Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Product Id : FDA13
Instructor : Roger Cowan
Jul 20, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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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.

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements:

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 give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing filtration available and their application to your particular system. For example, the application of sterile filtration to use-point compressed air is discussed in detail. A review of the different filtration media is provided with the construction characteristics and properties of each detailed. A detailed description of a typical pharmaceutical sterile filtration system with its individual components is provided. Engineering schematics are included. Microbiology and particle retention mechanisms are discussed.

Integrity testing methods are detailed as well as media qualification. Procedures for the sterilization of the filter are 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.

Learning Benefits :

  • 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 and Integrity Testing
  • Product Compatibility Testing and Extractable/Leachable Testing
  • Regulatory Requirements

Who Should Attend:

This webinar will provide valuable assistance to all personnel in

  • Quality Assurance
  • Environmental Monitoring Professionals
  • Quality Professionals
  • Laboratory Professionals
  • Chemical Department
  • Microbiology Department
  • Manufacturing Professionals
  • Engineers and Maintenance Professionals
Speaker Profile:

Roger Cowan is the owner of R Cowan Consulting Services LLC, which is a consulting firm which specializes chiefly in pharmaceutical contract manufacturing. He has been working in the field of pharmaceutical quality assurance and manufacturing for over 37 years, and in this time, he has held important positions in QC Laboratory, Quality Assurance, Manufacturing, Technical Services Validation, and Clinical Supply Manufacturing and Distribution.

He has taught microbiology courses at the Seneca College in Toronto, Canada, as part of the Pharmaceutical Technology Program. In addition, he has conducted webinars on various subjects, providing invaluable training to thousands of people across the nation.

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

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