Sterile Filtration of Pharmaceutical Products – Validation and Regulatory Requirements

Proper validation of sterile filtration helps to ensure that the filter will reproducibly remove undesirable components or bioburden and will allow the passage of desirable components such as drug products. Thus, it is important that the sterile filtration process is completely understood and is properly validated for particular applications. The process requirements and validation needs differ based on the filtration requirement.

This webinar, by expert speaker Roger Cowan, will provide you with a comprehensive understanding of sterile filtration process, with a focus on the different types of sterilizing filtration available and their application to your particular system. It will discuss in detail the application of sterile filtration to use-point compressed air. The session will also discuss operating parameters of time, pressure and temperature as well as the filter’s potential effect on the product—compatibility, fibers, leachable, endotoxin, etc.

Further, the session will review different filtration media and will discuss in detail the construction characteristics and properties of each. You will get a detailed description of a typical pharmaceutical sterile filtration system with its individual components, including a discussion on engineering schematics.

Additionally, Roger will discuss microbiology and particle retention mechanisms, integrity testing methods, media qualification, and procedures for sterilization of the filter (SIP, autoclave, etc.). You will learn about the FDA/EU GMP regulatory guidance regarding sterile filtration and understand the responsibilities of the filter manufacturer vs. the filter user.

Areas Covered in the Session :

• 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
• FDA/EU GMP regulatory requirements

Who Should Attend:

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

Course Director: ROGER COWAN ‎

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 37 years experience in pharmaceutical quality assurance and manufacturing.  In his career, Roger has held various manager / director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution.  Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toronto, Canada. Roger’s 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.