ISO 13408-6-2005 保健产品的无菌加工.第6部分:隔离器系统

标准号：ISO 13408-6-2005
中文标准名称：保健产品的无菌加工.第6部分:隔离器系统
英文标准名称：Aseptic processing of health care products - Part 6: Isolator systems
标准类型：C50
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：C50
国际标准分类号：11.080.01
适用范围：This part of ISO 13408 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. This part of ISO 13408 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials. 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 in particular to national or regional jurisdictions.