标准摘要
[中文适用范围]: 本文件规定了用于固体和液体剂型药物制剂的螺旋口玻璃瓶(veral)的设计、尺寸、材质和要求。螺旋口玻璃瓶适用于直接接触药物的内包装。本文件适用于药房使用的螺旋口玻璃瓶(veral)。它们与相应的封闭系统配合使用,用于包装非注射用固体和液体剂型药物制剂。注:内包装的性质和性能会严重影响药物在生产和储存过程中的效力、纯度、稳定性和安全性。 [外文原描述]: ISO 11418-3:2016 specifies the design, dimensions, material and requirements of screw-neck glass bottles (veral) for pharmaceutical preparations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. It is applicable to screw-neck glass bottles (veral) used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.
英文名称Containers and accessories for pharmaceutical preparations — Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms