标准编号：ISO 8362-5:2016
中文名称：注射容器及附件 第5部分：注射小瓶用冷冻干燥瓶塞
英文名称：Injection containers and accessories — Part 5: Freeze drying closures for injection vials
发布日期：2016-02
标准范围
This part of ISO 8362 specifies the shape, dimensions, material, performance requirements andlabelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which isused in connection with the freeze drying (or lyophilization) of drugs and biological materials.The dimensional requirements are not applicable to barrier-coated closures.Closures specified in this part of ISO 8362 are intended for single use only.NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storagecan be strongly affected by the nature and performance of the primary packaging.
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