1.1 本指南旨在作为指南的补充 E2500 . 1.2 本指南适用于指南中所述的一系列制造系统 E2500 ，具体而言，用于制造制药和生物制药产品的一次性系统或一次性和传统组件的混合物的所有元素，包括:建筑材料、组件、组件、歧管、配套公用设施、相关过程监测和控制系统、自动化系统，以及可能影响产品质量和患者安全的受控环境。 1.3 本指南适用于现有系统制造系统设计变更的实施。 它可以用于从临床到商业规模的持续改进和操作变化。 1.4 为简洁起见，在本指南的其余部分中，一次性使用系统称为SUS。 1.5 该方法可由最终用户、SUS供应商和供应链中的原材料次级供应商应用。 1.6 本指南不适用于包装、主要容器、组合产品（由药物、装置或生物产品的任何组合组成的产品）或装置的一次性使用技术。 1.7 本指南不涉及具体的当地要求，这些要求仍由最终用户负责。 1.8 本指南不涉及员工健康和安全、环境或其他良好工程和制造规范（GXP）要求。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和健康实践，并确定监管限制的适用性。 ====意义和用途====== 5.1 本指南中所述方法的应用旨在满足国际监管期望，确保SUS适合其预期用途，并满足采购、供应、设计、规范、安装、操作和性能要求。 5.2 本指南中描述的方法适用于FDA倡议中介绍的概念和原则，即面向21世纪的药物cGMP–一种基于风险的方法。它支持并符合ICH Q7、ICH Q8（R2）、ICH Q9和ICH Q10中FDA工业指导、过程验证:一般原则和实践中描述的框架。 5.3 本指南包括第66号PDA技术报告中开发的概念。 5.4 本指南可以单独使用，也可以与ASTM国际组织发布的其他ASTM委员会E55拟议标准一起使用。 5.5 供应商和最终用户应使用有关可提取物、可浸出物、颗粒物和完整性测试/泄漏检测、生物相容性和原材料的具体标准实践，并将其应用于自己的制造工艺设施。

1.1 This guide is intended as a complement to Guide E2500 . 1.2 This guide is applicable to the range of manufacturing systems described in Guide E2500 , specifically all elements of single-use systems, or hybrids of single-use and traditional components, used for the manufacturing of pharmaceutical and biopharmaceutical products, including: materials of construction, components, assembly, manifolds, supporting utilities, associated process monitoring and control systems, automation systems, and controlled environment that have the potential to affect product quality and patient safety. 1.3 This guide is applicable for the implementation of changes to manufacturing system design for existing systems. It may be used for continuous improvement and changes in operation from clinical through to commercial scale. 1.4 For brevity, single-use systems are referred to as SUS throughout the rest of this guide. 1.5 The approach may be applied by the end user, the supplier of SUS, and raw materials sub-suppliers further back in the supply chain. 1.6 This guide is not intended to apply to the use of single-use technology for packaging, primary containers, combination products (products composed of any combination of a drug, device, or biological product) or devices. 1.7 This guide does not address specific local requirements, which remain the responsibility of the end user. 1.8 This guide does not address employee health and safety, environmental, nor other good engineering and manufacturing practices (GXP) requirements. 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 and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== 5.1 Application of the approach described within this guide is intended to satisfy international regulatory expectations in ensuring that SUS are fit for their intended use and to satisfy requirements for sourcing, supply, design, specification, installation, operation, and performance. 5.2 The approach described in this guide applies concepts and principles introduced in the FDA initiative, Pharmaceutical cGMP’s for the 21st Century – A Risk-Based Approach. It supports and is consistent with the framework described in FDA Guidance for Industry, Process Validation: General Principles and Practices, in ICH Q7, ICH Q8 (R2), ICH Q9, and ICH Q10. 5.3 This guide includes concepts developed in the PDA Technical Report No. 66. 5.4 This guide may be used independently or in conjunction with other ASTM Committee E55 proposed standards to be published by ASTM International. 5.5 Specific standard practices about extractables, leachables, particulate matter, and integrity testing/leak detection, biocompatibility, and raw materials as available should be used by suppliers and end users and applied to their own manufacturing process facilities.