标准编号：ISO 13408-6:2005
中文名称：健保产品的防腐处理-第6部份： 隔离系统
英文名称：Aseptic processing of health care products — Part 6: Isolator systems
发布日期：2005-06
标准范围
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.
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