USP Class VI Coalescing Media: Unmatched Biocompatibility for Critical Applications
Product Introduction
The USP Class VI Coalescing Media is a cutting-edge filtration solution designed to meet the stringent biocompatibility and purity requirements of industries where human safety is paramount. Engineered for applications in natural gas processing, aviation fuel purification, hydraulic systems, and medical/pharmaceutical environments, this media ensures the highest level of contaminant removal while adhering to the US Pharmacopeia (USP) Class VI standards for biological safety. Its inert materials, high thermal stability, and zero extractable contaminants make it the gold standard for industries where even trace impurities could compromise product integrity or human health.
Key Features & Advantages
1. USP Class VI Certification
Biocompatible Materials: Passes rigorous tests for cytotoxicity, irritation, and systemic toxicity (as per USP 88), ensuring no harmful leachables or extractables.
FDA-Compliant Polymers: Constructed from PTFE, PVDF, or FDA-grade stainless steel (316L), validated for direct contact with pharmaceuticals, food, and medical devices.
2. Ultra-High Filtration Efficiency
Beta Ratio (β) > 50,000: Removes 99.999% of droplets ≥0.01 μm, including submicron contaminants in critical fluids (e.g., water in aviation fuel, particulates in hydraulic oil).
Multi-Layer Design: Combines hydrophobic/hydrophilic coatings and electrostatic fibers for superior droplet capture and merging.
3. Extreme Environmental Tolerance
Temperature Range: -80°C to +260°C (-112°F to +500°F), with cryogenic variants for LNG applications.
Pressure Resistance: Rated for up to 300 bar (4350 psi) in high-pressure systems (e.g., refinery gas scrubbers).
4. Longevity & Cost Efficiency
5. Global Regulatory Compliance
Certifications: USP Class VI, FDA 21 CFR, ISO 10993 (biocompatibility), NSF/ANSI 61 (drinking water), and PED 2014/68/EU.
Working Principle
The USP Class VI Coalescing Media operates through a three-step process:
1. Contaminant Capture
Fluid (gas or liquid) enters the media and flows through a bed of bio-inert fibers. Submicron droplets (0.01–5 μm) collide with fibers via turbulent flow and electrostatic attraction, adhering to the surface.
2. Coalescence (Merging)
Captured droplets merge into larger aggregates (50–1000 μm) due to the media’s tortuous pathways and hydrophobic/hydrophilic coatings. This ensures efficient separation even in emulsified or high-viscosity fluids.
3. Separation & Discharge
Gravity Separation: Enlarged droplets settle at the bottom of the housing (e.g., water in natural gas, free water in hydraulic oil).
Clean Fluid Exit: Purified gas/liquid exits through the upper outlet, while collected contaminants drain via an automated valve or manual port.
Application Scenarios
1. Natural Gas Processing (Biogas/H₂S Removal)
Challenge: Biogas from landfills or wastewater treatment contains H₂S, siloxanes, and water vapor, which corrode pipelines and violate USP/USDA standards for fuel-grade gas.
Solution: Removes 99.99% of H₂S and water (β>50,000), ensuring compliance with ASTM D1655 and USP Class VI for medical-grade methane applications.
2. Aviation Fuel Purification (Aerospace Standards)
Challenge: Jet fuel (Jet A-1) must be free of free water, particulates, and surfactants to prevent icing and engine corrosion. USP Class VI compliance is critical for medical evacuation flights.
Solution: FFKM seals and fluoropolymer media ensure <1 ppm free water and <0.3 μm particulate removal, meeting DEF STAN 91-91 and FDA 21 CFR §177.2600.
3. Hydraulic Systems (Medical Devices)
Challenge: Hydraulic actuators in medical devices (e.g., surgical robots) require oil purity to avoid contamination risks. Water ingress or particle contamination risks patient safety.
Solution: Breaks emulsions, reduces water content to <10 ppm, and extends oil life by 60% in USP Class VI-compliant systems.
Technical Data
Parameter | Specification |
|---|
Model | UPC-900 (Single-Stage), UPC-1200 (Multi-Stage) |
Fluid Type | Natural gas, aviation fuel, hydraulic oil, pharmaceutical solvents, biogas |
Operating Pressure | 1–300 bar (14.5–4350 psi) |
Temperature Range | -80°C to +260°C (-112°F to +500°F); cryogenic variant: -196°C (LNG) |
Flow Rate | 200–200,000 Nm³/h (gas); 100–10,000 GPM (liquid) |
Beta Ratio (β) | β≥50,000 @ 0.01 μm; β≥100,000 @ 0.05 μm |
Removal Efficiency | 99.999% for 0.01–3 μm droplets; 99.9999% for >3 μm |
Chemical Resistance | H₂S, CO₂, HCl, ammonia, alcohols, and more |
Lifespan | 48–72 months (high-purity environments) |
Certifications | USP Class VI, FDA 21 CFR, ISO 10993, NSF/ANSI 61, PED 2014/68/EU |
Maintenance Guidelines
1. Routine Inspection
2. Media Replacement
Use OEM-certified USP Class VI media to maintain biocompatibility.
For multi-stage systems, replace all media simultaneously to avoid flow imbalances.
3. Cleaning Protocols
Gas Service: Flush with dry nitrogen or compressed air to remove residual contaminants.
Liquid Service: Soak in a mild detergent solution (e.g., isopropyl alcohol for hydraulic oil), then rinse with deionized water.
4. Troubleshooting
Low Efficiency: Check for media fouling (excessive ΔP) or chemical incompatibility (e.g., incompatible additives in fuel).
Leaks: Tighten flange bolts to torque specs or replace degraded FFKM seals.
8 Frequently Asked Questions (FAQs)
1. What makes this media “USP Class VI” compliant?
It passes tests for systemic toxicity, intracutaneous reactivity, and implantation in live animals, ensuring no harmful biological response.
2. Can it handle high-temperature steam sterilization?
Yes. Rated for SIP (Steam-In-Place) up to 134°C (273°F), meeting ISO 17665-1 for medical device sterilization.
3. Is it suitable for pharmaceutical-grade water filtration?
Yes. Meets USP <1231> water-for-injection (WFI) standards, removing endotoxins and particulates.
4. What is the maximum contaminant concentration it can handle?
Handles up to 50% emulsified water-in-oil mixtures and 10,000 ppm particulates in aggressive fluids.
5. Does it comply with aerospace fuel standards?
Yes. Certified to DEF STAN 91-91 and MIL-DTL-83133 for jet fuel purity.
6. How often should maintenance be performed in medical environments?
Replace media every 12–18 months or after 500 CIP cycles, whichever comes first.
7. What is the ROI for biopharmaceutical manufacturers?
Reduces contamination risks by 99%, cuts validation costs by 70%, and extends equipment life—payback in 6–12 months.
8. Can it be used for both gas and liquid streams?
Yes. Dual-phase models handle gas-liquid mixtures (e.g., natural gas condensates) and liquid-liquid emulsions (e.g., oil-water).
Conclusion
The USP Class VI Coalescing Media is the ultimate solution for industries where purity and safety are non-negotiable. From purifying biogas for medical use to protecting aerospace fuel systems and ensuring contaminant-free hydraulic fluids in medical devices, its unmatched biocompatibility, efficiency, and durability set a new industry benchmark. By investing in this technology, organizations protect patients, comply with global regulations, and achieve operational excellence.
Need a custom solution? Contact our regulatory experts today to design a coalescer tailored to your exact needs.
