Overview
Nitrogen is the most commonly used inert gas in pharmaceutical manufacturing, providing oxygen-free environments for moisture-sensitive materials, preventing oxidation during processing, and serving as a carrier gas in various unit operations.
Applications in Pharmaceutical Manufacturing
- Blanketing and Inerting – Protection of oxygen-sensitive APIs and intermediates
- Purging Operations – Reactor vessels, storage tanks, transfer lines
- Carrier Gas – Spray drying, fluid bed processing, pneumatic conveying
- Packaging – Modified atmosphere packaging for stability
- Equipment Cleaning – Drying of cleaned equipment and vessels
Quality Specifications
Medical Grade Nitrogen, (USP) Requirements
- Identity by ID A procedure.
- Nitrogen NF – Not less than 99.0% N₂ by volume
- Oxygen Content – Not more than 1.0% O₂
- Carbon Monoxide: NMT 10ppm
- Odor: none
Medical Grade Nitrogen, 97% (USP) Requirements
- Identity by ID A procedure.
- Nitrogen NF – Not less than 97.0% N₂ by volume
- Oxygen Content – Not more than 3.0% O₂
- Carbon Monoxide: NMT 10ppm
- Carbon Dioxide: NMT 300ppm
- Sulfur Dioxide: NMT 5ppm
- Nitric Oxide and Nitrogen Dioxide: NMT 2.5ppm
- Odor: none
Other considerations
- Moisture Content – Dew point -65°C or lower
- Oil Content – Not more than 0.1 mg/m³
- Particulate Matter – Class 1 per ISO 8573-1
- Bioburden – Aerobic and Anaerobic
Sampling and Sample Preparation
- Sample Points – Multiple 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 regulation for stable pressure
