Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
卫生保健产品的无菌加工 - 第4部分:现场清洁技术(ISO 13408-4:2005)
发布日期:
2011-06-29
实施日期:
2011-06-29
ISO 13408-4:2005规定了通过无菌处理应用于制造无菌保健产品的设备的产品接触表面的现场清洁(CIP)工艺的一般要求,并提供有关资质,验证,操作和控制的指导。
ISO 13408-4:2005适用于将清洁剂输送到设计为与CIP兼容的设备的内表面的过程,CIP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并不取代或替代国家监管要求,例如与特定国家或地区管辖区有关的良好生产规范(GMP)和/或协议要求
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.