ISO 13408-4:2005 保健产品的无菌加工.第4部分：就地清洗技术

标准编号：ISO 13408-4:2005

中文名称：保健产品的无菌加工.第4部分：就地清洗技术

英文名称：Aseptic processing of health care products — Part 4: Clean-in-place technologies

发布日期：2005-11

标准范围

ISO 13408-4:2005规定了适用于无菌处理生产无菌保健产品的设备产品接触面的就地清洁（CIP）工艺的一般要求，并提供了鉴定、验证、操作和控制指南。ISO 13408-4:2005适用于将清洁剂输送至与CIP兼容的设备内表面的工艺，这些设备可能与产品接触。ISO 13408-4:2005不适用于在洗衣机中拆卸和清洁设备的过程。ISO 13408-4:2005不取代或取代国家监管要求，例如与特定国家或地区管辖区有关的良好生产规范（GMP）和/或药典要求。

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.

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