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