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.