是否允许在GMP区域使用镀镍的部件？

Are Nickel-Plated Components Allowed inthe GMP Area?

是否允许在GMP区域使用镀镍的部件？

The nickel platingof surfaces is a good and high-quality method to protect components or surfacesfrom corrosion. At the same time, the question is repeatedly asked whethercomponents treated in this way may be used in the GMP area.

表面镀镍是保护零部件或表面免受腐蚀的一种良好而高质量的方法。与此同时，也有人反复提出的问题，以这种方式处理的部件是否可以用于GMP领域。

In most cases,nickel-plated parts cannot be visually distinguished from stainless steel. Inpractice, this indistinguishability actually leads to a risk of confusion,which is why such parts are often banned in GMP operations, e.g. for screws and similar small parts. 

在大多数情况下，外观上无法将镀镍零件与不锈钢区分开来。实际上，这种不可区分性导致了混淆的风险，这就是为什么在GMP操作中经常禁止这些部件，例如螺丝和类似的小部件。

Indeed, this indistinguishability leads to a risk of confusion in practice -especially for small unmarked material. Basically, a strict separation ofblack and stainless steel must be observed in stainless steelprocessing. For this reason, nickel-plated screws and similar small parts areforbidden in the GMP stainless steel workshop or on such a construction site.Alternatively, one takes care to ensure a strict separation of areas, magazinesand tools. The reason: nickel-plated parts are susceptible to electrochemicalcontact corrosion, especially when the surface is damaged and in a moistenvironment.

实际上，这种不可区分性导致了实践中的混淆风险-特别是对于小的无标签材料。基本上，在不锈钢加工过程中必须严格区分黑钢和不锈钢。由于这个原因，镀镍螺丝和类似的小零件在GMP不锈钢车间或类似现场是禁止的。或者，你要注意确保区域，杂志和工具的严格分离。原因：镀镍零件容易受到电化学接触腐蚀，特别是当表面受损和在潮湿的环境中。

In the productcontact zone, nickel-plated parts are typically not GMP-compliant, becausethese zones are cleaned with purified water (PW) [conductivity less than1.1µS/cm at 20°C] during the cleaning process of the final rinse. When inregular contact with such ultrapure water, nickel-plated parts are usually notcorrosion-resistant.

在产品接触区域，镀镍部件通常不符合GMP，因为这些区域在最后冲洗的清洗过程中用纯净水(PW)[导电率小于1.1μs/cm，20℃]清洗。当经常与这种超纯水接触时，镀镍零件通常不耐腐蚀。

In the GMPenvironment, however, surfaces that do not come into contact with the productare often treated with cleaning and disinfecting agents (e.g. clean room wallsof class D+C+B+A or the surfaces of machines located in rooms of the clean roomclasses mentioned). Here, too, ultrapure water as well as various chemicals areused (e.g. ammonium compounds), which can attack nickel-plated surfaces.

然而，在GMP环境中，不与产品接触的表面通常会用清洁剂和消毒剂进行处理(例如d+c+b+a级的洁净室墙壁或上述洁净室的机器表面)。这里也使用了超纯净水以及各种化学物质(例如铵化合物)，它们可以攻击镀镍表面。

However, the useof nickel-plated components is not generally prohibited by GMP. There isno official requirement or concrete written regulations. But: Not to usenickel-plated components in the above-mentioned areas is in accordance with thestate of the art in science and technology. And adherence to the state ofscience and technology is a GMP requirement.

然而，GMP并不禁止使用镀镍元件。没有正式的要求或具体的书面规定。但是：在上述领域不使用镀镍元件是有科学依据的。坚持科学和技术的是GMP的要求。

The situation isdifferent when using nickel-plated parts in the field of drives, electricalscrew connections or e.g. pneumatic connectors. This is possible in GMPoperation and the use is harmless if these parts are separated from the area incontact with the product and from the clean room (preferably by separating themachine room from the process room, if necessary by encapsulating the area).
The use is also possible for GMP clean rooms below class D - depending on theproduct and the specific cleaning or disinfection procedure.

在驱动器、电子螺丝连接器或气动连接器等领域使用镀镍零件时，情况就不同了。这在GMP操作中是可能的，如果这些部件与与产品接触的区域和洁净室分开(最好是通过将机房与处理间分开，如有必要，封闭该区域)，则使用是无害的。根据产品和具体的清洁或消毒程序，D级以下的GMP洁净室也可能可以使用。