validation Products Grouping Matrix. Product Equipment Training Matrix. Cleaning Validation Protocols for Fluid Bed Dryer. for Mixer. for Granulation Machines. for Powder Bins. for Sieve. for Encapsulation Machines. for Protocol Pans. Cleaning Validation Protocol for Freeze Dryer. for Glass- Lined Mobile Tank. WHO Good Manufacturing Guidelines for Cleaning Validation.Health Products and Food Branch Inspectorate Guidance Document Cleaning Validation Guidelines. Qualification and Validation. Sampling Tools. Recommended Readings.
