Sterile Filtration of Pharmaceutical Products – Validation and Regulatory Requirements 2019

Topics

• Sterility assurance of sterile filtration
• Sterile filtration—importance of quality
• Discussion of different filtration media properties and retention mechanisms
• Sterile filtration system design
• Validation of sterile filter systems
• Methods for sterilization of filters
• Integrity testing
• Microbial retention challenge testing
• Extractable/leachable testing
• Product compatibility testing
• FDA/EU GMP regulatory requirements

Who should Attend

• Environmental Monitoring Departments
• Quality Assurance Departments
• Manufacturing Departments
• Microbiology Departments
• Engineering Departments
• Validation Departments
• Maintenance Departments