Overview

Oxygen monitoring in pharmaceutical manufacturing serves dual purposes: ensuring adequate oxygen levels for aerobic bioprocesses and confirming oxygen removal in inert atmospheres. Critical applications include fermentation, cell culture, and process safety monitoring.

Applications in Pharmaceutical Manufacturing

Fermentation Processes – Aerobic bacteria and yeast cultivation
Cell Culture – Mammalian cell growth and protein production
Oxidation Reactions – Synthetic chemistry and API manufacturing
Safety Monitoring – Confined space entry and hot work permits
Inerting Verification – Confirmation of oxygen displacement

Quality Specifications

Medical Grade Oxygen (USP)

Identification: Methods A and B
Oxygen Content – Not less than 99.0% O₂ by volume
Carbon Monoxide – Not more than 10 ppm
Carbon Dioxide – Not more than 300 ppm

Medical Grade Oxygen, 93% (USP)

Identification: Methods A and B
Oxygen Content – 90.0% – 96.0% O₂ by volume
Carbon Monoxide – Not more than 10 ppm
Carbon Dioxide – Not more than 300 ppm

Other Considerations

Moisture – Not more than 67 ppm (dew point -51°C)
Oil Content – Not more than 0.1 mg/m³
Particulate Matter – Class 1 per ISO 8573-1
Bioburden

Industrial Oxygen Specifications

Purity – 99.5% minimum for pharmaceutical processes
Impurities – Total impurities <5000 ppm
Oil and Grease – Not detectable
Particulate Matter – <0.1 mg/m³
Odor – Odorless

Sample Handling

Sample Points – Representative sampling locations in distribution system. Sample cylinders can be sampled by our trained technicians or shipped by the customer.
Supply Cylinders – may be shipped directly for testing of a batch or sampled on site.
Pressure Regulators – Two-stage pressure reduction for stable pressure.

Safety Considerations

Oxygen Hazards

Fire and Explosion Risk – Accelerated combustion in oxygen-enriched atmospheres
Material Compatibility – Oxygen-compatible materials and lubricants
Pressure Safety – High pressure oxygen systems require special handling
Personnel Safety – Respiratory protection and emergency procedures

Safety Monitoring Applications