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Sterile Filtration of Pharmaceutical Products: Validation and Regulatory Requirements

Sterile Filtration of Pharmaceutical Products: Validation and Regulatory Requirements

  Duration: 60 Minutes

Faculty: Roger Cowan      Level: Intermediate      Course ID: 1162


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:

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 (bio-burden) 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, leachable, 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 is presented.   Related to this; the responsibilities of the filter manufacturer vs. the filter user is fully discussed.

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:

  • QA/QC
  • Pharma Industries and Staff
  • Pharma or Drug Manufacturers
  • Drug Laboratories
  • Med Professionals
  • Environmental Monitoring
  • Microbiology
  • Manufacturing
  • Engineering

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Sr. Pharmaceutical Consultant