This presentation explores the validation of sterilization by filtration as a critical step in aseptic pharmaceutical processing. Sterile filtration ensures product safety by physically removing microorganisms without altering product quality, and it is guided by regulatory frameworks such as FDA guidance, ISO 13408-2, and PDA Technical Report 26. Key quality attributes—including filter compatibility, adsorption, extractables and leachables, and microbial retention—are examined to highlight the factors that influence filter performance. Validation methodologies, including microbial challenge testing with Brevundimonas diminuta, integrity testing, and worst-case condition assessments, are discussed to emphasize the importance of robust study design. Through careful validation and ongoing monitoring, sterile filtration provides reliable assurance of sterility, supporting both regulatory compliance and patient safety.
This presentation will give you a clear understanding of how sterile filtration is validated and why it is essential for aseptic processing in pharmaceutical manufacturing. You will learn about regulatory expectations, key quality attributes, and practical validation strategies that ensure patient safety and product quality. Whether you work in quality assurance, regulatory affairs, process development, or manufacturing, this session will provide valuable insights into risk mitigation, compliance, and best practices for one of the most critical steps in sterile product production.
From this webinar you will learn:
• Learn how sterile filtration protects patients by keeping medicines safe from harmful microbes.
• Understand the key steps and tests used to prove that filtration really works.
• Gain insight into regulatory expectations and why validation is required.
• Walk away with practical knowledge that applies across pharmaceutical development and manufacturing.