N₂ purge for vials, ampoules, blister packs, and IV bags. GMP-compliant with full 21 CFR Part 11 audit trail, HEPA filtration, and real-time O₂/particle monitoring.
FDA 21 CFR Part 11 compliant with electronic signatures, audit trails, and data logging. Complete validation documentation (IQ/OQ/PQ) included.
HEPA-filtered N₂ with 0.003 µm filtration at point-of-use. Zero viable particles in sterile filling zone. All wetted materials are 316L electropolished.
Continuous O₂, dew point, and particle count monitoring with automatic alarm and shutdown if parameters exceed validated limits. SCADA integration ready.
On-site GMP N₂ generation reduces cost vs. delivered high-purity N₂ by 40–60%. No cylinder handling in classified cleanroom areas.
Oil-free compressor
Multi-stage filtration + drying
PSA at 99.99%+ purity
0.003µ HEPA + catalytic purification
Electropolished 316L piping
| Parameter | Value |
|---|---|
| N₂ Purity | 99.99% – 99.999% |
| Filtration | 0.003 µm HEPA |
| O₂ Monitoring | Online, ±0.1% accuracy |
| Dew Point | −60°C (point-of-use) |
| Data Logging | 1 year (21 CFR Part 11) |
| Materials | 316L electropolished |
N₂ headspace purge before sealing. O₂ residual <1% ensures drug stability.
Inert atmosphere for moisture-sensitive tablets and capsules. N₂ flush before heat seal.
N₂ purge removes oxygen from IV solution bags. Extends shelf life.