ISO 13408-6:2021 保健产品的无菌处理 第6部分：隔离器系统

标准编号：ISO 13408-6:2021

中文名称：保健产品的无菌处理 第6部分：隔离器系统

英文名称：Aseptic processing of health care products — Part 6: Isolator systems

发布日期：2021-04

标准范围

本文件规定了与卫生保健产品无菌加工和细胞基卫生保健产品加工相关的隔离器系统的规范、选择、鉴定、生物去污、验证、操作和控制的要求，并提供了指导。本文件未规定受限访问屏障系统（RABS）的要求。本文件不取代或取代国家监管要求，如与国家或地区司法管辖区有关的良好生产规范（GMP）和/或药典要求。本文件未规定用于无菌检测的隔离器的要求；然而，本文件中的一些原则和信息可能适用于本应用。本文件未定义生物安全控制要求。

This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.This document does not specify requirements for restricted access barrier systems (RABS).This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.This document does not define biosafety containment requirements.

标准预览图