1.1 本指南概述了在建立具有代表性的可浸出测试方法以检测材料是否与细胞培养基或制造工艺兼容时应考虑的最佳实践。本指南不取代或取代用于评估人体生物反应性的细胞生长试验，如USP<87>、USP<88>（塑料/弹性材料）或ISO 10993（医疗器械材料）。已通过这些测试的聚合物材料在正常工艺条件下可以浸出化合物，从而抑制某些细胞系的细胞培养生长。见参考文献 ( 1- 5. ) . 2. 代表制造条件的测试方法将有助于确定适合在制造过程中使用的材料。 1.2 本指南可能与生物制药制造、基于细胞的疗法、疫苗、基于细胞的诊断和其他领域有关。 1.3 以国际单位制表示的数值应视为标准值。 本标准不包括其他计量单位。 1.4 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.5 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》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 必须使用基于风险的方法来确定用于测试的细胞系、供试品和材料。应评估相关因素，以确定供试品是否代表预期用途。 5.2 如果材料与细胞培养基直接接触，无论接触时间长短，都应评估细胞培养兼容性。供试品可以是单一材料，也可以由多种材料组装而成。 5.3 一次性使用材料细胞培养兼容性评估的两个角度是供应商和最终用户的角度。据了解，供应商可以更好地获得一次性材料和材料制造过程，同时有限地获得代表性细胞系。供应商对材料的评估最好使用已知材料敏感性的可用细胞系进行测试。最终用户对材料的使用可能更加有限，但可以使用更具代表性的细胞系和工艺。因此，最终用户最好评估材料与工艺中特定细胞系的兼容性。 5.4 本指南概述了建立测试程序的最佳实践。 附录X1 概述了商用CHO细胞系的示例测试程序。

1.1 This guide outlines best practices to consider when setting up a representative leachable test method to detect if a material is compatible with cell culture media or manufacturing processes. This guide does not replace or supersede cell growth tests like USP <87>, USP <88> (plastic/elastomeric materials), or ISO 10993 (medical device materials), that are used in assessing biological reactivity in humans. Polymeric materials that have passed these tests have been found to leach compounds under normal process conditions that can inhibit cell culture growth for some cell lines. See Refs ( 1- 5 ) . 2 Test methods that are representative of the manufacturing conditions will help identify materials that are appropriate for use during manufacturing. 1.2 This guide may be relevant to biopharmaceutical manufacturing, cell-based therapeutics, vaccines, cell-based diagnostics, and other areas. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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. 1.5 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 ====== 5.1 A risk-based approach must be used to determine the cell lines, test articles, and materials used for testing. An evaluation of relevant factors should be made to determine if a test article is representative of the intended use. 5.2 Cell culture compatibility should be assessed if the material is in direct contact with cell culture medium regardless of duration of contact. Test articles can be of a single material or assembled from a multitude of materials. 5.3 Two perspectives to single-use material cell culture compatibility assessments are the supplier and the end user perspectives. It is understood that the supplier may have better access to single-use materials and material manufacturing processes, while having limited access to representative cell lines. Supplier assessment of materials are best tested using cell lines available that have shown known material sensitivity. The end users may have more limited access to materials but access to more representative cell lines and processes. Therefore assessment of compatibility of material with a specific cell line in a process is best evaluated by the end user. 5.4 This guide outlines best practices to establish test procedures. Appendix X1 outlines an example test procedure for a commercially available CHO cell line.