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Sterile Filtration: Principles, Best Practices and New Developments

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Sterile Product Development

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 6))

Abstract

This chapter starts with a historical overview, description of sterile filtration applications, and performance requirements. Special attention is paid to the sterilizing final fill application for biotherapeutics with associated regulatory requirements. Sterile filters, their properties, manufacture, retention mechanisms, and economics are described. The chapter then covers how to develop, implement, and validate a sterile filtration process. Methods for filter selection, testing with scaled-down devices, sizing, system design, and operation are included. The use of filter bacterial challenge studies, system sterilization, and integrity testing for validation of the filtration process are covered. The chapter finishes with case studies in several areas the authors felt warranted special consideration.

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Authors and Affiliations

  1. EMD Millipore Corporation, Billerica, MA, USA

    Herb Lutz, Randy Wilkins & Christina Carbrello

Authors
  1. Herb Lutz
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  2. Randy Wilkins
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  3. Christina Carbrello
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Corresponding author

Correspondence to Herb Lutz .

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Editors and Affiliations

  1. Pharmaceutical R&D-BioTx Pharmaceutical, Chesterfield, Missouri, USA

    Parag Kolhe

  2. LifeCell Corporation, Bridgewater, New Jersey, USA

    Mrinal Shah

  3. Drug Product Engineering, Amgen, Thousand Oaks, California, USA

    Nitin Rathore

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© 2013 American Association of Pharmaceutical Scientists

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Lutz, H., Wilkins, R., Carbrello, C. (2013). Sterile Filtration: Principles, Best Practices and New Developments. In: Kolhe, P., Shah, M., Rathore, N. (eds) Sterile Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 6. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-7978-9_16

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