HPS-J Series

2022-12-18 Click:



  Imported high precision PES filter membrane is adopted in the product as filter media. The product is produced by overall structure sweat welding. It has excellent filtration performance and ability of completely intercepting bacteria.
Features:
●The filter membrane is hydrophilic with absolute filtration accuracy;
● Low protein adsorption performance;
● Wide chemical compatibility;
● Extremely low precipitates;

Typical applications:
● Sterile filtration of vaccine;
●Sterile filtration of blood products;
● Sterile filtration of raw material medicine, injections, infusion and other drugs;
● Filtration of cell culture medium;
● Filtration of de-ionized water;
● Terminal filtration of semiconductor wet equipment;

Quality assurance:
● ISO9001: 2008 guaranteed quality management system;
● Traceability management system of each filter;
● Filter elements are flushed and pass integrity test before filter elements are left from the factory;
● The batch passes through bacterial challenge test for confirming 100% bacteria interception ability;

Biological safety:
Biological Safety: The product materials comply with USP in-vivo VI-121 ℃ plastic biological response test.
Endotoxin: <0.25EU/ml;
Cleanliness: The product is in line with 2010 GMP requirements on injection of particles;
Readily oxidizable substance: the substance should be in line with 2010 GMP test requirements of particle contents in injections after water rinsing for 2000ml;
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.

Filter element material composition:

Filter membrane

PES filter membrane

Diversion material

Polypropylene

Outer shell

Polypropylene

Seal ring

Please see Filter Element Model Selection Table

Center rodPolypropylene or 316L stainless steel


Integrity test:

Aperture(um)

0.10.20.30.45

The lowest bubbling point in pure water(MPa)

≥0.48≥0.34≥0.25≥0.16


Main application technical indicators:

Maximum operating temperature

85℃/0.1MPa

Maximum operating pressure difference

0.42MPa/25℃

Recommended operating pressure difference

0.1-0.2MPa/25℃

Maximum back-pressure difference

0.2MPa/25℃

Effective filtration area (10 inches)

≥0.6㎡

Forward online steam sterilization (135 ℃)

30min/time

Disinfection by Disinfection cabinet (121 ℃)

30min/time