Medical Oxygen Testing

Objective of Medical-Use Oxygen Test

Medical gases are used for different medical purposes, their different uses are for treatment, during anesthesia, and for driving medical devices and tools. There are 7 kinds of gases commonly used: Oxygen, Nitrogen, Nitrous oxide, Argon, Helium, Carbon dioxide, and Compressed air. Different industries, including health systems, use oxygen regularly. Oxygen in the market is available for industrial and medical use. Medical-use oxygen is very different from industrial oxygen in purity and quality. Thus, industrial and medical use are not interchangeable.

"Industrial oxygen is not intended for human use. Solely medicinal oxygen that was tested to meet authorized specifications for its identity, purity, and content and that was produced, stored, and distributed following appropriate practices should reach the patient. Uncertainties regarding the purity and content of industrial oxygen, the possible occurrence of particulate and microbial contamination, and production, storage and distribution processes that may not be appropriately planned, performed and controlled can result in unacceptable risks for patients." -WHO

Medical-Use Oxygen

Depending on the source and production method medical oxygen has the following values:

1. For oxygen produced by the air-liquefaction process, the International Pharmacopoeia(US & EPA), defines the requirements of medical-use oxygen. Currently, oxygen must contain not less than 99.5% v/v of O2.

2. For Pressure Swing Adsorption (PSA) plants, the WHO interim guidance technical specifications for PSA plants, published in June 2020, specifies: "pressure swing adsorption technology to produce medical oxygen 93%±3 from ambient air"

3. For Oxygen concentrators, the WHO-UNICEF technical specifications and guidance for oxygen therapy devices, published in 2019, as one of the sources of oxygen. “The concentrator should delivery of low-flow, continuous, clean, and concentrated oxygen (> 82%) from room air (21%).” This same statement was published in WHO interim guidance of the WHO list of Priority Medical devices for COVID-19 and its associated technical specifications, published in November 2020.

Oxygen is an Essential Medicine

Healthcare professionals use oxygen to treat respiratory illnesses like COVID-19 and pneumonia. Oxygen is also essential for surgery and trauma. Vulnerable groups like the elderly, pregnant women and new-born need oxygen regularly.
Many levels of the health systems need medical oxygen. The units in the health system that uses oxygen include:

• Primary health care
• General wards
• Emergency transport
• Delivery rooms
• Operating theaters
• Intensive care units (ICU)
• Specialized hospitals
• Outpatient units

Acceptable Medical-Use Oxygen in India

Medicinal Oxygen is a scheduled drug as per Schedule ‘M’ of the Drugs and Cosmetics Acts and Rules of India.
The Indian Pharmacopoeia covers the identity, purity & composition of Medicinal Oxygen.
The testing protocol as demanded by Indian Pharmacopoeia in its latest edition IP 2018 should be followed in Oxygen I.P. (Medical Oxygen).

Within the Indian Pharmacopoeia, there is a special monogram “OXYGEN 93%”, which is particularly for Oxygen generated from PSA Plants. This monogram requires that:

• OXYGEN PURITY: 93% (+) 3%
• CARBON DIOXIDE: Less than 300 ppm
• CARBON MONOXIDE: Less than 5 ppm

PSA Plants - Sample Testing

The user/supplier/tendering agency will get the sample analysis report of the PSA Oxygen Generation Plant output from a third-party NABL-approved Lab. The third-party NABL test report will be inspected by the hospital authority or authorized team as per the above parameters defined in Indian Pharmacopoeia 2018.

This test will be carried out within 15 days from the date of the commissioning of the PSA Plant.

Please contact us for your medical gases testing requirements with GMP copliances.