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DPSHSL Sterilizing-Grade Liquid Filter

Cobetter DPSHSL is a sterilizing grade filter. The unique double-layer hydrophilic PES membrane has excellent filtration performance and reliable bacterial retention ability. It can withstand repeated steam sterilization and fully meet the filtration requirements of pharmaceutical process.
Recommended Applications:
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Description

Features

  • The unique double-layer design ensures reliable bacterial retention
  • Excellent long service time and cost effective
  • Broad chemical compatibility (pH 1-14) to effectively handle a wide range of pharmaceutical filtration processes
  • Double-layer design extends the service life, decreases the cost of use and guarantees that the filter safety factor is increased by more than 10 times


Applications

  • Chinese medicine injection filtration
  • Sterile filtration of sterile raw materials
  • Sterile filtration of eye drops and liquids
  • Buffer sterile 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 Hydrophilic polyethersulfone (PES)
Support Polypropylene (PP)
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
0.55 MPa@50°C
0.40 MPa@60°C
0.24 MPa@80°C
Max. Differential Pressure (Forward)
0.69 MPa@25°C
0.55 MPa@50°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"
69mm 0.22+0.1μm 0.60m2
69mm 0.22+0.22μm 0.60m2
69mm 0.45+0.22μm 0.60m2
69mm 0.65+0.22μm 0.60m2
69mm 0.8+0.22μm 0.60m2
69mm 1.2+0.22μm 0.60m2
69mm 0.45+0.45μm 0.60m2
69mm 0.65+0.45μm 0.60m2
69mm 0.8+0.45μm 0.60m2


Integrity Standard @10inch,20°C

Membrane Pore Size Bubble Point Diffusion Flow (Air)
0.22+0.1μm ≥ 0.38 MPa (water), Air test ≤ 25 ml/min @ 0.30 MPa (water)
0.22+0.22μm ≥ 0.34 MPa (water), Air test ≤ 25 ml/min @ 0.275 MPa (water)
0.45+0.22μm ≥ 0.32 MPa (water), Air test ≤ 25 ml/min @ 0.275 MPa (water)
0.65+0.22μm ≥ 0.32 MPa (water), Air test ≤ 25 ml/min @ 0.275 MPa (water)
0.8+0.22μm ≥ 0.32 MPa (water), Air test ≤ 25 ml/min @ 0.275 MPa (water)
1.2+0.22μm ≥ 0.32 MPa (water), Air test ≤ 25 ml/min @ 0.275 MPa (water)
0.45+0.45μm ≥ 0.18 MPa (water), Air test ≤ 25 ml/min @ 0.16 MPa (water)
0.65+0.45μm ≥ 0.18 MPa (water), Air test ≤ 25 ml/min @ 0.16 MPa (water)
0.8+0.45μm ≥ 0.18 MPa (water), Air test ≤ 25 ml/min @ 0.16 MPa (water)


Bacterial Retention

Model Content
DPSHSL 0.22+0.1μm Bacterial quantitative retention of 10? cfu/cm2 Brevundimonas diminuta (ATCC 19146) accordingto ASTM F838 methodology.
DPSHSL 0.22+0.22μm
DPSHSL 0.45+0.22μm
DPSHSL 0.65+0.22μm
DPSHSL 0.8+0.22μm
DPSHSL 1.2+0.22μm
DPSHSL 0.45+0.45μm Bacterial quantitative retention of 10? cfu/cm2 Serratia marcescens (ATCC14756) according to ASTM F838 methodology
DPSHSL 0.65+0.45μm


Sterilization

In-line steam sterilization Up to 100 cycles (135 °C for 30 min and differential pressure < 30 kPa per cycle)
Autoclave Up to 200 cycles (130 °C for 30 min 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


Documents

  1. hollow fiber

Ordering Information

Outer Diameter Type Membrane Pore Size End Cap Nominal Length Seal Material Industry
69mm DPSHSL 2210   0.22+0.1μm DOE   Double Open End 05   5 inch S   Silicone P
2222   0.22+0.22μm HTF   222/Fin 10   10 inch E   EPDM
4522   0.45+0.22μm HSF   226/Fin 20   20 inch V   Viton
6522   0.65+0.22μm HTCG   222/Flat 30   30 inch P   FEP/PFA encapsulated O-rings
8022   0.8+0.22μm HSCG   226/Flat 40   40 inch
1222   1.2+0.22μm
4545   0.45+0.45μm
6545   0.65+0.45μm
8045   0.8+0.45μm

* Example:DPSHSL2210DOE05SP (DPSHSL,0.22+0.1μm,Double open end,5 inch,Silicone,Pharmaceutical)

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