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Comparison of nitrogen supply modes in pharmaceutical industry

2021-08-09 H:57:19

At present, there are three nitrogen supply modes in pharmaceutical production: cylinder nitrogen supply, liquid nitrogen gasification supply and pharmaceutical nitrogen generator nitrogen supply. A. The nitrogen purity of steel cylinder is low, generally only 99.5% ~ 99.9%, and contains harmful impurities such as microorganisms and pyrogen, which can not be guaranteed to meet the GMP verification requirements. The so-called sterile products are required to be dust-free, microbial free and pyrogen free, which is difficult to guarantee the nitrogen supply of steel cylinders. The cost of bottle nitrogen is the highest. For occasions with large consumption, more labor, quantity reserve and floor space are required, and the use and operation are also very inconvenient.

B. The purity of liquid ammonia can meet the process requirements. However, in the preparation process, the pipeline device and replacement storage tank are difficult to meet the confirmation of cleaning and disinfection, and there are defects in nitrogen that cannot be verified by microorganisms, heat sources and other items. At the same time, or during transportation, due to the pollution of uncertain factors such as equipment, materials and accessories, the purity is easy to be reduced. Therefore, it is difficult to ensure that the final purity and dust content of liquid nitrogen meet the requirements of GMP verification.

C. High purity medicinal nitrogen generator includes three systems: air compressor and compressed air purification system, polystyrene ammonia generator system and nitrogen dust removal, deodorization and sterilization purification system. The nitrogen generator body is made of all stainless steel, advanced and perfect nitrogen generator technology and unique and simple structural design. The nitrogen purification filter group includes high-efficiency dust removal filter, high-efficiency deodorization filter and high-efficiency sterilization filter. After treatment, the product nitrogen can be dry (dew point ≤ - 45 ℃), oil-free (oil content ≤ 0.001pm), filtration accuracy 01um, odorless and sterile, 100% filtered bacteria and bacteriophages, which can meet the requirements of GMP production of sterile preparations.

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