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DN66TC /NY6TC Sterilizing-Grade Liquid Filter

The membrane of the DN66TC / NY6TC cartridge is made of hydrophilic nylon 66, which is mainly used for bio-burden reduction and sterile filtration of the final material. The nylon cartridge can filter ammonia, methyl ethyl ketone, cyclohexanone and other solvents with good chemical stability.
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Description

Features

  • Not charged
  • Naturally hydrophilic
  • Low adsorption

Applications

  • Pharmaceutical sterile filtration
  • Solvent filtration
  • Alkaline 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

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"
DN66TC 71 mm 0.22+0.22 μm 0.62 m²
71 mm 0.45+0.22 μm 0.62 m²
71 mm 1.0+0.45 μm 0.62 m²
NY6TC 71 mm 0.22 μm 0.84 m²
69 mm 0.45 μm 0.68 m²


Integrity Test Standards @10inch,20°C (DN66TC)

Mmembrane Pore Size Bubble Point Diffusion Flow (Air)
0.22+0.22 μm ≥ 0.30 MPa (water), Air test /
0.45+0.22 μm ≥ 0.30 MPa (water), Air test /
1.0+0.45 μm ≥ 0.14 MPa (water), Air test /


Integrity Test Standards @10inch,20°C (NY6TC)

Membrane Pore Size Bubble Point Diffusion Flow (Air)
outer diameter 71 mm-0.22 μm ≥ 0.32 MPa, Wetted with water, Air test /
0.45 μm ≥ 0.14 MPa, Wetted with water, Air test /


Bacterial Retention

Model Content
DN66TC 0.22+0.22 μm Bacterial quantitative retention of 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
DN66TC 0.45+0.22 μm
71NY6TC 0.22 μm Bacterial quantitative retention of 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
71NY6TC 0.45 μm Bacterial quantitative retention of 10⁷ cfu/cm² Serratia marcescens (ATCC14756) according to ASTM F838 methodology.


Sterilization

In-line steam sterilization Up to 50 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

DN66TC (Double -layer)

Outer Diameter Type Membrane Pore Size End Cap Nominal Length Seal Material Industry
   69mm DN66TC 2222   0.22+0.22 µm DOE   Double Open End 05   5 inch S   Silicone P
71   71mm 4522   0.45+0.22 µm HTF   222/Fin (PBT insert) 10   10 inch E   EPDM
1045   1.0+0.45 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


NY6TC (Single-layer)

Outer Diameter Type Membrane Pore Size End Cap Nominal Length Seal Material Industry
   69mm NY6TC 0010   0.1 µm DOE   Double Open End 05   5 inch S   Silicone P
71   71mm
0022   0.22 μm HTF   222/Fin (PBT insert) 10   10 inch E   EPDM

0045   0.45 μm HSF   226/Fin (PBT insert) 20   20 inch V   Viton

0065   0.65 μm HTCG   222/Flat (PBT insert) 30   30 inch P   FEP/PFA encapsulated O-rings

0080   0.8 μm HSCG   226/Flat (PBT insert) 40   40 inch

0100   1.0 μm


0300   3.0 μm


0500   5.0 μm


* Example:DN66TC2222DOE05SP (DN66TC,0.22+0.22µm,Double open end,5 inch,Silicone,Pharmaceutical)

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