GMP News
28/01/2015
Leakages in Ampoules cause Recalls
安瓿泄漏引发召回
Again, there is a recall of sterile ampoules in Switzerland. The manufacturer stated a possible leakage as reason for the recall. The area concerned seems to be the breaking point as was the case in the recall by Streuli Pharma in 2013. This case was presented at the ECA Conference "Particles in Parenterals and beyond" in Copenhagen in September 2014. Product had crystallized on the outer surface of the ampoule at the breaking point. Although the leakage could not be verified with any method available and no contamination of the product came to be known it was not possible to exclude that microorganisms could penetrate into the ampoule. Consequently, non-sterility could not be excluded. According to a statement from Streuli Pharma this packaging material problem could not be solved so that they had to change the primary packaging material within a very short time.
在瑞士又有一例无菌安瓿被召回。生产商宣布召回的原因是可能会有泄漏。泄漏点貌似是在安瓿折断点，与2013年Streuli Pharma的召回案例相同。该案例曾在ECA2014年9月哥本哈根“注射液中的颗粒及其它”讨论会中进行讨论。当时产品在安瓿瓶的折断点外表面结晶，尽管并没有方法来证明是由于泄漏引起结晶，也无法知道产品是否有受到污染，但不能排除微生物可能会渗入安瓿瓶。因此，无法排除染菌可能。根据Streuli Pharma公司的声明，该包材问题无法解决，因此他们不得不在很短时间内对内包材进行了变更。
You can find the case which occurred only now but is described in an analogous way at the page of Swissmedic. 你可以在瑞士药监官网上发现现在出现的召回案例以相似的方式已有描述。
Another sterile medicinal product had to be recalled in Switzerland because of crystallization of the product (particle formation) in the solution for injection. 在瑞士还有另一种无菌药品由于注射溶液中产品结晶（形成颗粒）需要召回。
Batches of another product were withdrawn from the market because of possible metal particles already in October. 另一个产品的批次由于可能有金属颗粒已于10月从市场撤回。