20140709 ECA新闻：有没有什么生产设备是官方批准的？

20140709 ECA新闻：有没有什么生产设备是官方批准的？ by julia翻译2014-07-29 蒲公英

原文网址：http://www.gmp-compliance.org/en ... n-equipment%3F.html

GMP News
09/07/2014

Is there something like Authorities' approved production equipment?

有没有什么生产设备是官方批准的？

Quite often the question comes up whether this or that piece of equipment is approved by authorities, or whether there are lists with approved equipment. The question can be answered with a clear 'No'. There are approvals for pharmaceutical products only, not for production equipment. Authorities or GMP guidelines neither allow equipment, nor do they forbid their usage (with the exception of filters emitting fibers). Here, companies have the freedom of choice but also the responsibility to use the equipment appropriate for their process or product. Standard equipment can be modified to fit best on the own process.

经常会有人问是不是有哪个设备是经过官方批准的，或是否有一个经过批准的设备清单，回答当然是很清楚的：没有。只有药品才是会被批准的，生产设备是没有的。药监局或GMP指南不会允许也不会禁止使用一个设备（除了掉落纤维的过滤器外）。在这方面，公司有自己的自由进行选择，但也有责任保证所用的设备适用于其工艺或产品，也可对标准设备改造后使其适用于自己的工艺。

GMP guidelines require that the selected equipment is suitable for the application and which can be sufficiently cleaned and maintained. Surfaces that have contact with in-process material or product are supposed to be non-reactive, additive, or absorptive to prevent that the quality decreases beneath the defined requirement.

GMP指南要求所选择的设备适用于其用途，可以进行充分地清洁和维护。与在制物料或成品直接接触的表面应不会发生反应、不会对产品有吸附或添加，不会使得质量降低至既定的要求以下。

With regard to lubricants and synthetic/sealing materials this is different. The US FDA does not admit any seals, but has a white list of substances in their guidelines text they consider harmless. However, this merely means that these substances are not toxic in small quantities and therefore may be used. It does not imply their suitability for the own process or the proof of compatibility. For instance, EPDM is listed as sealant in 21 CFR 177.2600, but is not resistant in contact with oils or fats and may not be used in these cases.

关于润滑剂和合成/密封材料，则有不同要求。美国FDA不认可任何密封，但在其指南中有一个被认为是无害的物质的清单。当然，这只是表示这些物质在小量时无毒，因此可以使用，并不是说它们对于你的工艺来说是安全的，或其相容性是完全有保障的。例如，EPDM被列在21 CFR 177.2600中作为密封材料，但不能与油脂接触，因此如果有油脂时则不能使用。

With regard to lubricants there is also a Positive list in the CFR, to which the components of a lubricant must be traceable. Alternatively, lubricants can be listed by the NSF in the so-called White Book. To do this, the NSF offers a registration procedure, which shows the toxicological safety.

关于润滑剂，在CFR中还有一份认可清单，根据该要求，润滑剂的组份是要可以追踪的。另外，NSF也可将润滑剂列在所谓白皮书上。NSF有一个注册程序，在其中指明了列入白皮书的毒性安全性要求。

In addition there are organisations that may be of benefit for the selection of equipment or equipment parts. For example, the EHEDG checks and certifies the cleanability of equipment. The Fraunhofer IPA rates materials with respect to their cleanroom suitability. Here, cleanability, organic resistance, abrasion / particle emission and outgassing are examined.

另外，还有一些组织可能有助于对设备或设备部件的选择。例如，EHEDG检查和认证设备的可清洁程度，FRAUNHOFER IPA对洁净室安全性使用材料分级。他们会对可清洁程度、有机阻断、磨损/颗粒发散和散出气体进行检测。

好像是中国制药装备行业协会主管吧

好资料，谢谢楼主分享

感谢楼主分享，学习了