Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Why Should You Attend:

This course will offer a broad review of:

• Different filtration media with the construction characteristics and properties of each detailed
• A typical pharmaceutical sterile filtration system with its individual components
• Engineering schematics
• Microbiology and particle retention mechanisms
• Integrity testing methods and media qualification
• Procedures for the sterilization of the filter (SIP, autoclave, etc.)

The proper validation of sterile filtration is important to ensure that the filter will reproducibly remove undesirable components (bioburden) while allowing passage of desirable components (drug product). The operating parameters of time, pressure and temperature will be fully discussed along with the filter's potential effect on the product (compatibility, leachables, fibers, endotoxin, etc.). Microbial retention challenge testing is one of the validation requirements and the instructor will offer insights on the same.

At the end of the course, the instructor will present a compilation of all FDA/EU GMP regulatory guidances concerning sterile filtration. In keeping with these guidances and requirements, the responsibilities of the filter manufacturer vs. the filter user will be thoroughly analyzed.

Areas Covered in the Webinar:

• Sterile Filtration - Importance of Quality
• Sterility Assurance of Sterile Filtration
• Sterile Filtration System Design
• Discussion of Different Filtration Media Properties and Retention Mechanisms
• Methods for Sterilization of Filters
• Validation of Sterile Filter Systems
• Microbial Retention Challenge Testing
• Integrity Testing
• Product Compatibility Testing
• Extractable/Leachable Testing
• Regulatory Requirements

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

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

Roger Cowan
Pharmaceutical Consultant, R Cowan Consulting Services LLC

Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 35 years' experience in pharmaceutical quality assurance and manufacturing. In his career, Mr Cowan has held various manager / director positions in quality assurance, QC laboratory, technical services validation, manufacturing, and clinical supply manufacturing and distribution. He has taught courses in microbiology at Seneca College (pharmaceutical technology program) in Toronto, Canada.

His areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US / International regulatory requirements, regulatory submissions, and quality assurance/control.

Topic Background:

Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture as the filtration process provides the assurance of sterility in the finished drug product. Therefore, the design, validation and ongoing monitoring of a sterile filtration system are essential for assuring the quality and safety of the pharmaceutical product. Proper understanding and testing of the sterile filtration system according to international regulatory standards is important for both the validation and ongoing monitoring of the system.

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