Nitrogen Generator for Pharmaceutical Industry
Our nitrogen generator for pharmaceutical industry adopts PSA (pressure-switching adsorption) technology, designed for pharmaceutical, biotechnology and sterile packaging industries, providing 99.5%~99.999% high-purity nitrogen, fully complies with the GMP, FDA 21 CFR Part 11 and ISO 13485 certification requirements, replaces liquid nitrogen tanks, reduces costs and ensures continuous gas supply safety.
Core advantages
- Sterile guarantee: The nitrogen purity reaches ISO 8573-1 Class 1 standard, meeting the oxygen content control needs of vaccine production and lyophilization processes.
- Compliance certification: Passes ASME BPVC, CE, PED certification, and supports GMP verification files (DQ/IQ/OQ/PQ).
- Energy saving and high efficiency: Energy consumption is 40% lower than traditional liquid nitrogen, continuous operation 24/7.
Technical Specifications
|
Parameter |
Standard Model (NGP-50) |
High-Purity Model (NGP-100H) |
|
Nitrogen Purity |
99.5%~99.9% |
99.99%~99.999% |
|
Flow Rate |
10~100 Nm³/h |
5~50 Nm³/h |
|
Dew Point |
≤-40°C |
≤-70°C |
|
Operating Pressure |
4~8 bar |
4~10 bar |
|
Power Consumption |
0.4 kWh/Nm³ |
0.5 kWh/Nm³ |
|
Compliance Standards |
ISO 8573-1, GMP |
FDA, ISO 13485 |
Certification and compliance
1. International certification:
- ISO 8573-1 Class 1 (no oil and dust)
- ASME BPVC Section VIII (Pressure Vessel Safety)
- CE/PED 2014/68/EU (EU Directive)
2. Pharmaceutical special projects:
- FDA 21 CFR Part 11 (Electronic Record Compliance)
- EU GMP Annex 11 (Computerized System Verification)
Why choose Shenger Gas' nitrogen generator for pharmaceutical industry?
As a professional industrial gas solutions provider, Shenger Gas has customized high-reliability nitrogen systems for pharmaceutical companies with many years of industry experience. Our nitrogen generator for pharmaceutical industry not only meets strict GMP and FDA standards, but also provides flexible configuration and full-cycle services to help pharmaceutical companies improve production efficiency and compliance.
Core advantages
1. Customized design
- Optimize the system configuration according to the cleanliness level of the pharmaceutical factory (A/B/C/D), and adapt to different process requirements such as lyophilization, filling, and packaging.
2. Worry-free after-sales support
- 3-year machine warranty + annual GMP compliance review to ensure long-term and stable operation of the equipment.
- Provide IQ/OQ/PQ verification documents to simplify the audit process of pharmaceutical companies.
3. Quick response mechanism
- Deliver key documents (URS/FAT/SAT solutions) within 48 hours to shorten project cycles.
- The professional and technical team is on standby 24 hours a day to solve emergencies.
Shenger Gas – Your trusted pharmaceutical grade nitrogen solution partner!
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