药剂容器及附件 第7部分:液体药剂用管制玻璃螺口瓶

[中文适用范围]： ISO 11418的本部分规定了药物制剂用螺纹口瓶的设计、尺寸、材料和要求。 螺纹口瓶适用于与药物直接接触的初级包装。 ISO 11418 的这一部分适用于由硼硅酸盐或钠钙玻璃制成的无色或琥珀色玻璃瓶，由玻璃管制成，旨在用于药品的包装、储存或运输。 注：药物在生产和储存过程中的效力、纯度、稳定性和安全性会受到初级包装的性质和性能的强烈影响。 [外文原描述]： ISO 11418-7:2016 specifies the design, dimensions, material and requirements of screw-neck vials for pharmaceutical preparations. Screw-neck vials are applicable to primary packs used in direct contact with a drug. It applies to colourless or amber glass vials made from borosilicate or soda-lime-silica glass, made from glass tubing and intended to be used in the packaging, storage or transportation of pharmaceutical products. NOTE The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.