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SPSHR Sterilizing-Grade Liquid Filter

Cobetter SPSHR series filters have ultra-low diffusion flow levels, establishing integrity values associated with bacterial challenges to ensure sterile effectiveness. Each filter element is strictly tested for bubble point and diffusion flow during manufacturing, providing a complete set of verification guidelines for customer verification. The SPSHR series of filters has a full line of scalable products, suitable for all stages from research and development to production, to accelerate the product to market.
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Description

Features

  • Good hydrophilicity for easy wetting test
  • Each filter cartridge has an independent serial number, which can fully trace the production history of the product
  • Excellent temperature resistance
  • 100% integrity test before delivery to ensure the integrity of the filter and sterilizing effect


Applications

  • Sterile filtration of LVP, SVP
  • Sterile filtration of large quantities of liquid medicine
  • Buffer sterile filtration
  • Sterile filtration of water-based antibiotic materials

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
0.40 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"
69 mm 0.1 μm 0.58 m2
69 mm 0.22 μm 0.58 m2
69 mm 0.45 μm 0.58 m2


Integrity Standard @10inch，20°C

Membrane Pore Size Bubble Point Diffusion Flow (Air)
0.1 μm ≥ 0.38 MPa (water), Air test ≤ 25 ml/min @ 0.345 MPa (water)
0.22 μm ≥ 0.32 MPa (water), Air test ≤ 25 ml/min @ 0.275 MPa (water)
0.45 μm ≥ 0.20 MPa (water), Air test ≤ 25 ml/min @ 0.15 MPa (water)


Bacterial Retention

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


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


Ordering Information

Outer Diameter Type Membrane Pore Size End Cap Nominal Length Seal Material Industry
69mm SPSHR 0010   0.1μm DOE   Double Open End 05   5 inch S   Silicone P

0022    0.22μm HTF   222/Fin 10   10 inch E   EPDM

0045   0.45μm HSF   226/Fin 20   20 inch V   Viton

HTCG   222/Flat 30   30 inch P   FEP/PFA encapsulated O-rings

HSCG   226/Flat 40   40 inch

* Example：SPSHR0010DOE05SP (SPSHR，0.1μm，Double open end，5 inch，Silicone，Pharmaceutical)

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