Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements

Roger-Cowan
Speaker: Roger Cowan
Owner of R Cowan Consulting Services LLC
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Duration: 60 Minutes
Product Code: 300036
Level: Intermediate
Key Take Away

Why proper compatibility test of the sterile filtration system according to regulatory compliance standards is important for both the validation and ongoing monitoring to assure the quality and safety of the pharmaceutical product.

Overview

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.

Areas Covered in this Webinar

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 compliance trainings concerning sterile filtration are presented. Related to this; the responsibilities of the filter manufacturer vs. the filter user is fully discussed.


Learning Objectives
  • 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
  • GMP Training
  • Compatibility Test

Who Will Benefit
  • Quality Assurance Personnel
  • Environmental Monitoring Agencies
  • Microbiology Professionals
  • Manufacturing Professionals
  • Validation Personnel
  • Engineering Professionals
  • Maintenance Personnel
Speakers Profile
Roger Cowan

Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. Roger has 36 years of experience in pharmaceutical quality assurance and manufacturing. 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. 

Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toronto, Canada. 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.

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