Pharmaceutical and analytical applications demand more than standard compressed air filtration. This Omega Air filter is specifically configured for sterile, bacteria-free and particle-free compressed air — removing microorganisms, oil aerosols, oil vapour and sub-micron particles to produce air that meets ISO 8573-1 Class 1 and GMP manufacturing requirements. Essential for tablet coating, blister packaging, fermentation, analytical instruments and any compressed air that contacts product or product contact surfaces.
| Parameter | Specification | Notes |
|---|---|---|
| Application | Pharma / Food / Analytical | Sterile and bacteria-free compressed air |
| Max Pressure | 10 bar (145 psi) | Typical pharmaceutical facility line pressure |
| Particle Removal | 0.01 µm / 99.9999% | Removes bacteria and sub-micron particles |
| Residual Oil Content | ≤0.003 mg/m³ | Exceeds ISO 8573-1 Class 1 oil requirement |
| Recommended Filter Train | P + S + ACS (3-stage) | Particulate → sterile coalescing → carbon |
| Housing Material | 316L stainless steel | Electropolished, FDA-compatible surfaces |
| Connections | BSP / Tri-clamp (hygienic) | Tri-clamp available for CIP/SIP installations |
| Operating Temperature | +1°C to +60°C (standard) | Steam sterilisable versions available |
| Element Integrity Test | DOP / forward flow (optional) | Test ports available for GMP validation |
| Compliance | ISO 8573-1 Class 1 / EU GMP Annex 1 | FSSAI, CDSCO and Indian Pharmacopoeia aligned |
Pharmaceutical and food-grade compressed air requires a multi-stage approach. Each stage removes a specific contaminant, and together they produce air that meets ISO 8573-1 Class 1 for both particles and oil — the standard demanded by regulatory bodies for product-contact air.
Compressed air contacting tablet coating pans, blister packing machines and solid dosage product lines must be bacteria-free and oil-free per GMP and Schedule M requirements.
Sterile air for bioreactors, fermenters and cell culture vessels where any microbial contamination in the air supply could destroy an entire production batch.
Zero air and carrier air for GC, HPLC, ICP-MS and mass spectrometry instruments. Oil vapour contamination at ppb levels can invalidate chromatographic results.
Direct-contact packaging air, pneumatic conveying of food powders, filling lines and carbonation systems requiring FSSAI-compliant oil-free, bacteria-free air.
Sterile manufacturing cleanrooms, aseptic fill suites and hospital pharmacy compounding areas requiring EU GMP Annex 1 compliant sterile compressed air.
Vial and ampoule filling, lyophilisation loading and stopper bowl aeration where compressed air contacts sterile product or primary packaging materials.
The P + S + ACS filtration train produces compressed air that meets ISO 8573-1 Class 1 — the highest purity class — for both oil content and particulate. This is the class required by most pharmaceutical and food-grade applications.
| ISO Class | Max Particle Count (≥0.1 µm/m³) | Max Oil Content (mg/m³) | Typical Application |
|---|---|---|---|
| Class 1 ✓ Achieved | ≤20,000 | ≤0.01 | Pharma, food contact, sterile |
| Class 2 | ≤400,000 | ≤0.1 | Electronics, painting, general |
| Class 3 | ≤90,000,000 | ≤1.0 | General industrial use |
| Class 4 | Not specified | ≤5.0 | Heavy industrial |
Our engineers will design the complete P + S + ACS filter train for your application, sizing each stage for your flow rate and ensuring full compliance with GMP, FSSAI and ISO 8573-1 Class 1.