Methods of production of medical gaseous oxygen
A method of producing medical oxygen gas clearly and unambiguously standardized. In  stated that the medical oxygen gas – is product obtained from the air by low-temperature distillation method.
Medical oxygen gas in cylinders can be produced by two technological schemes:
- Compression and gasification of liquid medical oxygen in the air separation unit and filling of cylinders;
- Compression and gasification of liquid medical oxygen in evaporators connected to storage tank unit and filling of cylinders.
Preferable from a security perspective is the production of medical oxygen gas using cryogenic gasifier for patients and medical staff in the absence of high-pressure oxygen and operations for filling it in cylinders. This method of production is economically beneficial because it allows you to significantly reduce transportation costs and excluding costs for the gasification and filling oxygen cylinders .
There are other physical and chemical methods of production of gaseous oxygen. But nowadays, the oxygen produced by these alternative methods may not be medical oxygen gas for two reasons:
- First, there are no approved by the Ministry of Health of Ukraine (MOZU) pharmacopoeial articles and other regulations governing the production of medical oxygen gas method other than the method of low-temperature fractionation of air DSTU GOST 5583:2009;
- Second, there is no registered in MOZU medicines “Medical oxygen gas” produced by methods different from the method specified in ISO 5583-78.
In Ukraine, currently some commercial medical institutions operate so-called oxygen concentrators of foreign production. This installation for gaseous oxygen pressure swing adsorption method with a maximum oxygen content of 95% oxygen by volume. Medical institutions that operate oxygen concentrators are actually also a drug manufacturers of “medical oxygen gas from the adsorption hub”. This raises two points.
The first of these is due to the fact that in accordance with the first paragraph of Article 9 of the Law “On medicines” for use in Ukraine they were admitted after their registration. Consequently, the drug “medical oxygen gas from the oxygen concentrator,” produced by medical institution shall be registered in the prescribed manner before the start of production and use. The second is caused by the fact that in accordance with the first paragraph of Article 10 of the Law of Ukraine production of medicines by persons or entities under license. According to this, the medical establishment, which involves exploiting oxygen concentrator must obtain a license to produce the drug – “Medical oxygen gas.”
At this point in the State Register of drugs appear only medical oxygen gas in cylinders with a capacity of 1 liter to 40 liters and medical oxygen gas produced from cryogenic gasifier.
World experience pharmacovigilance shows that some patients received many costly lessons from the use of drugs that have not been properly investigated and tested. The lack of stability in preparations made without compliance with GMP and under no control may adversely affect the health of patients.
1. DSTU GOST 5583:2009 “Oxygen gas technical and medical. Specification
2. VP Chizhichenko. Guide to the safe operation of oxygen tanks. – K.: Health and Safety, 2011. – 196s.
Tags: Press about us