没看明白的缺陷项？

等待神的苦无

All，如题：

在NEXCHEM PHARMACEUTICALS CO LTD（浙江耐司康药业有限公司）2010年的缺陷项里，有提到如下内容：
a) There was inadequate separation of the product from personnel and product contacting surfaces after the terminal sterilization step.

所以？有谁明白具体意思么？sepration我懂，但和product contacting surfaces啥子关系？？？

longer881

我的理解是：终端灭菌后，产品的表面缺乏覆盖来防止人员的接触而导致的污染。

jixia

是不是这产品有什么特性啊，人员和产品接触表面有什么关系

chen5385973

标识很无奈 google了一下还是没懂

cnosema

产品终端灭菌之后，产品与（操作）人员以及产品接触表面的分离/隔离不够。

估计是产品终端灭菌之后，有再次被污染的风险吧。

等待神的苦无

cnosema 发表于 2016-11-14 22:57
产品终端灭菌之后，产品与（操作）人员以及产品接触表面的分离/隔离不够。

估计是产品终端灭菌之后，有 ...

产品与人员分隔不够我还懂，与产品接触表面分隔不够…，所以是灭完之后再拿棍儿杵杵？

夜风.

那这条缺陷怎么解决的

等待神的苦无

dingkaiwang 发表于 2016-11-14 19:51
是不是这产品有什么特性啊，人员和产品接触表面有什么关系

确实不明白，网上找不到相关信息。

等待神的苦无

夜风. 发表于 2016-11-15 09:47
那这条缺陷怎么解决的

那谁知道...，完全找不到相关的信息。
最可气的是，查了下，还发现貌似这个企业被收购了...
估计企业人员都换了一大波吧...

davidcone

欧盟网站上显示这个缺陷是说API的无菌保证的。看下面的原文，我的理解是产品与人员，以及产品与这个产品接触的表面，这几个方面的隔离不够。

davidcone

There was a lack of assurance of the sterility of the API in that: There was inadequate separation of the product from personnel and product contacting surfaces after the terminal sterilization step. There was inadequate protection of the sterile product due to a lack of localized laminar air flow during all tray loading, unloading, sieving, and blender unloading and sampling operations. There was inadequate protection of the sterile product as the final filtration vessel lacked an adequate seal. The loading, operation and unloading of the autoclave with equipment and final product containers was inadequately controlled by procedures and the validation of the autoclave cycles were inadequately validated. The transfer of equipment and items into the clean rooms via the transfer hatch was inadequately described in procedures, hence a consistent aseptic transfer could not be assured. The sterilizing in place of the filters, transfer lines and drying ovens could not be consistently assured as a result of inadequate labelling of valves and connections, unauthorised changes to validated temperature probes and a lack of a master temperature record against which to compare chart recorder traces. There was a lack of staff with adequate experience in sterile operations. There was a lack of assurance of integrity of the operations in the clean areas as there was no automatic changeover to the local generator in the event of a failure in the electricity supply.

以上是原文

davidcone

这个问题需要结合无菌API的生产过程来看，楼上各位大概是按照无菌制剂的角度来理解的。

等待神的苦无

davidcone 发表于 2016-11-15 14:12
这个问题需要结合无菌API的生产过程来看，楼上各位大概是按照无菌制剂的角度来理解的。

所以你的意思是“可能厂家API包装等（接触产品表面）不适当”，比如不能保证无菌，或者有破损风险之类？
我倒是没有往这个方向想，看来我还是太单纯了...，没想到这么夸张的....，

wildpant

不知道是什么产品，据我所知，nexchem主要是非无菌API。

davidcone

wildpant 发表于 2016-11-15 15:43
不知道是什么产品，据我所知，nexchem主要是非无菌API。

缺陷里说的是无菌原料药. 看不到具体的缺陷,无法判定

davidcone

等待神的苦无 发表于 2016-11-15 14:58
所以你的意思是“可能厂家API包装等（接触产品表面）不适当”，比如不能保证无菌，或者有破损风险之类？
...

要看具体缺陷.看这种描述,也许是包装,也许是容器.

cnosema

等待神的苦无 发表于 2016-11-15 14:58
所以你的意思是“可能厂家API包装等（接触产品表面）不适当”，比如不能保证无菌，或者有破损风险之类？
...

举例哈：

There was inadequate protection of the sterile product as the final filtration vessel lacked an adequate seal.过滤容器没有足够的密封。

再举例：

The loading, operation and unloading of the autoclave with equipment and final product containers was inadequately controlled by procedures and the validation of the autoclave cycles were inadequately validated.最终容器灭菌有问题。

还有：

The sterilizing in place of the filters, transfer lines and drying ovens could not be consistently assured as a result of inadequate labelling of valves and connections, unauthorised changes to validated temperature probes and a lack of a master temperature record against which to compare chart recorder traces.这些都是产品会接触到的表面