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As biopharma processes have become increasingly sophisticated, so have the requirements for performing process-specific bacterial retention studies.

Pall has communicated extensively in recent years on new challenges surrounding the sterile filtration of so-called, ‘high-risk fluids’. Occurrences of failed bacterial retention studies (i.e. penetration of bacteria through the sterilizing grade filter when tested under the process conditions) are very rare. However, when penetration has been observed, Pall has reported that low surface tension fluids, specifically surfactant solutions, liposomes, lipids, emulsions and lipid-like solutions pose the greatest risk of allowing bacterial penetration through 0.2 µm rated, sterilizing grade filters.

To understand and address the new challenges associated with the sterile filtration validation of high-risk fluids, Express Pharma in association with Pall Corporation is organizing a webinar with the latest insights from industry experts on the following topics:

1) Sterile filter validation of complex fluids using QbD approach (Sterility Optimization through the Assessment of Risk – SOAR program)
2) Re-validation of sterile filtration with reference to PDA TR 26: Addressing process/product changes

Why Attend?
+ Understand how sterile filter validation tests are performed
+ Analyse how to mitigate product & process risks and maximize sterility assurance through Quality by Design
+ Get insights on risk analysis on the re-use of filters & decision-making in tests to be carried out
+ Hear how Pall labs are equipped to handle controlled/cytotoxic drug substances

Speakers:
+ Sudhakar Nagaraj, Principal Scientist: SLS – Global Regulatory and Validation Consulting Group, Pall Corporation
+ Wayne Lee, Ph.D., MBA, Senior Director, Global Validation Services and Laboratory Operations, Pall Corporation
+ Anand G Ibrahimpur, Senior Manager – APAC ROA, Global Validation Services and Laboratory Operations, Pall Corporation