Biological Nitrogen Generator
Biological nitrogen generator is a high-clean nitrogen production system specially developed for life science fields such as biopharmaceuticals and cell culture. It adopts medical grade stainless steel material and sterile design to ensure that the nitrogen output complies with GMP standards and meets the use requirements of Class A clean area. Compared with traditional nitrogen production equipment, biological nitrogen generator has significant advantages in microbial control and gas purity.
Technical breakthrough
- The first "dual-stage sterile filtration" system (0.01μm)
- Built-in online oxygen content analyzer (real-time monitoring)
- Comply with FDA 21 CFR Part 11 data integrity requirements
- Support CIP/SIP cleaning and sterilization procedures
Key Performance Parameters
|
Technical Specification |
Parameter Details |
|
Nitrogen Purity |
99.5%~99.999% (Programmable control) |
|
Cleanliness Class |
ISO 14644-1 Class 5 (Dynamic maintenance) |
|
Flow Range |
2~200Nm³/h (Multi-unit parallel operation supported) |
|
Dew Point |
≤-70℃ |
|
Particulate Control |
≤0.1μm particles <1pc/ft³ |
|
Bioburden |
≤1CFU/m³ (Gamma-ray sterilized) |
|
Certifications |
cGMP, ISO 13485, ASME BPE, EU GMP Annex 1 |
Industry solutions
Biological nitrogen generator has been successfully applied to:
- Vaccine production: bioreactor inert protection
- Monoantibacter preparation: cell culture environment control
- Gene therapy: low-temperature storage protective gas source
- Sterile filling: vacant roof replacement of cillin bottles
- Biological Laboratory: Mass Spectrometer Carrier Gas Supply
Typical customer cases
- GMP workshop renovation project of a TOP3 vaccine manufacturer in China
- Cell therapy production line of multinational pharmaceutical companies Asia R&D center
- National Biosafety P3 Laboratory Gas Supply System
Shenger Gas Professional Commitment
As a biopharmaceutical gas solutions expert, we are well aware of the requirements of sterile process:
- Material Compliance: All contact parts are made of 316L EP grade stainless steel
- Verification support: Provide a full set of IQ/OQ/PQ verification files
- Intelligent operation and maintenance: equipped with predictive maintenance systems to reduce downtime risks
- Emergency support: 48-hour fast response mechanism
Our team of engineers can provide you with:
- Clean room gas solution design
- Process Risk Assessment (FMEA)
- Annual calibration maintenance service
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