USP <660>玻璃容器
继先前发布的USP General Chapter <660> Containers – Glass草案之后，该章节的最终版本于2023年10月1日发布并正式生效。具体来说，对General Chapter <660>的修订将玻璃类型定义从“基于成分”更改为“基于性能”。
为了使玻璃类型与玻璃成分脱钩，原则上，所有通过Type I测试的玻璃可用于需要Type I玻璃的药物，如其专论中的包装部分所述。
此前，<660>将Type I定义为硼硅酸盐玻璃，Type II定义为经处理的钠钙硅酸盐，Type III定义为钠钙硅酸盐。现在，General Chapter <660>通过性能特征定义了玻璃的I、II和III型，允许根据其水解阻力考虑其他成分作为I、II和III型玻璃。然而，测试程序或验收标准没有变化。
此外，将对目前规定的特定玻璃类型的14个专论进行修订，在专论的包装部分添加“首选”一词。例如，当前要求“Type I玻璃”的专论将被修订为“首选Type I玻璃”。在相关专论中添加“首选”一词意味着首选使用指定的玻璃，但不是必需的。这一修订将为制造商在选择包装方面提供更多灵活性，并为新的或不同类型的包装获得批准铺平道路（例如铝硅酸盐玻璃）。
需要注意的是，两个药典章节-USP <660> Containers – Glass和Ph. Eur. 3.2.1 Glass containers for pharmaceutical use-目前在这方面并不协调统一。欧洲药典仍然引用Type 1玻璃容器的硼硅酸盐玻璃（“中性玻璃”）。
如需更多信息，请参见USP Chapter <660> Containers – Glass。
以下是原文
Following the previously issued draft for USP General Chapter <660> Containers – Glass, the final version of the chapter was published and made official on 1st October 2023. In particular, the revision to General Chapter <660> changed the "composition based" glass type definition to one that is "performance based".
To disconnect the Type designation from the glass composition, in principle all glasses that pass the test for Type I can be used for drugs that require Type I glass as per the packaging section in their monographs.
Previously, <660> defined Type I as borosilicate glass, Type II as treated soda-lime silica, and Type III as soda-lime silica. Now, General Chapter <660> instead defines glass Types I, II, and III by performance characteristics, allowing for additional compositions to be considered Type I, II, and III glass based on their hydrolytic resistance. However, there are no proposed changes to test procedures or acceptance criteria.
In addition, revisions will be made to 14 monographs that currently prescribe a specific glass type by adding the word “preferably” in the packaging section of the monograph. For example, a current monograph that requires “Type I glass” would be revised to state “preferably of Type I glass.” The addition of the word “preferably” to the monographs at issue means that the use of the glass specified is preferred, but not required. This revision will give manufacturers additional flexibility in their choice of packaging and pave the way for new or different types of packaging to be approved (e.g. aluminosilicate glass).
It is important to notice that the two compendial chapters – USP <660> Containers – Glass and Ph. Eur. 3.2.1 Glass containers for pharmaceutical use – are curently not harmonized in this point. The Ph. Eur. still refers to borosilicate glass (“neutral glass”) for Type 1 glass containers.
For more information please see USP Chapter <660> Containers – Glass.
