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.