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

标准号：ISO 13408-4-2005
中文标准名称：保健产品的无菌加工.第4部分:就地清洗技术
英文标准名称：Aseptic processing of health care products - Part 4: Clean-in-place technologies
标准类型：C53
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C53
国际标准分类号：11.080.01
适用范围：This part of ISO 13408 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 aseotic processing and offers guidance on qualification, validation, operation and control. This part of ISO 13408 is applicable to processes where cleaning agents arc delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product. This part of ISO 13408 is not applicable to processes where equipment is dismantled and cleaned in a washer. This part of ISO 13408 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.