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On-site pharmaceutical-grade nitrogen generator producing 99.999% high-purity dry nitrogen gas for blanketing, purging, and blister packaging.
Output: 50 Nm³/hour of high-purity N2 gas (Expandable to 200 Nm³/hr)
The N2-50 Nitrogen Generation Plant produces continuous high-purity pharmaceutical nitrogen gas (99.999% purity) on-site from compressed ambient air using hollow-fiber membrane and pressure swing adsorption (PSA) technologies. The generated nitrogen is used for headspace purging in ampoules, nitrogen blanketing in solvent coaters, and inert gas packaging.
| Nitrogen Purity | 99.9% to 99.999% (Residual O2 < 10 ppm)Source: SAMPLE datasheet — replace with approved datasheet |
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| Flow Rate | 50 Nm³ / hrSource: SAMPLE datasheet — replace with approved datasheet |
| Pressure Dew Point | -60 °CSource: SAMPLE datasheet — replace with approved datasheet |
| Storage Vessel | 2,000 L Stainless Steel Buffer ReceiverSource: SAMPLE datasheet — replace with approved datasheet |
| Product-contact parts | AISI 316L, orbital-welded, drainableSource: SAMPLE datasheet — replace with approved datasheet |
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| Contact surface finish | ≤ 0.4, electropolished µm RaSource: SAMPLE datasheet — replace with approved datasheet |
| Non-contact structure | AISI 304, bead-blasted satin finishSource: SAMPLE datasheet — replace with approved datasheet |
| Elastomers | Silicone / EPDM to FDA 21 CFR 177.2600 and USP Class VISource: SAMPLE datasheet — replace with approved datasheet |
| Plant steam | 6-7 bar(g) saturated, drySource: SAMPLE datasheet — replace with approved datasheet |
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| Supply voltage | 415 V ±10%, 3-phase + N + PE, 50 Hz (60 Hz option)Source: SAMPLE datasheet — replace with approved datasheet |
| Compressed air | 6 bar, dry and oil-free to ISO 8573-1 Class 2:4:1Source: SAMPLE datasheet — replace with approved datasheet |
| Control system | PLC with 10-inch colour HMI, recipe management and audit trailSource: SAMPLE datasheet — replace with approved datasheet |
| Overall dimensions (L × W × H) | 3,500 × 1,800 × 3,200 mmSee GA drawing for service clearancesSource: SAMPLE datasheet — replace with approved datasheet |
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| Net weight (approx.) | 3,400 kgSource: SAMPLE datasheet — replace with approved datasheet |
| Service clearance | 1,000 mm on operator and maintenance sidesSource: SAMPLE datasheet — replace with approved datasheet |
| Noise level | < 78 dB(A) at 1 mSource: SAMPLE datasheet — replace with approved datasheet |
* Specifications may vary by model. Contact us for exact configuration.
Third-party certification of the quality management system under which every machine in the range is designed, built and tested. It certifies the process, not the performance of an individual machine.
Evidence: ISO 9001:2015 Quality Management System Certificate (PDF · 2 KB)World Health Organization guidance on good manufacturing practice, widely used as the reference for export markets and WHO prequalification.
US regulation setting the controls under which electronic records and signatures are considered trustworthy and equivalent to paper records.
Evidence: Computerised System Validation & 21 CFR Part 11 Assessment Template (on request)Industry guidance for a risk-based approach to validating GxP computerised systems, used to scope the CSV deliverables supplied with the machine.
Standard for the design, materials, fabrication and surface finish of equipment used in bioprocessing and high-purity pharmaceutical service.
All configurations
Confirms that the N2-50 design, as specified, meets the user requirement specification before manufacture begins.
GMP configurations
Documents that the machine is installed to drawing, connected to the specified utilities and calibrated.
GMP configurations
Challenges the machine across its operating ranges, alarms and interlocks to show it performs as specified.
Customer-executed; product-specific acceptance criteria
Executed by the customer with our support: a three-phase sampling programme over twelve months demonstrating consistent output quality.
All configurations; customer witnessing optional
Witnessed at our works before dispatch, so defects are corrected where the parts, tools and engineers are.
All configurations
Repeats the critical FAT checks at the customer site after installation and utility connection.
Machines with the PLC/HMI control package
Validation of the PLC/HMI control system to GAMP 5, including the 21 CFR Part 11 controls for electronic records.
| Model | StandardN2-50 Standard | N2-50 Pharma+ | N2-50 Duplex |
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| Output | Output: 50 Nm³/hour of high-purity N2 gas (Expandable to 200 Nm³/hr) | Output: 50 Nm³/hour of high-purity N2 gas (Expandable to 200 Nm³/hr) | Output: 50 Nm³/hour of high-purity N2 gas (Expandable to 200 Nm³/hr) from each of two duty/standby trains |
| GMP mode | GMP | GMP | GMP |
| Automation level | PLC with 10-inch HMI, recipe management and 21 CFR Part 11 audit trail | PLC with SCADA, online TOC and 21 CFR Part 11 data logging | PLC with duty/standby changeover and remote monitoring |
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| Part | Part no. | Type | Recommended stock | Replacement interval | Lead time |
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| Cartridge pre-filter, 5 µm | GP-UT-PFLT-N250-01 | Consumable | 1 set | 3 months or ΔP limit | 1 week |
| RO membrane element | GP-UT-ROMB-N250-02 | Wear part | 1 set | 24-36 months | 4 weeks |
| Sanitary pump mechanical seal | GP-UT-MSEL-N250-03 | Wear part | 2 nos | 12 months | 3 weeks |
| Conductivity sensor | GP-UT-COND-N250-04 | Electrical | 1 no | On failure | 3 weeks |
| Tri-clamp gasket kit, EPDM | GP-UT-GSKT-N250-05 | Consumable | 1 kit | 12 months | 1 week |
| Sterile vent filter, 0.2 µm | GP-UT-VFLT-N250-06 | Consumable | 1 no | 12 months or failed integrity test | 2 weeks |
Models, typical specification, utilities and materials of construction for the pharmaceutical utilities range. Sample content for staging; replace with the approved controlled document before go-live.
Front elevation and plan view with overall dimensions, service clearances and the utility connection schedule. Sample content for staging; replace with the approved controlled document before go-live.
Safety, installation, operation, cleaning, preventive maintenance and troubleshooting for the pharmaceutical utilities range. Sample content for staging; replace with the approved controlled document before go-live.
Protocol structure, prerequisites, test case tables and acceptance criteria for installation and operational qualification. Sample content for staging; replace with the approved controlled document before go-live.
Document review, mechanical, electrical, functional and performance checks witnessed at our works before dispatch. Sample content for staging; replace with the approved controlled document before go-live.
Installation verification, utility connection, re-test of critical FAT items and production trial at the customer site. Sample content for staging; replace with the approved controlled document before go-live.
GAMP 5 categorisation, 21 CFR Part 11 controls checklist, audit trail review and user access matrix for PLC/HMI control systems. Sample content for staging; replace with the approved controlled document before go-live.
Overview of the full range: capsule filling, tablet compression, blister packing, granulation, coating, washing, liquid filling and utilities. Sample content for staging; replace with the approved controlled document before go-live.
Guide to electronic records, electronic signatures, audit trails and access control on machine control systems. Sample content for staging; replace with the approved controlled document before go-live.
Common questions about our pharmaceutical machinery.
Get a custom quote, technical specifications, and delivery timeline from our experts.
