NYPC - Dual Layer Hydrophilic Nylon Membrane Cartridge Filter
Masterfilter NYPC series filter cartridge is made of a dual layer hydrophilic Nylon 66 membrane. They are specifically designed for sterilizing filtration of pharmaceutical and biological products and for bioburden reduction. Nylon 66 membrane with positive Zeta-charge provides enhanced retention of very fine particles such as endotoxins in water-based solutions.
Features
- Intrinsically water wettable
- Nylon 66+ enhanced filtration efficiency
- Nylon 66+ removal of endotoxins thanks to the formation of positive charged Zeta sites
- Low pressure drop and high flow rate
- Longer service life
- Integrity test values ensure a fully reliable filtration efficiency - Double layer
Markets
- Pharmaceuticals & Biologicals
Applications
- Fermentation
- Large Volume Parenterals - LVP
- Small Volume Parenterals - SVP
- Active Pharmaceutical Ingredients - API
- Ophthalmics
- Pharmaceutical Water Treatment
Technical Specification
| Materials of construction | Operating parameters |
|---|---|
| Membrane: Double layer Nylon 66 | Maximum differential pressure: 6.9 bar (25°C), 4.0 bar (60°C), 2.4 bar (80°C) |
| Support Layers: Polypropylene | Hot Water sanitisation: 80°C |
| Inner core: Polypropylene | Steam sterilisation: up to 10 cycles for 20’ (121°C) |
| Outer cage: Polypropylene | Autoclave: up to 10 cycles for 30’ (121°C) |
| End caps: Polypropylene | Filtration Area 10” Module: 0,58 m² |
| O-Rings: Silicone/EPDM |
Filter Properties
- These products are manufactured in a facility which adheres to ISO 9001:2015 Practices
- Each individual element is tracked by series number for traceability and easy identification
- Each individual filter is integrity tested before final packaging
- Comply with the relevant requirements of EU 1935/2004 and EU directive 2002/72/EC
- Comply with USP Plastics Class VI
- 121 °C and ISO10993 equivalents
- 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 removal 0.2 µm: Retention > 107 CFU/cm² Brevundimonas diminuta (ATCC 19146) according with ASTM f838 - Extractables: < 30 mg / 10” module