Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
|Date||:||27th June 2019|
|Time||:||10:00 AM PST | 01:00 PM EST|
It 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 offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.
Why Should You Attend:
This session 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 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
- Regulatory Requirements
Who Will Benefit:
- Quality Assurance
- Environmental Monitoring
Roger Cowan is the founder and owner of R Cowan Consulting Services LLC. Roger has more than 30 years of direct experience in pharmaceutical quality assurance and manufacturing at major pharmaceutical companies in Canada and the U.S. 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. His experience covers management of the Clinical Supplies Manufacturing Facility and handling GMP and ISO audits from both domestic and international regulatory agencies. He has extensive experience in GMP audits covering various suppliers and contract manufacturing organizations.
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.