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DN66PC/N66PC Sterilizing-Grade Liquid Filter

Cobetter DN66PC/N66PC series filter cartridges are made of naturally hydrophilic nylon 66 membranes, which are modified with positively-charged N66 membranes to absorb and remove particles, bacteria and endotoxins that are smaller than the filter pore size.
Recommended Applications:
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Description

Features

  • Naturally hydrophilic
  • The use of modified positively-charged N66 membranes removes endotoxins from water, absorbing particles and endotoxins smaller than the filter membrane pore size.
  • Good integrity and high bubble point values ensure excellent sterilization and particle removal efficiency
  • Low pressure drop, high flow rates, long-life

Applications

  • Sterile filtration for LVP, SVP and antibiotic solutions
  • Sterile filtration of saline and other solvents
  • Filtration of pharmaceutical water and removal of pyrogens
  • Pharmaceutical sterile filtration
  • Solvent filtration
  • Alkaline solution filtration

Quality

  • 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

Evaluation of Endotoxin Absorption Efficiency

Flow Rate Characteristics

Specifications

Materials of Construction

Membrane Nylon 66
Support Polypropylene (PP), polyester (PET)
Core/Cage/End Caps Polypropylene (PP)
End Cap Inserts Polybutylene terephthalate (PBT)
Seal Material Silicone / EPDM / Viton
FEP/ PFA encapsulated O-rings


Operating Conditions

Max. Operating Temperature
80°C
Max.Operating Pressure
0.69 MPa@25°C
0.40 MPa@60°C
0.24 MPa@80°C
Max. Differential Pressure (Forward)
0.69 MPa@25°C
0.40 MPa@60°C
0.24 MPa@80°C
Max. Differential Pressure (Reverse)
0.30 MPa@25°C
0.10 MPa@80°C


Filtration Area

Outer Diameter Membrane Pore Size Area/10"
DN66PC 69 mm 0.22+0.22 μm 0.58 m2
69 mm 0.45+0.22 μm 0.68 m2
71 mm 0.45+0.22 μm 0.82 m2
69 mm 1.2+0.45 μm 0.84 m2
N66PC 69 mm 0.22 μm 0.65 m2


Integrity Test Standards @10inch,20°C (DN66PC)

Membrane Pore Size Bubble Point Air Diffusion
0.22+0.22 μm ≥ 0.30 MPa (water), Air test ≤ 16 ml/min @ 0.275 MPa (water)
0.45+0.22 μm(outer diameter 69mm) ≥ 0.30 MPa (water), Air test ≤ 20 ml/min @ 0.275 MPa (water)
0.45+0.22 μm(outer diameter 71mm) ≥ 0.30 MPa (water), Air test ≤ 24 ml/min @ 0.275 MPa (water)
1.2+0.45 μm ≥ 0.12 MPa (water), Air test ≤ 18 ml/min @ 0.1 MPa (water)


Integrity Test Standards @10inch,20°C (N66PC)

Membrane Pore Size Bubble Point Air Diffusion
0.22 μm ≥ 0.30 MPa, Wetted with water, Air test /


Bacterial Retention

Model Content
69DN66PC 0.22+0.22 μm Bacterial quantitative retention of 10? cfu/cm2 Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
69DN66PC 0.45+0.22 μm
71DN66PC 0.45+0.22 μm
69DN66PC 1.2+0.45 μm Bacterial quantitative retention of 10? cfu/cm2 Serratia marcescens (ATCC14756) according to ASTM F838 methodology
N66PC 0.22 μm Bacterial quantitative retention of 10? cfu/cm2 Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.


Sterilization

In-line steam sterilization Up to 10 cycles (121 °C for 30 minutes and differential pressure <30KPa per cycle )


Regulatory Compliance

  • Autoclaved filter effluent meets the USP<788> requirement of particulate matter in large volume injection.
  • Component materials meet the criteria for a "Non-fiber-releasing filter" as defined in 21 CFR 210.3(b)(6).
  • Aqueous extraction from a cartridge contains less than 0.25EU/ml as determined by Limulus Amebocyte Lysate (LAL), meeting requirements of USP<85>.
  • Meet the requirement of USP <87> In Vitro Cytotoxicity Test.
  • Component materials meet the requirements of the current USP<88> for plastic class VI-121°C.
  • All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
  • Based on the current information from our suppliers, all component materials used in the manufacture of this product are animal-free.


End Cap


Ordering Information

DN66PC (Double-layer)

Outer Diameter Type Membrane Pore Size End Cap Nominal Length Seal Material Industry
   69mm DN66PC 0022   0.22 μm DOE   Double Open End 05   5 inch S   Silicone P
71   71mm 2222   0.22+0.22 μm HTF   222/Fin (PBT insert) 10   10 inch E   EPDM
4522   0.45+0.22 μm HSF   226/Fin (PBT insert) 20   20 inch V   Viton
1245   1.2+0.45 μm HTCG   222/Flat (PBT insert) 30   30 inch P   FEP/PFA encapsulated O-rings

HSCG   226/Flat (PBT insert) 40   40 inch


N66PC (Single-layer)

Outer Diameter Type Membrane Pore Size End Cap Nominal Length Seal Material Industry
   69mm N66PC 0022   0.22 μm DOE   Double Open End 05   5 inch S   Silicone P
71   71mm
0045   0.45 μm HTF   222/Fin (PBT insert) 10   10 inch E   EPDM

0120   1.2 μm HSF   226/Fin (PBT insert) 20   20 inch V   Viton


HTCG   222/Flat (PBT insert) 30   30 inch P   FEP/PFA encapsulated O-rings

HSCG   226/Flat (PBT insert) 40   40 inch


* Example:DN66PC2222DOE05SP (DN66PC,0.22+0.22μm,Double open end,5 inch,Silicone,Pharmaceutical)

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