Duredunty  Filter Cartridges use a double-layer PES membrane which provides great reliability in filtration and sterilization. They are designed for the filtration of a broad range of pharmaceutical products and the removal of particles, cysts, oocysts and bacteria in aqueous filtration filtration application, while providing superior low rates and high particle removal efficiency when compared to other sterilizing grade filter cartridges.

Features and Benefits

• Double-layer hydrophilic PES membrane which requires no pre-wetting
• Asymmetric pre-filter layer provides longer service life and lower filtration cost
• Broad chemical compatibility (pH 1-14)
• Provides 10x the safety when compared to normal PES filters
• Design allows for multiple autoclave cycles (up to 30) and extended use
  
  
  

Quality Standards:

• Bacterial quantitative retention of 10⁷ CFU/cm² Brevundimonas Diminuta (ATCC 19146) according to ASTM F838 methodology .
• 100% Integrity testing in manufacturing .
• Each filter is fully traceable with unique serial number.

• Manufactured in a facility which adheres to ISO 9001: 2015 Practices .
  • Bacterial Endotoxin : Aqueous extraction of autocalved filter contains <0.25 EU/ml as determined by Limulus Amebcyte 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 requirement of USP <87> In Vitro Cytotoxicity Test ; Meet the Criteria of USP<88> Biological Reactivity Test for Class VI-121℃ plastics

  • TOC/Conductivity at 25 ℃：Autoclaved filter effluent meet the USP<643> for Total Organic Carbon and USP<645> for

  • Water Conductivity per WFI requirements after a UPW flush of specified volume .

  • Particle Shedding : Autoclaved filter effluent meet the USP<788>for large volume Injections .

  • Indirect Food Additive：All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182 , and EU framework regulation [1935/2004/EC].

  
  

Typical Applications

• Biological Vaccines

• Blood Products

• LVP and SVP

• Lyophilization Freeze-dried Powder

• Ophthalmic Solutions

• Sterile API