Super-Dura Filter Cartridges are designed for the majority of pharmaceutical liquids, but especially for solvent-containing liquids and ophthalmic solutions. These filters are composed of a hydrophilic PTFE membrane which provides great chemical and heat tolerance.

Features and Benefits

• Hydrophilic PTFE membrane which requires no pre-wetting
• Great chemical compatibility especially for solvent-containing liquids
• Minimal preservative binding in ophthalmic solutions
• Clean membrane with very low gravimetric extractable

  
  

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

• Antibiotics

• LVP & SVP
  

• Ophthalmic Solutions

• Disinfectants and Sanitizing Agents

• Large Batch Solutions

• Solvent-containing Liquid