标准摘要
[中文适用范围]： 本部分规定了用于药物和生物材料冷冻干燥（或称真空冷冻干燥）的注射剂瓶塞的形状、尺寸、材料、性能要求和标签。不适用于屏障密封塞。根据ISO 8362-1和ISO 8362-4所述的此类塞子，仅限一次性使用。 本部分规定的药用橡胶塞适用于冷冻干燥过程中需要与注射剂瓶配合使用的场合。 注：原辅料在生产和储存过程中的效价、纯度、稳定性和安全性可能会因主要包装的性质和性能而受到严重影响。 [外文原描述]： ISO 8362-5:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362‑1 and ISO 8362‑4, which is used 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 storage can be strongly affected by the nature and performance of the primary packaging.
英文名称Injection containers and accessories — Part 5: Freeze drying closures for injection vials