PSA nitrogen generators in the pharmaceutical industry

In the pharmaceutical industry, the production of aqueous injections (such as penicillin), large-volume parenteral solutions (such as amino acids), powder injections, lyophilized preparations, and oral liquid preparations all face the problem of product oxidation. How to extend the shelf life of the drug solution and ensure that there are no safety hazards for users has always been a concern for pharmaceutical manufacturers.

Nitrogen, as an inert gas with low activity, was quickly recognized for its wide range of applications in the pharmaceutical industry. High-purity nitrogen has proven effective in prolonging the oxidation process of synthetic drugs, isolating contaminants in bioengineering, and protecting traditional Chinese medicine from insects and decay.

Previously, most nitrogen used in pharmaceuticals came from industrial nitrogen in cylinders or liquid nitrogen vaporized into standard-state nitrogen. However, with the development of pharmaceutical machinery, high-purity nitrogen generators have emerged, providing greater convenience for pharmaceutical nitrogen use. These generators operate on the principle of molecular sieve pressure swing adsorption, using carbon molecular sieves as adsorbents to physically separate high-purity nitrogen from the air. The core process involves two adsorption towers: one for adsorption and nitrogen production, and the other for desorption and regeneration. These are automatically controlled by a program, with the two towers alternating in a cycle to achieve continuous production of high-quality nitrogen. This method of nitrogen acquisition has low infrastructure requirements, easy equipment maintenance, a high degree of automation, and low nitrogen costs, making it popular among many small and medium-sized nitrogen-using enterprises.

there are some differences between pharmaceutical nitrogen generators and ordinary nitrogen generators. The main difference is that pharmaceutical nitrogen generators need to meet international pharmaceutical industry standards, namely GMP certification. Parts that come into contact with drugs or liquid medicines are made of stainless steel and meet requirements for nitrogen dust removal, odor removal, and sterilization. The equipment and pipelines need to be made of stainless steel and undergo degreasing and purification treatment. Purification filtration and sterilization devices are installed at the nitrogen outlet of the equipment. Apart from these differences, the nitrogen production principle and production process are the same as those of ordinary nitrogen generators.