MS Hydrophilic PVDF Membrane

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Features

Membrane Solutions PVDF hydrophilic membranes have many excellent properties, especially biocompatibility and chemical compatibility.

• Sterile filtration in the biological field
• Low protein adsorption
• Strong hydrophilicity
• Wide range of chemical compatibility
• High porosity and high flow rate
• Particle interception rate >99%
• Low dissolution

Applications

Membrane Solutions PVDF hydrophilic membranes are commonly used in protein solution filtration, various conventional filtration and sample preparation applications.

• Aseptic filtration in the biological field
• Sample preparation in HPLC
• Conventional filtration ( water and organic matter )
• Solvent filtration

Technical Parameters

FAQ

1. Basic Concepts

Q1.1: What is a PVDF hydrophilic membrane? How does it differ from a hydrophobic PVDF membrane?

A: PVDF (polyvinylidene fluoride) is inherently a hydrophobic material. A PVDF hydrophilic membrane is a product treated with hydrophilic modification technology to reduce its surface contact angle, allowing it to be directly wetted by aqueous solutions.

The key difference in terms of sterilizing filtration:

Q1.2: What are the main advantages of using hydrophilic PVDF membranes for sterilizing filtration?

A: In sterilizing filtration for biopharmaceuticals, hydrophilic PVDF membranes offer the following notable advantages:

• Extremely low extractables: The content of extractables is extremely low, minimizing the impact on drug safety and purity
• Broad chemical compatibility: Resistant to solutions across a wide pH range, alcohols, and common disinfectants
• Good heat resistance: Supports high-temperature, high-pressure sterilization, making it suitable for aseptic processes
• Low protein adsorption: Significantly lower than nylon membranes, making it suitable for filtering protein-containing feed solutions
• High mechanical strength: Good pressure resistance and low susceptibility to rupture

Q1.3: Compared to PES sterilizing filters, what are the characteristics of PVDF hydrophilic membranes?

Selection Recommendations: For terminal sterilizing filtration with extremely stringent requirements for extractables (e.g., injectables), PVDF is the preferred choice; for applications requiring high flow rates and flux, PES is recommended.

2. Usage and Operation

Q2.1: Does the hydrophilic PVDF membrane require pretreatment before use?

A: No alcohol-based pre-wetting is required: Hydrophilic PVDF membranes can be directly wetted with aqueous solutions for use

Recommended rinsing: Rinse the filtration system with purified water or water for injection prior to use to remove packaging residues or wetting agents (if present).

For final sterilizing filtration: It is recommended to operate according to validated filtration parameters (differential pressure, flow rate).

Q2.2: Which chemical reagents can PVDF hydrophilic membranes withstand?

A: PVDF hydrophilic membranes exhibit excellent chemical compatibility:

Important Note: Chemical compatibility should be verified based on the specific composition of the process fluid prior to actual use.

Q2.3: How should PVDF hydrophilic membranes be sterilized?

A: PVDF hydrophilic membranes support multiple sterilization methods:

• Autoclaving: 121°C for 30 minutes (standard conditions)
• Gamma-ray sterilization: ≤50 kGy
• Ethylene oxide (ETO) sterilization

Precautions:

• Repeated sterilization is not recommended, as it may affect membrane integrity and flow rate
• An integrity test should be performed before use following sterilization

Q2.4: What is the maximum operating temperature for PVDF hydrophilic membranes?

A: Continuous operation: Normal operating temperature ≤ 85°C

Q2.5: How is the integrity test performed on PVDF hydrophilic membrane cartridges?

A: Sterilizing-grade PVDF hydrophilic membranes (0.22 µm) use a standard aqueous phase bubble point test:

3. Performance and Validation

Q3.1: What is the bacterial retention performance of PVDF hydrophilic membranes?​

A: According to the bacterial filtration validation standard (ASTM F838), the retention capacity of 0.22 µm PVDF hydrophilic membranes for Brevundimonas diminuta is as follows:

• Retention level: ≥ 10⁷ CFU/cm²
• Retention efficiency: > 99.99%

Q3.2: What is the leachate level of the PVDF hydrophilic membrane?

A: PVDF hydrophilic membranes exhibit extremely low levels of extractables during sterilizing filtration, which is one of their core advantages:

Non-specific extractables are significantly lower than those of materials such as nylon and mixed cellulose esters

Suitable for final sterilizing filtration of high-risk, high-value injectable products

Q3.3: What is the protein adsorption level of PVDF hydrophilic membranes?

A: Modified PVDF hydrophilic membranes exhibit low protein adsorption:

Recommendations: Suitable for filtering protein solutions at standard concentrations; for extremely low-concentration, valuable proteins (such as monoclonal antibody stock solutions), it is recommended to verify recovery rates and select ultra-low-binding materials if necessary.

Q3.4: How effective is the PVDF hydrophilic membrane at removing endotoxins?

A: PVDF hydrophilic membranes have limited capacity to remove negatively charged endotoxins (LPS):

Mechanism: This is primarily achieved by the membrane’s hydrophilic surface reducing hydrophobic interactions, rather than through charge-based adsorption.

Effectiveness: They cannot remove endotoxins as efficiently as positively charged nylon membranes.

Recommendation: If specific endotoxin removal is required, positively charged nylon membranes or dedicated endotoxin removal filters should be selected; for routine sterilizing filtration, endotoxin levels should be validated according to process requirements.

4. Storage and Stability

Q4.1: How should unused PVDF hydrophilic membrane filter cartridges be stored?

A: Storage conditions: Sealed, dry, protected from light, at room temperature (25±5°C) with relative humidity < 60%

Shelf life: Typically 3 years (refer to product label)

Prohibited: Do not freeze; avoid direct sunlight

5. Selection and Application Recommendations

Q5.1: When should a hydrophilic PVDF membrane be chosen over PES or PTFE?

Q5.2: Why is hydrophilic PVDF the preferred choice for terminal sterilizing filtration?

A: Extremely low extractables: Minimal impact on drug safety and purity

Broad chemical compatibility: Tolerates a wide range of cleaning agents and process conditions

Proven reliability: Long history of successful application in the biopharmaceutical industry

Low protein adsorption: Suitable for protein-containing formulations