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USP Draft Chapters on Glass Containers <660> and <1660>
USP玻璃容器<660>和<1660>章节草案
The USP Packaging and Distribution Expert Committee is proposing the revision of the USP glass container chapters <660> Containers-Glass and <1660> Evaluation of the Inner Surface Durability of Glass Containers.
USP包装和销售专家委员会正提议修订USP玻璃容器章节<660>容器-玻璃和<1660>玻璃容器内表面耐受度评估。
The drafts of these two chapters have been published for public comment in Pharmacopeial Forum (PF) 43(3) [May–Jun. 2017]. Deadline for comments is July 31, 2017.
这两章节的草案已经发布在药典论坛43（3）【2017年5-6月】上征求公众意见，截止日期为2017年7月31日。
The revision of <660> is proposed 'to clarify the intent of the chapter and provide additional information to aid in the execution of the Surface Glass Test, Glass Grains Test, and Surface Etching Test'.
<660>的修订版本提议“澄清该章节的目的，提供更多信息协助实施表面玻璃测试、玻璃颗粒测试和表面蚀刻测试”。
USP says that 'none of the proposed revisions will change the chapter's requirement. However, there will be a revision proposal in 2018 that is meant to modernize tests, test methods, and specifications within the chapter, and will be a high-impact revision'.
USP说“所提议的修订不会改变章节的要求。但是，在2018年会有一个修订提议，这意味着现代化该章节内的测试项目、检测方法和质量标准，会是一次具有高度影响性的修订。”
Listed below are the key changes being proposed for <660>:
以下列出了<660>所提议的关键变化：
The chapter title has been changed to “Glass Containers Used in Pharmaceutical Packaging/Delivery Systems”;
该章节标题修改为“药品包装/给药系统用玻璃容器”；
A Scope section has been added;
增加了范围部分；
Table 1 and Table 2 have been consolidated into on
e table which denotes the specifications for the Surface Glass Test, Glass Grains Test, and Surface Etching Test for a glass container to be classified as Type I, II, or III;
表1和表2整合成为一个表格，在其中标注了表面玻璃测试、玻璃颗粒测试和表面蚀刻测试将被分类为I类、II类和III类。
Additional requirements for the autoclave used for the various tests have been added to the chapter;
章节中增加了用于不同测试的灭菌器的额外要求；
The list of ancillary equipment required to execute the chapter has been expanded;
扩充实施该章节的辅助设备清单；
The Purified Water requirement has been aligned with the Ph. Eur. General Chapter 3.2.1 'Glass Containers for Pharmaceutical Use';
将纯化水要求与欧洲药典3.2.1“药用玻璃容器”保持一致；
Additional information on the autoclaving procedure has been added to the chapter, including Reference temperature curve, autoclave calibration, and routine autoclave runs (see also Ph. Eur. Draft Chapter 3.2.1 'Glass containers for pharmaceutical use');
在章节中增加了灭菌程序更多信息，包括参考温度曲线、灭菌校正和常规灭菌流程（也参见欧洲药典3.2.1章节草案“药用玻璃容器”）；
Additional information on how to titrate the test and blank samples has been added to the chapter.
在章节中增加了如何滴定样品和空白样品的更多信息。
Additionally, the Expert Committee is proposing the revision of <1660> to 'clarify the intent of the chapter and provide additional information to aid in the understanding of the factors that affect the inner surface durability of a glass container'.
另外，专家委员会提议修订<1660>以“澄清该章节的目的，提供更多信息以助于理解影响玻璃容器内表面耐受力的因素”。
Listed below are the key changes being proposed to <1660>:
提议对<1660>的关键修订列出如下：
The chapter title is changed to “Glass Containers Used in Pharmaceutical Packaging/Delivery Systems: Manufacture and Evaluation of the Inner Surface Durability”;
章节标题改为“药物包装/给药体系用玻璃容器：生产和内表面耐受性评估”；
The Purpose section is changed to an Introduction;
目的部分改为介绍；
Table 1 is added to include aluminosilicate glass;
增加表1，在其中包括硅酸铝玻璃；
The Glass Surface Chemistry section is revised and new equations added;
玻璃表面化学部分进行了修订，加入了新公式；
A new section is added on Glass Particles and Flakes;
增加玻璃颗粒和玻璃碎片新部分；
A new section is added on Glass Delamination including a clarification that examinations regarding Delamination are intended to be conducted by the pharmaceutical manufacturer, not the glass manufacturer or converter;
加入玻璃分层章节，包括澄清关于分层的检测应由药品生产商进行检测，而不是由玻璃生产商或成型商检测；
New sections are added on Critical Parameters in the Autoclave Loading Procedure, Trays, Autoclave Loads, Sample Types and Sizes, and Autoclave Calibration and Load Mapping.
增加灭菌器装载程序、托盘、灭菌器装载量、样品类型和样品数量，以及灭菌校正和装载分布试验的关键参数部分。
Furthermore, minor editorial changes have been made to update the two chapters to current USP style.
另外，还对两个章节进行了编辑性修订以适应目前的USP形式。
A workshop on Modernization of USP Packaging Standards for Glass and Elastomeric Components, will take place from June 19–20, 2017 at the USP Meetings Center in Rockville, Maryland, to discuss these two proposals.
2017年6月19-20日，将在马里兰罗克维尔USP会议中心召开USP玻璃和橡胶成份包装标准现代化培训讲座。
The USP also provided a briefing list in PF 43(3) which includes monographs and/or chapters that both reference the general chapters under revision and require revision to keep references to the General Chapter accurate. The USP says that 'other monographs and/or chapters may also be listed, even where the reference to the General Chapter remains unchanged, as additional notice to stakeholders where there is believed to be potential for the change in the general chapter itself to affect pass-fail determinations for particular monograph articles'.
USP还在PF43(3)中给出一个简要的清单，在其中包括了正在修订中或需要修订的章节和/或各论，以保证引用准确。USP说“即使对通则的引用保持未变也一样，可能会也列出其它各论和/或章节，作为对利益相关方的额外通知，这些可能会是通则本身的变更，影响到特殊各论章节的通过性检测。”
Following your registration on the Pharmacopeial Forum website you get access to the complete drafts of general chapters <660> and <1660>.
在药典论坛官网注册后，你就能找到通则<660>和<1660>。
来源：Julia法规翻译
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