Product Details

PES Membrane Filter Cartridge

MLSPES series polyethersulphone membrane fil-ter cartridges are specially designed for liquid sterilization in the process of pharmaceutical. The asymmetric pore structure and high voids volume of the PES membrane allow high throughputs and exceptionally high flow rates. They are ideal filter cartridge for sterilizing the aqueous solution. All of cartridges are produced in ISO Class 8 cleanroom without the use of ad-ditives or surface-active substances. All compo-nents are made of polypropylene and meet the requirements of food contact and pharmaceutical. Every piece of filter cartridge is taken integrity test, washed by pure water and have sterilized packed.

Quality and Bio-Safety

USP VI and FDA CFR21 conform Food-contact Declaration ROHS-Declaration of conformity

Extractables

≤ 50 mg per autoclaved 10-inch cartridge afte

24-h soak in purified water at controlled room temperature.

Toxicity

Component materials meet GB/T 14233.2<2005> of USP National Standard for Safety Tests

TOC

500 ppb after a water flush of 60 liters per 10-inch cartridge.

Oxidizable Substances

Meets the criteria of USP Pharmacopoeia 2010, volume for purified water.

 

Bacterial Endotoxins

< 0.25 EU/ml as determined by the LAL test

 

Applications

  • Large infusion (LVP), small injection (SVP) sterilization filtration
  • Biological product sterilization filtration
  • Sterilization filtration of serum products and plasma products
  • Sterilization of freeze-dried powder needle filtration of water for injection
  • Sterilization filtration of cleaning solution and disinfectant

Materials

  • Filter Media: Polyethersulphone (PES)
  • Support layers: Polypropylene
  • Core: Polypropylene
  • Cage: Polypropylene
  • End Caps: Polypropylene(SUS304  Ring)
  • O-rings/Gaskets: Buna-N, EPDM, Silicone, Viton, Teflon Encapsulated Viton

Features and Benefits

  • Natural hydrophilic membrane
  • High bacterial retention rate
  • High porosity and large flow rate
  • Low pressure drop
  • Low adsorption capacity and good chemi-cal compatibility
  • Easy to wet, easy to integrity testing
  • Multiply sterilized at high temperature

Specifications