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Ph. Eur. Draft on Depyrogenation ofPackaging Materials

欧洲药典：包装材料去热原法草案

A draft of anew Ph. Eur. general chapter 5.1.12. Depyrogenation of items used inthe production of parenteral preparations has been published inPharmeuropa - Issue 30.4. The draft is open for comments until December 31,2018.

欧洲药典通则5.1.12新增草案注射剂药品生产中去热源项目，其于药典通知30.4中发布。草案在2018年12月31日前开放供评论。

The new generalchapter covers pyrogen inactivation or removal from materials such asprimary packaging systems and equipment coming into direct contact withproducts finally sterilized. Pyrogens in general are substances that have theability to induce fever when infused or injected. The draft chapterdefines depyrogenation "in terms of a reduction inlipopolysaccharide, the most potent and difficult-to-eliminate of pyrogenicmaterials".

该新章节包含热原灭活或者从物料中移除，例如与最终灭菌产品直接接触的内包装系统和设备。热原一般是在注入或注射时有能力诱发发热的物质。该草案定义的“去热原法”为从降低脂多糖的角度，最有效和最难消除的致热材料。

According tothe chapter depyrogenation can be carried out by dry heat treatment (for glassand other non-heat-labile materials), and other treatments, like physical andchemical procedures. Those methods may be used when heat treatment is notpossible.

根据本章节，可使用干热处理的方法（针对玻璃和其他非热不稳定物料）及其他方法，例如物理和化学过程。通常“热法”不适用时，会使用物理和化学过程。

Validation验证

All processes mustbe validated by adding suitable endotoxin indicators (i.e. lipopolysaccharides)to the load in the positions identified as being the most difficult todepyrogenate. Depending on the material (e.g. glass, stainless steel,plastic) to be depyrogenated, a suitable endotoxin indicator is used duringvalidation. Ready-to-use endotoxin indicators are, forexample, ampoules, vials or other carriers that have been inoculated with aknown amount of endotoxin. The material of the carrier must berepresentative of the item that is being depyrogenated. Custom-made endotoxinindicators are primary packaging materials or equipment that have beensurface-inoculated with a suitable endotoxin reference standard.The endotoxin recovery rate is determinedon materials that have not been depyrogenated in order tocalculate the percentage recovery and to check any interference with leachables.The criterion for process validation is set as a 3.0log10 reduction in recoverable endotoxin.

所有的过程都必须经过验证，通过在最难去除热原的位置加入适当的内毒素指示剂（也就是内毒素）。根据待去热原的材料（例如：玻璃、不锈钢、塑料），在验证过程中使用适当的内毒素指示剂。现成的可以使用的内毒素指示剂包括：注入已知数量的安瓿瓶、小瓶或者其让他载体。载体的材质必须能够代表待去热原的材料的材质（译者注：材质具有代表性）。定制的内毒素指示剂是内包材或者设备，这些设备表面使用适当的内毒素参考标准灌输。为计算百分比回收率，并检查浸出物是否产生干扰，内毒素回收率要采用未去热原的物料测定。工艺验证标准设定为可回收内毒素降低3.0log10。

Moreinformation can be found following your registration on the Pharmeuropawebsite.

在 Pharmeuropawebsite上注册后, 可以找到更多信息。

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