Specifications
  • Membrane: Hydrophilic PES
  • Support Layers: Polyester
  • Body & Core: Polypropylene
  • Final Filter Pore Size : 0.2 µm, 0.45 µm
  • Sterilisation : Autoclavable/In-line steam sterilizable at 121 °C for 30 minutes, 25 cycles.
  • Maximum Differential Pressure: 50 psi (3.5 Kg/cm²) @ 25 °C.
  • Maximum Operating Temperature: 80 °C @ < 30 psi (2 Kg/cm²)
  • Reverse Pressure:  < 10 psi (0.7 Kg/cm²) @ 25 °C
Special Features
  • Large filtration area,
  • High throughputs
  • Absolute Retention
  • Low protein binding
  • Total traceability by individual marking
  • Pre-flushed to minimize particulate release after installation
  • Non-toxic material of construction
  • Multiple autoclavable
  • Low

Polyethersulfone Membrane Cartridge Filters

NUPORE double layer PES membrane cartridge filters are specially designed for incorporating a large pore size upstream membrane.

The upstream PES membrane layer protects the downstream side PES membrane layer from premature clogging giving the high throughput.

 

Applications :

  •       • Downstream processing of Vaccines
  •       • Sterilization of Hormonal Injectables
  •       • Manufacturing of LVPs
  •       • Manufacturing of WFIs
  •       • Sterile liquid Filtration
  •       • Filtration of proteinaceous liquid where minimum protein loss is desired, such as sera, culture soups and recombinant proteins, antibodies etc.
  •       • Filtration of media, buffers etc.

  ➣   Microbially validated as per ASTM F 838-05
  ➣  Complies with USFDA 21 CFR 210.3 (b)(6)`
  ➣  Meets & Exceeds USFDA 21 CFR 177.1520

Integrity Testing / Retention
Pore Size 0.2µm 0.45µm
Bubble Point (with Water) > 50psi (3.51 Kg/cm²) > 30psi (2.11 Kg/cm²)
Air Diffusion Flow (10” Cartridge Filter) with Water < 30 ml/min @ 37 psi (2.6 Kg/cm²) < 35 ml/min @ 22 psi (1.54 Kg/cm²)
Microbial Retention (LRV > 7 for) Br. Diminuta (ATCC 19146) per cm² Serratia marcescens (ATCC 14756) per cm²

Water Flow Rates

Pore Size 0.2µm 0.45µm  
Typical  Water Flow Rates (10” Cartridge filters) 40 lpm @ 0.70 Kg/cm² @ 27 °C 55 lpm @ 0.70 Kg/cm² @ 27 °C

 

 

ASSURANCE:
Toxicity :
Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics
Cytotoxicity  :  Passes  Biological  Reactivity Tests, In Vitro, USP <87> for cytotoxicity
Bioburden  :  Bioburden  level  is  <  1000 cfu/filter device as per ANSI/AAMI/ISO 11737-
1 : 1995
Bacterial  Endotoxin  :  Aqueous  extracts exhibit < 0.25 EU/ml as established by Limulus
Amebocyte Lysate (LAL) Test  .

Non Fiber Releasing : Passes test as per USP and  comply  with  USFDA  21  CFR  Part  210.3 (b)(6) for fiber release.
Extractables with WFI : Passes test as per USP .
Oxidizable  Substances  :  Within  limits  as specified in USP.
Particle  Shedding  :  Passes  USP  test  for particulates in injectables.
TOC/Conductivity at 25 °C : Meets the WFI requirements of USP <643> for Total Organic
Carbon and USP <645> for Water.
Indirect  Food  Additive  :  All  Polypropylene components  meet  the  FDA  Indirect  Food
Additive  requirements  cited  in  21  CFR 177.1520
Good  Manufacturing  Practice  :  These products are manufactured in a facility which adheres to Good Manufacturing Practices Assurance
 

Ordering Information :

height="30"
Type Size Pore Size Adapter Rings
Membrane Code Length EFA Code Pore Size Code Adapter Code Ring Code
Polyethersulfone CFPE 5" 0.3 m² 05 0.20µm 02 7P U Silicone SS
10" 0.7 m² 10 0.45µm 045 BEO V Viton SV
20" 1.4 m² 20 28 W EPDM SE
30" 2.1 m² 30 'O' X
4463 Y
4463B Z
 

CFPE

10

45

U

SV