Home > Industry Information > Strengthen the molecular sieve oxygen regulation for the benefit of people's health
Strengthen the molecular sieve oxygen regulation for the benefit of people's health
2021-06-20
Oxygen is a key substance in the body's metabolic activity and it is the first need for human life. The timely supply of oxygen can improve the body's physiology, biochemical environment, and promote the benign cycle of metabolic processes, so as to achieve the purpose of treating diseases, alleviating symptoms, promoting health and preventing diseases, and enhancing physical fitness. Therefore, oxygen plays an extremely important role in the medical field, especially emergency treatment for critically ill patients and accidental injuries. Oxygen delivery has long been one of the prerequisites for various medical institutions.
Medical oxygen refers to the oxygen used for salvage and assistive treatment of patients. In China, medicinal oxygen was included in pharmaceuticals for management since 2000. The mandatory national standards for medical oxygen are stipulated in the “2005 Pharmacopoeia of the People's Republic of China”. The concentration of medical oxygen is not less than 99.5%. At the same time, harmful gases and impurities such as carbon monoxide and carbon dioxide must be filtered during the production process, and oxygen oxygen must be attached to the oxygen cylinder. Medical oxygen and industrial oxygen should be filled separately. There should be a special filling line and a special bottle library. The entire production process should be inspected and certified by the health department.
With the development of science and technology, molecular sieve oxygen equipment technology has matured, and the scope of medical oxygen coverage has also expanded to the field of molecular sieve oxygen production. Currently, there are two kinds of techniques for making medical oxygen in the world:
One is a cryogenic air separation method, and the other is a molecular sieve oxygen generator for medical use. Oxygen obtained by cryogenic air separation method According to drug management, the 1953 Pharmacopoeia contained the standard for oxygen generation by cryogenic air separation. Its standard oxygen content must be greater than 99.5%. For such production enterprises, the oxygen production enterprises of the cryogenic air separation method must implement drug production license management and be certified by the pharmaceutical production quality management standard. This is a method of oxygen production.
Another kind of medical molecular sieve oxygen, using pressure swing adsorption to extract high concentrations of medical oxygen from the air. At the time of 1998, the State Administration of Pharmaceuticals formulated and issued the "General Technical Specifications for Medical Molecular Sieve Oxygen Making Devices." This technical standard is also partly cited by international standards. The concentration of oxygen in the gas of this product is greater than 90%, collectively referred to as 93% of oxygen. The molecular sieve oxygen-making equipment is managed by the second-class Medical Equipment, and is approved and registered by the provincial food and drug supervision department. For example, in the United States, the FDA also administers medical molecular sieves as medical devices. The products are mainly used for the adjuvant treatment of patients in urgent need of oxygen and the treatment of military oxygen.
Recently, the medical oxygen problem has become the focus of the public. In some areas, industrial oxygen is used instead of medical oxygen, and the concentration of gas produced by large-scale molecular sieve oxygen equipment used in some hospitals is lower than 90%. Some scholars have proposed the use of medical oxygen. Questionable opinion.
In response to this situation, the State Food and Drug Administration attaches great importance to the safety of oxygen of 93%, and repeatedly cooperates with medical institutions, medical device inspection agencies, medical oxygen production companies, and experts to demonstrate 93% of medical oxygen. Based on the demonstration, in 2008 the China Medical Device Industry Association also conducted surveys on 158 large and medium-sized medical institutions. Among them, approximately 40% of medical institutions including some very large medical institutions use molecular sieve oxygen generators. As a result of the survey, the overall operation of the equipment is good. Check the database of adverse events of medical equipment of the National Center for Adverse Drug Reaction Monitoring. From 2003 to 2009, there were no reports of 93% oxygen-related suspicious medical device adverse events.
Medical device management and clinical experts believe that clinically used oxygen generally uses lower concentrations of oxygen (less than 50%), only anesthesia, ICU ward (intensive care unit) may have different uses and oxygen concentration, so 93% Oxygen can fully meet the clinical needs. The 93% technical process for medical molecular sieve oxygenation is mature. As long as the operation is standard, 93% oxygen safety is also guaranteed to meet clinical needs. Judging from the expert panel discussion, reports of adverse reactions, and safety evaluation analysis, it is still not possible to conclude that 93% of oxygen is insecure, so its safety is guaranteed.
93% of oxygen has the advantages of being convenient, cheap, and widely used in general clinical applications, and it can be said to be a technological innovation for the benefit of mankind. It is understood that the State Food and Drug Administration will strengthen management, and 93% of oxygen is currently being included in the new edition of the Pharmacopoeia. We believe that as long as management is strengthened to prevent industrial oxygen from entering the clinical use environment, molecular sieve oxygen production equipment is a good tool for helping the country and the people, reducing medical expenses, and good equipment.
