Manufacturing oxygen
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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.