Nitrogen is widely used in the manufacturing process to prevent oxidation in the pharmaceutical industry. It is mainly used in pharmaceutical packaging, medical ventilation and pharmaceutical transportation atmosphere. Nitrogen is also used as an effective means of protection during the storage of some easily oxidized reagents. Nitrogen is widely used in the manufacturing process to prevent oxidation in the pharmaceutical industry. It is mainly used in pharmaceutical packaging, medical ventilation and pharmaceutical transportation atmosphere. Nitrogen is also used as an effective means of protection during the storage of some easily oxidized reagents.
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) have high requirements for nitrogen With the implementation of the new version of GMP and the gradual integration with the international pharmaceutical industry, the scope of nitrogen used in the pharmaceutical industry is becoming wider and wider, and the quality requirements for nitrogen are becoming higher and higher From the perspective of GLP verification, the three nitrogen supply schemes of steel cylinder nitrogen supply, liquid nitrogen gasification nitrogen supply and pharmaceutical high-purity nitrogen generator are compared, and the rationality and verification of the application of pharmaceutical nitrogen generator in the production process of medicine and food are analyzed from the aspects of rationality, reliability and economy.
According to the principle of pressure swing adsorption, high-quality carbon molecular sieve is used as adsorbent to produce nitrogen from air under certain pressure. The purified and dried compressed air is adsorbed under pressure and desorbed under reduced pressure in the adsorber. Due to the aerodynamic effect, the diffusion rate of oxygen in the micropores of carbon molecular sieve is much higher than that of nitrogen. Oxygen is preferentially adsorbed by carbon molecular sieve, and nitrogen is enriched in the gas phase to form finished nitrogen. After that, the adsorbent will desorb the adsorbed oxygen and other impurities to realize regeneration. Generally, two adsorption towers are set in the system. One tower adsorbs nitrogen and the other tower desorbs and regenerates. The PLC program controller controls the opening and closing of the pneumatic valve to make the two towers cycle alternately, so as to achieve the purpose of continuous production of high-quality nitrogen.
The pharmaceutical nitrogen generator is mainly used in pharmaceutical packaging, medical ventilation, medical transportation atmosphere, etc. in the pharmaceutical industry.
With the implementation of the new version of 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 expanding, and the quality requirements for nitrogen are becoming higher and higher. In the pharmaceutical industry, nitrogen, as a protective gas source, is not an ordinary gas source in a simple sense. As an important link in the production of the pharmaceutical industry, its impact on the quality of drugs 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) and other requirements for nitrogen are as follows:
① The purity of atmosphere ≥ 99.999%, i.e. the oxygen free requirement in the national standard;
② Nitrogen does not contain dust particles and pyrogen, 1cfu/m of microorganisms ³ (it can be used for filling and sealing of injections);
③ Nitrogen can maintain constant pressure supply during production to ensure normal operation of production.