Overview

Carbon dioxide monitoring in pharmaceutical manufacturing encompasses process control applications, environmental monitoring, and safety considerations. CO₂ serves both as a process gas and as a critical parameter requiring control in various manufacturing operations.

Applications in Pharmaceutical Manufacturing

pH Control – Buffered systems and fermentation pH adjustment
Supercritical Extraction – Supercritical CO₂ for natural product extraction
Packaging Applications – Modified atmosphere packaging for stability
Cell Culture – Incubator atmosphere control (5-10% CO₂)
Carbonation – Effervescent tablet manufacturing
Precipitation – Anti-solvent crystallization processes

Quality Specifications

USP Carbon Dioxide Specifications

Identification: Method A
Carbon Dioxide Content – Not less than 99.0% CO₂ by volume
Limit of Nitrogen Dioxide – Not more than 2.5 ppm
Limit of Nitric Oxide – Not more than 2.5ppm
Hydrogen Sulfide – Not more than 1 ppm
Ammonia – Not more than 0.0025%
Carbon Monoxide – Not more than 0.001%
Sulfur Dioxide – Not more than 5ppm
Water Content – Not more than 150 mg/m³

Other considerations

Oil Content – Not more than 1 mg/m³
Particulate Matter – Class 1 per ISO 8573-1
Bioburden

Food Grade CO₂ (for pharmaceutical excipients)

Purity – 99.9% minimum CO₂
Moisture – <20 ppm H₂O
Total Hydrocarbons – <50 ppm as methane
Sulfur Compounds – <0.1 ppm as H₂S
Aldehydes – <0.2 ppm as acetaldehyde
Non-volatile Residue – <10 mg/kg

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 and Regulatory Considerations

Safety Hazards