Pharmaceutical Perspectives on Detergents and Cleaning Validation: Regulation and Current Practices

Venue: Indian Lakes Resort

Location: Bloomingdale, Illinois, United States

Event Date/Time: May 06, 2008 End Date/Time: May 06, 2008
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Pharmaceutical cleaning is changing, as the soils personnel leave behind are increasingly complex. A focus on novel dosage forms and delivery systems has resulted in the use of release modifiers and polymeric content. The Active Pharmaceutical Ingredients (APIs) are more targeted and more potent. These unique factors have resulted in the need for innovation in the field of cleaning. Comprehensive, compliant cleaning validation programs address both the needs of the regulators and the challenges of the soils. In this session, participants will address surfaces, methods of cleaning, and common cleaning agent types and their uses, as well as methods to verify the effectiveness of cleaning and removal of the detergent at the conclusion of cleaning. Key among the topics will be the generation of scientific rationales to defend an approach to cleaning and cleaning validation.