10 Inch PVDF Hydrophilic Biopharmaceutical Grade Capsule (BPVWLX)

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The BPVWLX Capsule Filter features a single-layer, hydrophilic polyvinylidene fluoride (PVDF) membrane designed for high-throughput bioburden control and prefiltration of aqueous liquids. Its fluoropolymer membrane offers excellent chemical compatibility, making it suitable for aggressive aqueous solutions used in pharmaceutical and life science applications.

With pore sizes ranging from 0.22 to 1.0 µm and consistent construction across all formats, the BPVWLX capsule filter ensures scalable performance from lab development to full-scale production. These filters are available pre-sterilized and deliver low extractables, low endotoxin levels, and fast rinse-up.

Key Features:

• Hydrophilic PVDF Membrane: Provides high flow and broad chemical resistance for aggressive aqueous fluids.

• Bioburden Control Performance: Effective for high-protein, preservative-rich, and biologically sensitive liquids.

• High Throughput: Optimized for extended service life and efficient particle removal.

• Low Extractables: Ensures product purity with reduced contamination risk.

• Regulatory Compliance: FDA and USP Class VI compliant; non-fiber releasing per 21 CFR 210.3(b)(6) and 211.72.

• Consistent Scalability: Identical materials used across device sizes to support validation from lab to production.

Performance Parameters:

• Filtration Area (Capsule): Up to 1.0 ft² (0.09 m²) depending on capsule length

• Max Liquid Pressure: 80 psi at 68 °F (5.52 bar at 20 °C)

• Max Gas Pressure: 60 psi at 68 °F (4.14 bar at 20 °C)

• Max Operating Temp (Water): 110 °F at 30 psid (43 °C at 2.07 bar)

• Forward Pressure Limit: 80 psid

• Reverse Pressure Limit: 50 psid

• Recommended Changeout Pressure: 35 psid

Sterilization & Cleaning:

• Autoclavable at 250 °F (121 °C) for 30 minutes, 5+ cycles

• Compatible with common chemical sanitization protocols, including hydrogen peroxide, peracetic acid, and sodium hypochlorite

• Rinsed to meet <3 ppb TOC and low endotoxin levels per WFI standards

Typical Applications:

• Bioburden control in LVPs and SVPs

• Prefiltration of buffers, vaccines, and plasma-derived products

• Clarification of serum, WFI, and clean-in-place solutions