Manufacturing oxygen
So oxygen is initially manufactured at
an ASU, which is an Air Separation Unit that basically takes in atmospheric air and
separates out the gases, the components of the air by a process of distillation, so it will
take out oxygen and nitrogen primarily, and then and the other gases they will be stored
as a liquid. That liquid oxygen will then be certificated as a medical product once it has
been cleaned, and then that will be delivered to our production facility in a bulk tanker.
We will then run that through our processes, turn it back into a gas, and then we
will also analyze that gas to check for pharmacopoeia to make sure that it is still
compliant with, to be a medicine. And then we will produce certificates for that and it will
get signed off by our QPs for release to market. So the purity of medical grade oxygen is a minimum
of 99.5% pure oxygen, and then we also measure for carbon monoxide, carbon dioxide, and moisture
levels as well, and they all have set limits that they have to meet, the gas has to meet to be
able to pass as a medical-grade gas. So that is the difference between a medical-grade gas and,
say, an industrial gas, is that we are working specifically to pharmacopoeia and our products
are all monitored through their life cycle for any adverse reactions and things like
this because it is a licensed product.
Manufacturing and Certification of Medical Oxygen
1. Oxygen Production at ASU
Initial Manufacturing:
- Oxygen production begins at an Air Separation Unit (ASU).
- The ASU takes in atmospheric air and separates its components through distillation.
- Primarily, oxygen and nitrogen are extracted, while other gases are stored as a liquid.
2. Certification as a Medical Product
Certification Process:
- The liquid oxygen undergoes a cleaning process.
- It is then certified as a medical product.
- Transported to the production facility in bulk tankers.
3. Transformation into Medical-Grade Gas
Conversion to Gaseous Form:
- At the production facility, the liquid oxygen is transformed back into a gas.
- The gas is analyzed for compliance with pharmacopoeia standards.
4. Ensuring Purity and Compliance
Quality Control Measures:
- Medical-grade oxygen must have a minimum purity of 99.5%.
- Additional checks include monitoring carbon monoxide, carbon dioxide, and moisture levels.
- All parameters must meet specified limits to maintain medical-grade status.
5. Ongoing Monitoring and Compliance
Licensing and Product Lifecycle:
- Medical-grade oxygen is rigorously monitored throughout its lifecycle.
- Continuous assessments are conducted to detect and address any adverse reactions or issues.
- Due to its licensed status, strict quality control is maintained.