Containers and accessories for pharmaceutical preparations — Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
药物制剂的容器和配件 - 第7部分:用于液体剂型的玻璃管制螺杆瓶
发布日期:
2016-06-13
ISO 11418-7:2016规定了药物制剂用螺旋颈瓶的设计、尺寸、材料和要求。螺旋颈瓶适用于与药物直接接触的主包装。
它适用于无色或琥珀色玻璃瓶,由硼硅酸盐或钠钙硅玻璃制成,由玻璃管制成,用于医药产品的包装、储存或运输。
注:药物在生产和储存期间的效力、纯度、稳定性和安全性可能会受到原包装的性质和性能的强烈影响。
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.