Medical oxygen refers to the oxygen used for salvage and assistive treatment of patients. In China, medicinal oxygen was included in pharmaceuticals for management since 2000. The mandatory national standards for medical oxygen are stipulated in the “2005 Pharmacopoeia of the People's Republic of China”. The concentration of medical oxygen is not less than 99.5%. At the same time, harmful gases and impurities such as carbon monoxide and carbon dioxide must be filtered during the production process, and oxygen oxygen must be attached to the oxygen cylinder. Medical oxygen and industrial oxygen should be filled separately. There should be a special filling line and a special bottle library. The entire production process should be inspected and certified by the health department.
With the development of science and technology, molecular sieve oxygen equipment technology has matured, and the scope of medical oxygen coverage has also expanded to the field of molecular sieve oxygen production. Currently, there are two kinds of techniques for making medical oxygen in the world:
One is a cryogenic air separation method, and the other is a molecular sieve oxygen generator for medical use. Oxygen obtained by cryogenic air separation method According to drug management, the 1953 Pharmacopoeia contained the standard for oxygen generation by cryogenic air separation. Its standard oxygen content must be greater than 99.5%. For such production enterprises, the oxygen production enterprises of the cryogenic air separation method must implement drug production license management and be certified by the pharmaceutical production quality management standard. This is a method of oxygen production.
Another kind of medical molecular sieve oxygen, using pressure swing adsorption to extract high concentrations of medical oxygen from the air. At the time of 1998, the State Administration of Pharmaceuticals formulated and issued the "General Technical Specifications for Medical Molecular Sieve Oxygen Making Devices." This technical standard is also partly cited by international standards. The concentration of oxygen in the gas of this product is greater than 90%, collectively referred to as 93% of oxygen. The molecular sieve oxygen-making equipment is managed by the second-class Medical Equipment, and is approved and registered by the provincial food and drug supervision department. For example, in the United States, the FDA also administers medical molecular sieves as medical devices. The products are mainly used for the adjuvant treatment of patients in urgent need of oxygen and the treatment of military oxygen.
Recently, the medical oxygen problem has become the focus of the public. In some areas, industrial oxygen is used instead of medical oxygen, and the concentration of gas produced by large-scale molecular sieve oxygen equipment used in some hospitals is lower than 90%. Some scholars have proposed the use of medical oxygen. Questionable opinion.
In response to this situation, the State Food and Drug Administration attaches great importance to the safety of oxygen of 93%, and repeatedly cooperates with medical institutions, medical device inspection agencies, medical oxygen production companies, and experts to demonstrate 93% of medical oxygen. Based on the demonstration, in 2008 the China Medical Device Industry Association also conducted surveys on 158 large and medium-sized medical institutions. Among them, approximately 40% of medical institutions including some very large medical institutions use molecular sieve oxygen generators. As a result of the survey, the overall operation of the equipment is good. Check the database of adverse events of medical equipment of the National Center for Adverse Drug Reaction Monitoring. From 2003 to 2009, there were no reports of 93% oxygen-related suspicious medical device adverse events.
Medical device management and clinical experts believe that clinically used oxygen generally uses lower concentrations of oxygen (less than 50%), only anesthesia, ICU ward (intensive care unit) may have different uses and oxygen concentration, so 93% Oxygen can fully meet the clinical needs. The 93% technical process for medical molecular sieve oxygenation is mature. As long as the operation is standard, 93% oxygen safety is also guaranteed to meet clinical needs. Judging from the expert panel discussion, reports of adverse reactions, and safety evaluation analysis, it is still not possible to conclude that 93% of oxygen is insecure, so its safety is guaranteed.
93% of oxygen has the advantages of being convenient, cheap, and widely used in general clinical applications, and it can be said to be a technological innovation for the benefit of mankind. It is understood that the State Food and Drug Administration will strengthen management, and 93% of oxygen is currently being included in the new edition of the Pharmacopoeia. We believe that as long as management is strengthened to prevent industrial oxygen from entering the clinical use environment, molecular sieve oxygen production equipment is a good tool for helping the country and the people, reducing medical expenses, and good equipment.
93% Purity Medical Oxygen Generator is the oxygen generator manufactured for hospitals, clinics,etc.These places were normally supplied with cylinder oxygen. But for some area, cylinder oxygen is expensive and difficult to transport. This 93% purity medical oxygen generator is able to fill cylinders at site. Some customer use the 93% purity oxygen directly to hospital centralized oxygen supply system. The whole product has air compressor, air treatment part, air tank, oxygen separator and oxygen buffer tank. It is easy to install, easy to operate, fast to produce quolified oxygen.
93% Purity Medical Oxygen Generator, Medical Oxygen Generators For Hospital, Purity 93% Psa Medical Oxygen Generator
Sofine Electric Co., Ltd. http://www.gammagases.com