1.1In this guide, guidance on the development of particle quantification test methods that determine the count and sizes of particulate matter present on the surfaces of single-use bioprocessing equipment (single-use systems (SUS)) applied in biopharmaceutical manufacturing processes is described.
1.2In particle quantification test methods, liquid is applied to extract particulate matter from the surfaces of SUS, and the extract is subsequently analyzed with a particle measurement technique to determine particle count and sizes.
1.3This guide is limited to the application of the particle measurement techniques described in the pharmacopoeia for parenteral drug products: light obscuration (LO), membrane microscopy (MM), and flow imaging (FI).
1.4In this guide, the commonly applied size classifications for subvisible (10 µm to 100 µm) and visible (≥100 µm) particulate matter are adopted.
1.5For the validation requirements for particle quantification test methods, see Practice E3468.
1.6Units-The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.
1.7This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.8This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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