保健产品的无菌加工.第4部分:就地清洗技术

[中文适用范围]： ISO 13408 的这一部分规定了适用于通过 aseotic 工艺制造无菌保健产品的设备的产品接触表面的就地清洁 (CIP) 工艺的一般要求，并提供了资格、验证、操作和控制方面的指导。 ISO 13408 的这一部分适用于将清洁剂输送到设计为与 CIP 兼容的设备内表面的过程，这些设备可能会与产品接触。 ISO 13408 的这一部分不适用于在洗衣机中拆卸和清洁设备的过程。 ISO 13408 的这一部分不会取代或取代国家监管要求，例如与特定国家或地区司法管辖区相关的良好生产规范 (GMP) 和/或药典要求。 [外文原描述]： ISO 13408-4:2005 specifies the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. ISO 13408-4:2005 is applicable to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product. ISO 13408-4:2005 is not applicable to processes where equipment is dismantled and cleaned in a washer. ISO 13408-4:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions.