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Requirements for nitrogen in pharmaceutical industry

2021-08-09 H:58:46
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With the implementation of the new GMP, the rapid development of the pharmaceutical industry and the gradual integration with the international pharmaceutical industry, the scope of nitrogen used in the pharmaceutical industry is wider and wider, and the requirements for nitrogen quality are higher and higher. As a protective gas source, nitrogen is no longer an ordinary gas source in a simple sense. It is extremely important and its impact on drug quality can not be ignored. In the production of modern pharmaceutical industry, nitrogen protection in synthetic drugs, pure nitrogen isolation in bioengineering, nitrogen filling and sealing in the production of preparations (especially sterile preparations) require the following nitrogen:


① Nitrogen purity ≥ 99.999%, i.e. no oxygen requirement in national standard; ② Nitrogen contains no dust particles and pyrogen, microorganism < 1cfu (can be used for sealing of injection); ③ Nitrogen needs to maintain constant pressure supply in the production process to ensure the normal operation of production.

With the implementation of the new GMP, the rapid development of the pharmaceutical industry and the gradual integration with the international pharmaceutical industry, the scope of nitrogen used in the pharmaceutical industry is wider and wider, and the requirements for nitrogen quality are higher and higher. As a protective gas source, nitrogen is no longer an ordinary gas source in a simple sense. It is extremely important and its impact on drug quality can not be ignored. In the production of modern pharmaceutical industry, nitrogen protection in synthetic drugs, pure nitrogen isolation in bioengineering, nitrogen filling and sealing in the production of preparations (especially sterile preparations) require the following nitrogen:  ① Nitrogen purity ≥ 99.999%, i.e. no oxygen requirement in national standard; ② Nitrogen contains no dust particles and pyrogen, microorganism < 1cfu (can be used for sealing of injection); ③ Nitrogen needs to maintain constant pressure supply in the production process to ensure the normal operation of production.

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