YY/T 0567.6-2011 in English

YY/T0567的本部分规定了用于无菌加工过程的隔离器系统的要求,并对用于医疗产品无菌加工的隔离器系统提供了鉴定、消毒、确认、操作和控制指南。
本部分集中于维持无菌条件的隔离器系统的使用,并可能包括有害原材料的应用。
本部分并非取代或代替国家的管理要求,例如生产管理规范(GMPs)和/或部分属于国家或辖区的简略要求。

Scope

This part of YY/T 0567 specifies the requirements for isolator systems used in aseptic processing and provides guidance for the identification, sterilization, validation, operation and control of isolator systems used in aseptic processing of medical products. This section focuses on the use of isolator systems to maintain sterile conditions and may include the application of hazardous raw materials. This section is not intended to supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or abbreviated requirements that are partly national or jurisdictional.