Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Duration: 60 Minutes
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs to 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.
 Sterile Filtration Requirements
Instructor: Roger Cowan
Product ID: 500769

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:
A review of the different filtration media provided with the construction characteristics and properties of each will be discussed in this webinar. A detailed description of a typical pharmaceutical sterile filtration system with its individual components will be provided. Apart from these, engineering schematics are included and Microbiology and particle retention mechanisms, integrity testing methods, media qualification, procedures for the sterilization of the filter are also 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.

Objectives of the Presentation:
Objectives of the presentation are to discuss about the following topics:
  • 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 can Benefit:
This webinar will provide valuable assistance to all pharmaceutical personnel in:
  • Quality Assurance
  • Environmental Monitoring
  • Microbiology
  • Manufacturing
  • Validation
  • Engineering
  • Maintenance
$375
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  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Roger cowan has 32 years of experience in pharmaceutical R&D, manufacturing and QA management. He has established his own Consulting Services LLC, (http://www.pharmaconsultation.com/), Presently he is a Independent consulting to the pharmaceutical industry primarily in the area of pharmaceutical. His specialties 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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