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The Difference Between Industrial Oxygen and Medical Oxygen

Before we get to the main topic, here is a set of statistics.

  • According to the national standard GB-T3863-2008, the oxygen content in industrial oxygen needs to be greater than or equal to 99.2% or greater than or equal to 99.5%.
  • According to the Chinese Pharmacopoeia, the oxygen content in medical oxygen is greater than or equal to 99.5%.

It may seem like there is only a hair's breadth of difference between medical oxygen and industrial oxygen, but is that really the case?

There is a drug called medical oxygen

Medical oxygen is used for clinical treatment and belongs to the category of pharmaceuticals, which has been included in GMP management since 2003. Like the conventional drugs we generally use, the State Food and Drug Administration has included the production of medical oxygen into the category of drug production management and given it a drug-approved name. In addition, medical oxygen as a drug has strict requirements for product traceability. Medical oxygen products need to be batch managed to trace the sales destination of each batch of products.

Medical oxygen manufacturers must obtain the following licenses to produce and sell medical oxygen: drug registration number, drug production license, GMP certificate; medical oxygen business enterprises must obtain a drug business license and GSP certificate to sell medical oxygen.

Hospitals, whether using oxygen cylinders or liquid oxygen, are also required to use oxygen that has been qualified for medical oxygen.

Industrial oxygen is a gas used for industrial production and product processing, used in chemical, oil refining, steel making, and other industries, and is not regulated by Pharmacopoeia and the FDA, and cannot be used as a drug.

Impurity control is indispensable

The biggest difference between medical oxygen and industrial oxygen in the production process is impurity control.

GMP also has strict regulations for the production and filling equipment of medical oxygen. The gas compression equipment in the production process is prohibited to use fluorine plastic piston seal compressors and water-lubricated compressors to avoid producing gases harmful to the human body; the filling should have special equipment, and the filling clamps should also have anti-misfiling devices.

If the patient inhales oxygen adulterated with harmful impurities, it will not only fail to achieve the expected therapeutic effect, but also cause damage to the respiratory tract, trigger or aggravate respiratory diseases, and even threaten the patient's life safety - often it is the slightest difference that can determine the life and death of the patient.

 

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