Biopharmaceuticals

2025-04-22

Industry Characteristics

The biopharmaceutical industry has extremely high requirements for gas purity. Used in drug production, packaging, or storage, it must meet GMP standards. Nitrogen generators must be oil-free and sterile to prevent contamination. Key considerations include product cleanliness, compliance with pharmaceutical regulations, and the ability to provide a continuous and stable supply of nitrogen to ensure uninterrupted production processes.

 

Application Scenarios

Sterile preparation nitrogen packaging, oxygen control during fermentation, freeze dryer protection gas.

 

Core Requirements

1. Meets GMP Class C cleanliness requirements
2. 316L stainless steel flow path, zero bioburden risk
3. Online dew point monitoring (≤-70℃)

 

Solutions

Provides GMP-compliant nitrogen for critical processes such as sterile preparation nitrogen packaging, bioreactor oxygen control, and freeze-drying protection. Reduces the risk of drug oxidation and extends the shelf life of biopharmaceuticals; replaces liquid nitrogen tanks, eliminating supply chain disruptions; modular design adapts to cleanroom space constraints

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