Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
保健产品的无菌加工 - 第2部分:过滤(ISO 13408-2:2003)
发布日期:
2011-06-29
废止日期:
2018-03-21
ISO 13408-2:2003规定了作为无菌加工保健产品的一部分的过滤消毒的要求。它还提供过滤用户的指导,以了解灭菌过滤过程的设置,验证和常规操作的一般要求,用于保健产品的无菌加工。
ISO 13408-2:2003不适用于去除病毒。灭菌过滤不适用于含有大于过滤器孔径(如细菌全细胞疫苗)的有效成分的颗粒的流体
ISO 13408-2:2003 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products.
ISO 13408-2:2003 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines).