YY/T 0567.4-2011 in English

YY/T0567的本部分规定了对按无菌过程生产医疗保健产品的设备产品接触表面进行在线清洗(CIP)过程的基本要求,并提供了鉴定、确认、操作和控制的指南。
本部分适用于在设计为与CIP兼容、可能与产品接触的设备内表面使用清洁剂的过程。
本部分不适用于拆卸设备并在清洗机中清洗的过程。
本部分不代替或取代国家法规要求,如归属于特定国家或地区的生产管理规范(GMP)和/或药典要求等。

Scope

This part of YY/T 0567 specifies the basic requirements for the cleaning-in-place (CIP) process of product contact surfaces of equipment used to produce medical care products according to aseptic processes, and provides guidance for identification, validation, operation and control. This section applies to processes using cleaning agents on internal surfaces of equipment designed to be CIP-compatible and that may come into contact with product. This section does not apply to the process of disassembling equipment and cleaning it in a cleaning machine. This section does not replace or supersede national regulatory requirements, such as good manufacturing practices (GMP) and/or pharmacy requirements belonging to a specific country or region.