1.1This practice describes the requirements for development, and qualification of procedures for the effective liquid extraction of particulate matter from the surfaces of single-use bioprocessing equipment (single-use systems (SUS)) applied in biopharmaceutical manufacturing processes. The extraction generates a suspension of particulate matter in liquid which makes the particulate matter readily available for analytical characterization.
1.2Extraction is the first procedure applied when implementing a particle quantification test method for determination of the count and sizes of particulate matter present on the surfaces of SUS.
1.3The overall development and validation of particle quantification test methods for SUS are described in detail in Guide E3466 and Practice E3468.
1.4This practice is also applicable to individual components that may be assembled into SUS and assemblies thereof.
1.5The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6This 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.
1.7This 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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