经批准的生产设备是什么样？Is there something like Authorities' approved produ...

清歌一曲月如霜

很多时候，问题来了，这是否还是那件装备的批准机关，或是否有列表认可的设备。这个问题可以回答带有明显的“不”。有批文，药品，不适用于生产设备。当局或GMP指南既不让设备，也没有禁止其使用量（除过滤器发光纤维）。在这里，公司有选择的自由，但也使用该仪器适合自己的过程或产品的责任。标准设备可以被修改，以适应最好在自己的过程。
GMP指南要求所选择的设备是适合于该应用程序并能得到充分的清洁和维护。具有与在进程内的材料或产品接触的表面都应该是不反应的，添加剂，或吸收以防止其品质下面所定义的需求减少。
关于润滑油和合成/密封材料，这是不同的。美国FDA不承认任何封条，但在他们的指引文本的物质，他们认为无害的火红列表。然而，这仅仅意味着，这些物质是不少量有毒的，因而也可使用。这并不意味着他们是否适合自己的过程或兼容性的证明。例如，EPDM被列为密封剂在21 CFR 177.2600，但不抗与油或脂肪的接触，并且可以在这些情况下不能使用。
关于润滑剂也有一个肯定列表中的CFR中，向其中润滑剂的组分必须是可跟踪的。可选地，润滑剂可以在所谓的白书列出由NSF。要做到这一点，美国国家科学基金会提供的登记程序，足见其毒理学安全性。
此外，还有可能是有益的设备或设备部件的选择的组织。例如，EHEDG检查和认证设备的可清洁性。弗劳恩霍夫IPA费率的材料就其洁净室适用性。在这里，可清洁性，有机性，耐磨性/粒子发射放气进行检查。

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.
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.
With regard to lubricants and synthetic/sealing materials this is different. The US FDA does not admit any seals, but has awhite 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.
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.
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.

道路漫长黑暗

好吧楼主，翻译这部分好歹整理一下吗，太凌乱了

dtgyl

在线翻译的。