EP检测-欧洲药典3.2.9

3.2.9.注射用粉针和冻干粉末容器胶塞标准

3.2.9. RUBBER CLOSURES FOR CONTAINERS FOR AQUEOUS

PARENTERAL PREPARATIONS, FOR POWDERS AND FOR

FREEZE-DRIED POWDERS

粉和冻干粉水肠外制剂胶塞材料通过高分子物质（弹性体）硫化（交联），

加入合适的添加剂获得。该规范也适用于粉和冻干粉在使用前立即被溶解在水中

的封闭容器。该规范不适用于硅橡胶制成的胶塞（在3.1.9处理，不封和油管的有

机硅弹性体），夹层封闭或漆封。弹性体由天然胶或合成物质的聚合，加聚或缩

聚产生。主要组成部分和各种添加剂的性质（例如硫化剂、促进剂、稳定剂、色素）取决于成品所需的属性。

Rubber closures for containers for aqueous parenteral preparations for powders and for freeze-dried powders are made of materials obtained by vulcanisation (cross-linking) of macromolecular organic substances (elastomers), with appropriate additives. The specification also applies to closures for containers for powders and freeze-dried products to be dissolved in water immediately before use.The specification does not apply to closures made from silicone elastomer (which are dealt with in 3.1.9. Silicone elastomer for closures and tubing), to laminated closures or to lacquered closures. The elastomers are produced from natural or synthetic substances by polymerisation, polyaddition or polycondensation. The nature of the principal components and of the various additives (for example vulcanisers, accelerators, stabilisers, pigments) depends on the properties required for the finished article.

胶塞材料可以分为两类：Ⅰ类胶塞符合严格要求，是首选；Ⅱ类胶塞有着适

用于特殊用途（如多孔冲孔）的机械性能，但因为它们的化学组成，不能满足第

一类那样的需求。

Rubber closures may be classified in 2 types : type I closures are those which meet the strictest requirements and which are to be preferred; type II closures are those which, having mechanical properties suitable for special uses (for example, multiple piercing), cannot meet requirements as severe as those

for the first category because of their chemical composition.

供特殊制备使用选择的胶塞如：

—与胶塞相关的制备部件不能吸附到胶塞的表面，不能迁移或通过胶塞的表面而影响制备。

—胶塞成批的不屈服的准备物质的数量足以影响其稳定性或目前的毒性风险。

The closures chosen for use with a particular preparation are such that :

—the components of the preparation in contact with the closure are not adsorbed onto the surface of the closure and do not migrate into or through the closure to an extent sufficient to affect the preparation adversely,

—the closure does not yield to the preparation substances in quantities sufficient to affect its stability or to present a risk of

toxicity.

胶塞与它们使用其整个有效期的准备兼容。该制剂的制造商必须从供应商获得保证，胶塞的组成不发生变化，这是相同的兼容性测试期间使用的封闭。当供应商通知制造商编制的构成变化时，兼容性实验必须重复，全部或部分，视变化的性质而定。

胶塞在使用前必须经过清洗和消毒。

The closures are compatible with the preparation for which they are used throughout its period of validity. The manufacturer of the preparation must obtain from the supplier an assurance that the composition of the closure does not vary and that it is identical to that of the closure used during compatibility testing. When the supplier informs the manufacturer of the preparation of changes in the composition, compatibility testing must be repeated, totally or partly, depending on the nature of the changes.

The closures are washed and may be sterilised before use.