Product Details

NYTC - Non Charged Nylon Membrane Cartridge
Brand SteriNyl
The Masterfilter SteriNyl NYTC series filter cartridge is made of a dual layer hydrophilic non charged Nylon 66 membrane. They are specifically designed for sterilising filtration of Pharmaceutical and Biological products and for bioburden reduction.
Nylon 66 non charged membrane provides enhanced retention of very fine particles such as endotoxins in water-based solutions.
Features Benefits
- Intrinsically water wettable
- Low pressure drop and high flow rate
- Long service life
- Integrity test values ensure a fully reliable filtration efficiency
- Double layer
Markets
- Pharmaceuticals and Biologicals
Technical Specification
Materials of Construction
Pre-Filter media: Hydrophilic Nylon
Final Filter media: Sterilizing-Grade hydrophilic Nylon
Core / cage: Polypropylene
End caps: Polypropylene
End cap insert: PBT
O-rings: Silicone, EPDM, Viton, FEP/PFA encapsulated
Operating Parameters
Maximum operating pressure: 6.9 bar at 25 °C, 4.0 bar at 60 °C, 2.4 bar at 80°C
Maximum differential pressure forward: 6.9 bar at 25 °C, 4.0 bar at 60 °C, 2.4 bar at 80°C
Maximum differential pressure reverse: 3.0 bar at 25 °C, 1.0 bar at 80°C
Steam sterilisation: up to 50 cycles for 30 min at 121 °C, differential pressure < 0.3 bar
Effective Filtration Area 10” Module: 0.62 m²
Applications
- Fermentation
- LVP (Large Volume Parenterals)
- SVP (Small Volume Parenterals)
- Pharmaceutical Water Treatment
- Ophthalmics
- API (Active Pharmaceutical Ingridients)
Filter Properties
- Bacterial Endotoxin: Aqueous extraction of autoclaved filter contains < 0.25 EU/mL as determined by Limulus Amebocyte Lysate (LAL), USP <85>
- Non-fiber Releasing: Component materials meet the criteria for a “Non-fiber-releasing filter” as defined in 21 CFR 210.3 (b) (6)
- Component Material Toxicity: Meet the criteria of the USP <88> Biological Reactivity Test for Class VI-121 °C plastics
- Bacterial Retentation: Retention > 107 cfu/cm2 Brevundimonas diminuta (ATCC 19146) according with ASTM FB38
- Indirect Food Additive: All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
- Extractables (NVR): < 13 mg/10” module