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DLHPFB Hydrophilic PTFE Sterilizing-grade Filter Cartridge φ69mm, Solvent Filtration

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Part No. DLHPFB0022HSCG05SP
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*Not for medical use

Cobetter DLHPFB filter is designed for sterile filtration of the majority of pharmaceutical liquids, especially for solvent-containing liquids and ophthalmic solutions.

Features

  • Hydrophilic PTFE membrane which requires no pre-wetting
  • Excellent chemical compatibility(pH 1-14), especially suitable for solvent-containing liquid filtration
  • Low preservative-adsorption with ophthalmic solutions
  • Very low extractables/leachables

Applications

  • Antibiotic sterile filtration
  • Disinfectant and sanitizing agent sterile filtration
  • Water-based or organic solvent-based liquid sterile filtration
  • Ophthalmic solution sterile filtration
  • Liquid sterile filtration

Quality Standards

  • ISO 9001: 2015 Quality Management System
  • Manufactured for use in conformance with cGMP
  • Each product is integrity tested prior to release
  • Unique serial number for full traceability
  • COA/COQ provided with shipment
  • Validation documents are available upon request
Physical Properties Filter Format Cartridge Filter
Scale Production Scale
Filtration Area 0.22 μm: 0.56 m² / 10"
0.45 μm: 0.65 m² / 10"
Pore Size 0.22 μm, 0.45 μm
Bubble Point 0.22 μm: ≥0.30 MPa at 20 °C, air, wetted with water
0.45 μm: ≥0.20 MPa at 20 °C, air, wetted with water
Materials Membrane Material Hydrophilic Polytetrafluoroethylene (PTFE)
Support Fleece Polypropylene (PP)
Housing Polypropylene (PP)
O-ring / Seal Silicone
Operating Conditions Max. Differential Pressure (Forward) 0.69 MPa at 25 °C
0.4 MPa at 60 °C
0.24 MPa at 80 °C
Max. Differential Pressure (Reverse) 0.3 MPa at 25 °C
0.1 MPa at 80 °C
Max. Operating Temperature 80 °C
Regulatory Compliance Compliance USP <788> Particulate Matter
USP <87> Cytotoxicity
USP <88> Biological Reactivity
FDA Indirect Food Additives, 21 CFR 177-182
ADCF Materials
Bacterial Retention 10⁷ cfu/cm² Brevundimonas diminuta (ATCC 19146) according to ASTM F838
Bacterial Endotoxin Endotoxin Limit of WFI System<0.25 EU/mL with the Limulus Amebocyte Lysate (LAL), USP <85>
Non-Fiber Releasing The products meet the criteria as defined in 21 CFR 210.3(b)(6)
Sterility Delivery Condition Non-sterile
Sterilization Method Can be steam-in-place for 30 minutes at 135°C with 35 cycles (<30kPa)
Can be autoclaved 120 cycles for 30 minutes at 130°C
Package Pack Size Pack of 1
Packaging Individually packed in a double PE bag

 
What is the difference between nominal-rated membranes and absolute-rated membranes?

Nominal-rated membranes and absolute-rated membranes differ in manufacturing processes and materials. PP and GF membranes are nominal-rated and are typically used for clarification to remove visible particles, but they cannot be subjected to integrity testing. PES, PVDF, PTFE, and nylon are mostly absolute-rated membranes. They are generally used for bioburden reduction or sterile filtration of liquid and gas, with established standards for integrity testing.

How to define sterilizing-grade filters?

Sterilizing-grade filters are required to produce a sterile filtrate in a standard microbial challenge test (1 × 10⁷ CFU/cm² of Brevundimonas diminuta) and to establish a clear correlation with a practicable non-destructive physical integrity test. Such filters are commonly described as having a nominal pore size of 0.2/0.22 µm.

Can a 0.45 µm filter achieve complete sterilization?

A 0.45 µm absolute-rated filter can remove larger bacteria and microorganisms, with a removal efficiency of greater than 90%, and therefore can only be classified as a bioburden-reducing (or bacteria-reducing) filter. To achieve complete bacterial removal, a 0.22 µm absolute-rated filter is recommended.

What materials and filter formats are available for Cobetter sterilizing-grade filters?

Cobetter offers sterilizing-grade filters made from PES, PVDF, PTFE, and other membranes. The available formats include syringe filters, capsule filters in various sizes, and cartridge filters.

What are the advantages and benefits of Cobetter sterilizing-grade filters?

1. Gradient pore structure design, which enhances filtration flux and dirt-holding capacity.
2. Low extractables and leachables, with low protein binding.
3. Available in single-layer or composite membrane configurations.
4. Comprehensive product range and multiple connection options, suitable for a wide variety of application scenarios.