Speaker: Roger CowanKey Take AwayWhy proper compatibility test of the sterile filtration system according to regulatory compliance standards is important for both the validation and ongoing monitoring to assure the quality and safety of the pharmaceutical product.OverviewSterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product.Why Should You AttendIt is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing filtration available and their application to your particular system. For example, the application of sterile filtration to use-point compressed air is discussed in detail.Areas Covered In This WebinarA review of the different filtration media is provided with the construction characteristics and properties of each detailed. A detailed description of a typical pharmaceutical sterile filtration system with its individual components is provided. Engineering schematics are included. Microbiology and particle retention mechanisms are discussed. Integrity testing methods are detailed as well as media qualification. Procedures for the sterilization of the filter are presented (SIP, autoclave, etc.).  The proper validation of sterile filtration is important to ensure that the filter will reproducibly remove undesirable components (bio-burden) while allowing passage of desirable components (drug product). The operating parameters of time, pressure and temperature are fully discussed as well as the filters potential effect on the product (compatibility, leachable, fibers, endotoxin, etc.).  Learning ObjectivesSterile filtration - Importance of QualitySterility Assurance of Sterile FiltrationSterile Filtration System DesignDiscussion of Different Filtration Media Properties and Retention Mechanisms Methods for Sterilization of FiltersValidation of Sterile Filter SystemsMicrobial Retention Challenge TestingIntegrity TestingProduct Compatibility TestingExtractable/Leachable TestingRegulatory RequirementsGMP TrainingCompatibility Test Who Will BenefitQuality Assurance PersonnelEnvironmental Monitoring AgenciesMicrobiology ProfessionalsManufacturing ProfessionalsValidation PersonnelEngineering ProfessionalsMaintenance PersonnelLevelIntermediate