Standard Guide for Development of Test Methods for the Counting and Sizing of Particulate Matter on the Surfaces of Single-Use Bioprocessing Equipment

Abstract

4.1 In the absence of standards pertaining to the measurement of particulate matter present on the surfaces of SUS, a longstanding practice is to adapt USP <788> (harmonized with Ph. Eur. 2.9.19 and JP 6.07) to SUS. However, USP <788> only describes test methods for the measurement of “particulate matter in injections.” The adaptation of these test methods written for final parenteral drug products to single-use bioprocessing equipment requires the addition of non-standardized procedures, and multiple assumptions are needed to transform USP <788> acceptance criteria for injectable drug products into acceptance criteria for SUS. 4.2 A complete assessment of the levels of subvisible and visible particulate matter present on the surfaces of SUS requires test methods specifically designed and validated for this purpose. In this guide, guidance is given on the development of “particle quantification test methods,” whereby a SUS is extracted with a test liquid (extraction procedure), the resulting extraction liquid converted into a test sample (test sample preparation procedure), and the test sample analyzed (particle measurement procedure) to determine the particle count and sizes in the test sample. 4.3 The requirements for validation of particle quantification test methods are given in Practice E3468.