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Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Live Webinar | Roger Cowan | From: Oct 18, 2021 - To: Dec 31, 2021
Description

The sterile filtration process must be fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.

Areas Covered in the Webinar:-

  • 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

Topic Background:-

Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture as 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 are 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:-

This course will offer a broad review of:

  • Different filtration media with the construction characteristics and properties of each detailed
  • A typical pharmaceutical sterile filtration system with its components
  • Engineering schematics
  • Microbiology and particle retention mechanisms
  • Integrity testing methods and media qualification
  • Procedures for the sterilization of the filter (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 will be fully discussed along with the filter's potential effect on the product (compatibility, leachables, fibers, endotoxin, etc.). Microbial retention challenge testing is one of the validation requirements and the instructor will offer insights on the same.

At the end of the course, the instructor will present a compilation of all FDA/EU GMP regulatory guidances concerning sterile filtration. In keeping with these guidances and requirements, the responsibilities of the filter manufacturer vs. the filter used will be thoroughly analyzed.

Who Will Benefit:-

This webinar will provide valuable assistance to all personnel in:

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

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Instant Download
$229
Recorded Session
$229
DVD
$249
Recorded Session & DVD
$389
E-book(Pdf)
$229
Recorded & E-book (Pdf)
$379
DVD & E-book (Pdf)
$389
Unlimited Access
$1599




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