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Sterile Filtration – What you need to know to meet Pharmaceutical Validation and Regulatory Requirements

Summary

  • 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

Overview

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.

Who should attend?

  • Quality Assurance
  • Environmental Monitoring
  • Microbiology
  • Manufacturing
  • Validation
  • Engineering
  • Maintenance

Roger Cowan

Expert

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. He has 36 years 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.

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