| 1. | Repair and maintenance operations should not affect the quality of the medicinal gases
任何维修和保养工作不能影响医用气体的质量。 |
| 2. | Water used for cooling during compression of air should be monitored for microbiological quality when in contact with the medicinal gas
空气压缩时使用的冷却水与医用气体接触时须监控该冷却水的微生物指标。 |
| 3. | The qualified person responsible for release of medicinal gases should have a thorough knowledge of the production and control of medicinal gases
一个合格的负责医用气体放行的人员必须通晓医用气体制造和控制的知识。 |
| 4. | Medicinal gases should be filled in a separate area from non - medicinal gases and there should be no exchange of containers between these areas
医用气体必须在与非医用气体隔断的区域灌装，并且所用的容器不能在这些区域间交换。 |
| 5. | A container is a cryogenic vessel , a tank , a tanker , a cylinder , a cylinder bundle or any other package that is in direct contact with the medicinal gas
容器是指低温容器，储罐、油罐车、气瓶、气瓶包或其他直接接触医用气体的包装物品。 |
| 6. | The medicinal gases filling manifold as well as the cylinders should be dedicated to a single medicinal gas or to a given mixture of medicinal gases ( see also 3 . 2 . 2 )
医用气体灌装分配器和气瓶应专用于一种医用气体或一种特定的混合气体。 |
| 7. | Manufacture of medicinal gases should comply with the basic requirements of gmp , with applicable annexes , pharmacopoeial standards and the following detailed guidelines
医用气体的工业制造必须按gmp的基本要求及相应的附件、药典标准和下述具体的原则。 |
| 8. | Definition of terms relating to manufacture of medicinal gases , which are not given in the glossary of the current pic / s guide to gmp , but which are used in this annex are given below
医用气体的制造相关条款的定义，它不是从当前的pic / s到gmp指南的所有术语，而是在下面列出本附件用到的术语。 |
| 9. | In the case of a single medicinal gas filled put into cylinders one at a time by individual filling operations , at least one cylinder of each uninterrupted filling cycle should be tested for identity and assay
在用单管一次给一个气瓶灌装一种医用气体的情况下，每个连续灌装周期中，至少有一瓶应做鉴别及分析。 |
| 10. | The manufacture of medicinal gases is generally carried out in closed equipment . consequently , environmental contamination of the product is minimal . however , there is a risk of cross - contamination with other gases
通常，医用气体的工业制造的过程是在密闭的设备中进行，因此，环境对产品的污染的可能性较小。但是，存在与其他气体的交叉污染的风险。 |
