翻译：
JULIA 来源：Julia法规翻译
26.06.2017
Visual Inspection Boardfinishes work on Container-/Closure-Integrity Document
目视检查委员会已完成其容器
/
密闭器完整性文件
Members of the ECA Visual Inspection Board havefinished their work on a position paper regarding
Container-/Closure-Integritytesting
. The new document discusses leak testing of sterile containers andhas been released as the uncertainty in the pharmaceutical industry increases,how integrity testing has to be handled in the near future. There is already anumber of companies preparing for a 100 % integrity testing, which is already amust for ampoules. But the testing of 100% of a batch does not give a 100%security. It is much more important that the concept of testing is adequate.For example a 100% testing does not answer the question, what tight is, or howtight a container should be. Another question should also be answered, before atesting is done: What kind of leaks or cracks should be detected. And how doartificial leaks correlate with the risk of microbial contamination? As the100% testing method must be validated, it should also be clear how artificialwholes or cracks can be made in a reproducible way.
ECA
目视检查委员会成员已完成其关于容器
/
密闭器完整性测试立场文件。新的文件讨论了无菌容器的泄漏测试，由于药业不确定性增加因此已经发布，其中还讨论了不久的未来要如何处理完整性测试。已有大量公司准备进行
100%
的完整性测试，对于安瓿瓶来说这本来也是必须的。而对一批产品进行
100%
测试并不能保证
100%
安全。充分测试更为重要。例如，
100%
测试并不能回答容器应该要多紧的问题。另一个要回答的问题是在测试之前，要检出什么样的泄漏和裂纹，人为泄漏与微生物污染风险之间的相互关系如何？由于
100%
测试方法必须进行验证，因此还需要清楚人工检查或裂纹要如何才能重复。
The new ECA paper complies with the requirements fromthe European Pharmacopeia and reflects
current industry practice
. Itwill be further developed to a guidance and it will also be harmonised it withthe US Pharmacopeia. Further, relevant changes possibly necessary due to thenew EU Annex 1, which is under revision at the moment, will also be addressed.The paper will be presented at the
upcoming event
of the ECA Visual InspectionGroup, 10-12 October 2017 in Vienna.
新的
ECA
文件汇总了欧洲药典的要求，反映了当前药业的做法。这份文件将会被制订成为指南，还会与美国药典融合。另外，目前仍在修订过程中的新
EU
附录
1
可能会引起的相关变更。文件将会在维也纳
