Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because 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 is 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.
Why Should you Attend:
A review of the different filtration media provided with the construction characteristics and properties of each will be discussed in this webinar. A detailed description of a typical pharmaceutical sterile filtration system with its individual components will be provided. Apart from these, engineering schematics are included and Microbiology and particle retention mechanisms, integrity testing methods, media qualification, procedures for the sterilization of the filter are also presented (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 are fully discussed as well as the filters potential effect on the product (compatibility, leachables, fibers, endotoxin, etc.). Microbial retention challenge testing is one of the validation requirements. Finally, a compilation of all FDA/EU GMP regulatory guidances concerning sterile filtration are presented. Related to this; the responsibilities of the filter manufacturer vs. the filter user is fully discussed.
Objectives of the Presentation:
Objectives of the presentation are to discuss about the following topics:
Who can Benefit:
- 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
This webinar will provide valuable assistance to all pharmaceutical personnel in:
- Quality Assurance
- Environmental Monitoring