Specifications

Nylon 66 membrane sterilization filter element
1.high-precision nylon 66 filter membrane
2.overall structure sweat welding

 Nylon 66 membrane sterilization filter element 

1.The filter membrane is hydrophilic with absolute filtration accuracy

2. Wide chemical compatibility

3. It has excellent applicability under high temperature condition

4.Proteins can be intercepted

5.Excellent interception rate

6.Extremely low precipitates

 

1.sterile filtration of raw material medicine,injection,infusion and other drug

2.Terminal sterile filtration of food,drink and wine

3.Terminal filtration of photoresist,chemical reagent,ect

4.Terminal filtration of water-based ink

 

 Filter element material composition:

filter memebrane	single-layer or double-layer nylon filter membrane
diversion material	polypropylene(PP)
outer shell	polypropylene(PP)
seal ring	please see filter element modle selection table

 

Intergrity test:

aperture(um)	0.05	0.1	0.2	0.3	0.45
the lowest bubbling point in pure water(MPa)	≥0.70	≥0.51	≥0.32	≥0.28	≥0.18

 

Main application technical indicators:

maximum operating temperature	85°c/0.1MPa
maximum operating pressure difference	0.42MPa/25°c
recommended operating pressure difference	0.1~0.2MPa/25°c
maximum back-pressure difference	0.2MPa/25°c
effective filtration are(10 inches)	≥0.6m²
forward online steam sterilization(135°c)	30min/time
disinfection by disinfection cabinet(121°c)	30min/time

 

Water flow capacity-pressure difference curve(10'' filter element)

  Quality assurance:

 

 

1.ISO9001: 2008 guaranteed quality management system

 

2.Traceability management system of each filter

 

3.Filter elements are flushed and pass integrity test before filter elements are left from the factory

 

4.The batch passes through bacterial challenge test for confirming 100% bacteria interception ability

 

Biological safety: 

 

1.Biological Safety: The product materials comply with USP in-vivo VI-121 ℃ plastic biological response test

 

2.Endotoxin: <0.25EU/ml

 

3.Cleanliness: The product is in line with 2010 GMP requirements on injection of particles

 

4.Readily oxidizable substance: the substance should be in line with 2010 GMP test requirements of particle contents in injections after water rinsing for 2000ml

 

5.TOC/conductivity: after the product is flushed with 20L injection water at 25 ℃ (10"). It is in line with requirements of 2010 GMP on total organic carbon contents and conductivity in injection water.