1.1 在本指南中，描述了颗粒定量测试方法的开发指南，该方法用于确定生物制药生产过程中应用的一次性生物加工设备（一次性系统（SUS））表面上存在的颗粒物质的数量和尺寸。 1.2 在颗粒定量测试方法中，应用液体从SUS表面提取颗粒物质，随后用颗粒测量技术分析提取物以确定颗粒计数和尺寸。 1.3 本指南仅限于应用药典中描述的肠胃外药物产品的颗粒测量技术:光阻（LO）、膜显微镜（MM）和流动成像（FI）。 1.4 在本指南中，亚可见（10µm至100µm）和可见（ ≥ 100µm)颗粒物。 1.5 有关微粒定量检测方法的验证要求，请参见实践 E3468 . 1.6 单位- 以SI单位表示的值应被视为标准。本标准不包括其他计量单位。 1.7 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。 1.8 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。======意义和用途====== 4.1 在缺乏与SUS表面存在的颗粒物测量相关的标准的情况下，长期的实践是将USP<788>（与Ph.Eur.2.9.19和JP 6.07协调）适应SUS。然而，USP<788>仅描述了测量“注射剂中颗粒物”的测试方法。将这些为最终胃肠外药品编写的测试方法适用于一次性生物加工设备需要添加非标准化程序，并且需要多个假设才能将USP<788>注射用药品的验收标准转化为SUS的验收标准。 4.2 对SUS表面存在的不溶性和可见颗粒物水平的完整评估需要为此目的专门设计和验证的测试方法。在本指南中，对“颗粒定量测试方法”的开发提供了指导，其中用测试液体提取SUS（提取程序），将所得提取液体转化为测试样品（测试样品制备程序），并分析测试样品（颗粒测量程序）以确定测试样品中的颗粒计数和尺寸。 4.3 在实践中给出了颗粒定量测试方法验证的要求 E3468 .

1.1 In 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. 1.2 In 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. 1.3 This 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). 1.4 In this guide, the commonly applied size classifications for subvisible (10 µm to 100 µm) and visible ( ≥ 100 µm) particulate matter are adopted. 1.5 For the validation requirements for particle quantification test methods, see Practice E3468 . 1.6 Units— The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. 1.7 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. 1.8 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. ====== Significance And Use ====== 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 .