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Particulate Matter in Sterile Parenteral Products

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Sterile Product Development

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

Abstract

Particulate matter, visible or subvisible, in sterile parenteral products is regarded as a critical quality attribute, impacting safety of the product. Particles can arise from many sources foreign, intrinsic, or inherent to the product, the latter having particular emphasis for biopharmaceuticals. This chapter discusses the nature of these particles, the safety concerns behind the need to control them, and the various techniques available to monitor them. The concern with inherent proteinaceous particles in biopharmaceuticals has led to a large amount of research in this area and the development of a number of novel techniques and applications. The chapter also covers some special topics of current interest including the definition of “essentially free,” topics related to the measurement and control of subvisible particles under 10 μm in biopharmaceuticals, the new USP<787> chapter, as well as guidance for addressing particles related regulatory queries.

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  1. Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc., 700 Chesterfield Parkway West, Chesterfield, MO, 63017, USA

    Satish K. Singh

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  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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Singh, S.K. (2013). Particulate Matter in Sterile Parenteral Products. 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_14

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