药用氮气的标准

Nitrogen Use in pharmaceutical Production

药品生产使用的氮气

Nitrogen often comes in contact with a product during manufacturing and is therefore relevant for its quality, especially when it comes to the manufacture of sterile products. Nonetheless, the use of nitrogen is significantly less specified than that of pharmaceutical water. Parameters and limits have to be defined by the pharmaceutical users themselves.

在生产过程中氮气往往与产品接触，因此它是质量相关的，特别是当它用于无菌药品生产时。尽管如此，相比于制药用水，氮气的使用却很少规范。

Like with pharmaceutical water, the first sources of information are pharmacopoeias. The European Pharmacopoeia defines two types of nitrogen: “medical nitrogen” and “nitrogen with low oxygen content”. As the name suggests, the first is used for medical purposes, e.g. in hospitals. The latter can be used for the inertisation of oxygen-sensitive pharmaceuticals, for example. There are no parameters for water content, oil or particles, however. It seems inadequate that the only specification is 99.5% purity for nitrogen with low oxygen content. The remaining 0.5% could, depending on manufacture, storage and distribution, very well consist of water, oil, etc.

This nitrogen quality is also interesting when it comes to the use of nitrogen generators (molecular sieve technique), though. Those can be a suitable alternative for the well-known compressed-gas bottles in many use cases.

当使用氮气发生器（分子筛技术）时，它的氮气质量引人关注。在很多使用情况下，它们也可以作为众所周知的压缩气体瓶的一个合适的替代。

As is the case with compressed air (see a lsoRequirements for compressed Air in the Pharmaceutical Industry), the pharmaceutical user has to define their own specifications depending on application and product risk. The 2010 ISO 8573-1 can be useful here. A specification according to class 2 is helpful in most cases – this excludes particles > 5 μm. Microbiological limits can be defined in accord with the class of purity in which the nitrogen is being applied.

与压缩空气（见制药行业压缩空气要求）一样，药品厂商需要根据使用和产品风险定义他们自己的标准。这里，2010版ISO8573-1应该有用。根据它的2级标准在大多数情况下是有用的——排除了>5μm微粒。微生物限度可以定义与氮气被使用的纯度级别相一致。

In conclusion, nitrogen may be seen as an excipient, even though the amount of it remaining in a finished product is insignificant compared to classic excipients like lactose. Therefore, the EG Guideline 2015/C 95/02 can be consulted for risk assessment concerning contamination or for qualification requirements

总之，氮气可以被视为辅料，尽管相比典型的辅料，如乳糖，它在成品中的数量没那么重要。因此，EG指南2015/C 95/02 可以被作为关于污染的风险评估或确认需求的参考。

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