Pharmaceutical nitrogen generator – Medical high-purity nitrogen generator technology
The PSA nitrogen generator (also known as PSA nitrogen production equipment or PSA nitrogen production unit) is a device that uses compressed air as the raw material and employs a type of adsorbent called carbon molecular sieve to selectively adsorb nitrogen and oxygen from the air, thereby separating the nitrogen from the air. Depending on the classification method, namely deep cooling air separation method, molecular sieve air separation method (PSA), and membrane air separation method, the nitrogen generators used in industry can be divided into three types.
From a technical perspective, the nitrogen generator is a nitrogen equipment designed and manufactured based on the PSA technology. The nitrogen generator uses imported carbon molecular sieves (CMS) as the adsorbent and adopts the principle of pressure swing adsorption (PSA) at room temperature to separate air and produce high-purity nitrogen. Usually， two adsorption towers are connected in parallel， and the imported PLC controls the inlet pneumatic valves to operate automatically， alternating between pressurized adsorption and depressurized regeneration to complete the nitrogen-oxygen separation and obtain the required high-purity nitrogen.
From the working process perspective， the nitrogen generator compresses air through a compressor， then enters a cold dryer for cryogenic drying to meet the dew point requirements of the PSA nitrogen generation system for the raw air. After passing through a filter to remove oil and water from the raw air， it enters an air buffer tank to reduce pressure fluctuations. Then, the pressure is adjusted to the rated working pressure by a pressure regulating valve and sent to two adsorption tanks (containing carbon molecular sieves). Here, the air is separated and nitrogen is produced. The raw air enters one of the adsorption tanks and produces nitrogen； the other adsorption tank undergoes depressurization, desorption, and regeneration. The two adsorption tanks work alternately, continuously supplying raw air and continuously producing nitrogen. The nitrogen is sent to a nitrogen buffer tank, where the pressure is adjusted to the rated pressure by a pressure regulating valve； then, it is measured by a flow meter and analyzed and detected by a nitrogen analyzer. Qualified nitrogen is reserved, and unqualified nitrogen is vented (when the nitrogen generator is just turned on).
The nitrogen generator is characterized by its convenient and rapid production of nitrogen gas. Due to its advanced technology and unique air flow distributor, the air flow is distributed more evenly. By using carbon molecular sieves, qualified nitrogen gas can be provided within 20 minutes. It is easy to use and the equipment has a compact structure, is integrated and installed as a unit, occupies a small area and does not require infrastructure investment. The investment is low and on-site, only the connection to the power supply is needed to produce nitrogen gas. Compared with other nitrogen supply methods, it is more economical. Because the PSA process is a simple nitrogen production method, using air as the raw material, the energy consumption is only the electricity consumed by the air compressor, it has the advantages of low operating cost, low energy consumption and high efficiency. With the advancement of automation technology, the nitrogen generator is designed based on the integration of mechanical and electrical systems to achieve automatic operation. That is, imported PLC controls the fully automatic operation. The nitrogen gas flow, pressure and purity can be adjusted and continuously displayed, and it can achieve unmanned operation.
In the pharmaceutical industry, the requirements for medical-grade nitrogen are very high, with high purity. The difference between the medical-grade nitrogen generator and other nitrogen equipment is that due to the international standard GMP requirements in the pharmaceutical industry, the parts in contact with drugs or drug solutions all use stainless steel materials and have requirements for sterilization. The equipment needs to be made of stainless steel, and a sterilization filter device is installed at the nitrogen gas outlet of the equipment. Also, due to the high overall requirements for equipment by pharmaceutical factories, they usually have configurations. It is understood that with the improvement of GMP standards, many pharmaceutical machinery factories have also made efforts in this aspect, and there are many standard-compliant medical-grade high-purity nitrogen generators on the market. Medical-grade high-purity nitrogen generators are suitable for food, pharmaceutical industries, water injection, powder injection, large-volume infusion drugs, as well as biochemical and isolation transportation nitrogen supply equipment. They are mainly composed of a compressed air post-treatment system, a PSA pressure adsorption system and a gas precision filtration and sterilization system.
Industry insiders explain that the medicinal high-purity nitrogen generator adopts the latest international PSA nitrogen production process, with fully polished stainless steel and a unique adsorption device design, ensuring the production of high-purity nitrogen (higher than international oxygen-free requirements), which can reach over 99.99% purity. It is free of heat sources and bacteria, meeting the GMP production requirements of the international pharmaceutical industry. At the same time, it uses an automatic control and monitoring system, enabling the equipment to operate automatically and allowing for unmanned operation. It is widely used in the pharmaceutical industry.
Only equipment that meets standards can ensure the safety of pharmaceutical production. Nitrogen generator equipment enterprises should abide by honest business practices, make more efforts in improving equipment performance and technology, and better serve the pharmaceutical industry.
