Product Details

NYPC - Dual Layer Hydrophilic Nylon Membrane Cartridge

Brand SteriNyl

Media: Liquids

Micron Ratings: 0.2 to 0.45 µm

Filter Type: Pleated Membrane

Masterfilter NYPC 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 Benefits

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 and Biologicals

Technical Specification

Materials of construction
Membrane: Double layer Nylon 66
Support Layers: Polypropylene
Inner core: Polypropylene
Outer cage: Polypropylene
End caps: Polypropylene
O-Rings: Silicone, EPDM

Operating parameters
Maximum differential pressure: 6.9 bar (25°C), 4.0 bar (60°C), 2.4 bar (80°C)
Hot Water sanitisation: 80°C
Steam sterilisation: up to 10 cycles for 20’ (121°C)
Autoclave: up to 10 cycles for 30’ (121°C)
Filtration Area 10” Module: 0,58 m²

Applications

Fermentation
LVP (Large Volume Parenterals)
SVP (Small Volume Parenterals)
Pharmaceutical Water Treatment
Ophthalmics
API (Active Pharmaceutical Ingridients)

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