ASTM E3508 : 25

1.1 Information on the counts and types of particulate matter present on the surfaces of single-use bioprocessing equipment (single-use systems, SUS) is useful in the assessment of risks from particulate matter in the chosen bioprocess application of a SUS.

1.2 In this practice, a framework for reporting the particle count for both the subvisible (<100 µm) and visible (≥100 µm) size ranges commonly applied to particulate matter is provided. In addition, in this practice, a framework is provided for classifying and reporting the chemical identities and likely source classifications (intrinsic/extrinsic) of the types of visible particulate matter (≥100 µm) present on the interior (fluid-contacting) surfaces of a SUS.

1.3 This practice is applicable to the reporting of particulate matter data from SUS suppliers to end users (biopharmaceutical manufacturers) for the purpose of aiding in the determination of whether a SUS is fit for the purpose for the chosen bioprocess application.

1.4 This practice is applicable to the reporting of data on particulate matter present in SUS for quality control or process control purposes.

1.5 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.

1.6 This 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.

1.7 This 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.