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Safeguarding Sterility — Empowering Critical Pharmaceutical Safety with Feature-Tec PES Filters
2025-10-24
The Essential Role of PES Membrane Filters in Biopharmaceutical Production
As technology advances and industrial applications diversify, the demand for high-performance filtration materials continues to rise. Polyethersulfone (PES) membranes, known for their superior chemical stability and physical properties, have become indispensable across multiple industries.
In the biopharmaceutical field—where purity and safety are paramount—PES membrane filters play a vital role in the separation, purification, and concentration of biomolecules. They effectively remove process-related impurities, ensuring both product recovery and therapeutic safety.
Why Choose the LOPAC INNOVEX SP Filter
Feature-Tec’s LOPAC INNOVEX SP series represents full-process innovation — from in-house PES membrane R&D to final filter manufacturing.
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In-house developed asymmetric PES membrane: gradient pore structure ensures bacterial retention and higher dirt-holding capacity.
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Stable and consistent performance: verified through multiple validation tests under various buffer and cell-culture conditions.
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Reliable quality: ISO-certified production and 100% integrity testing before delivery.
Typical Applications
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Sterilizing filtration of cell-culture media
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Buffer solution filtration
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Prefiltration for columns or ultrafiltration units
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Final sterilizing filtration of drug products
Application Highlights
Case 1 — Recombinant Human Collagen Filtration
LOPAC INNOVEX SP filters maintained a stable flow rate of ~18,000 LMH under 14.5 psi, achieving a Vmax capacity of 28,571 L/m², proving excellent throughput and process stability.
Case 2 — Bromfenac Sodium Eye Drops
For ophthalmic drug sterilization, the filter sustained a flux of ~14,000 LMH under 14.5 psi, with a Vmax capacity of 28,571 L/m², ensuring safe and efficient sterilization for high-value APIs.
Case 3 — Heparin Sodium Anticoagulant Filtration
Using a double-layer 0.45 + 0.22 μm PES filter, the product demonstrated Vmax = 1,666 L/m² with stable flux (~921 LMH), meeting stringent biopharma sterility and endotoxin requirements.
Core Advantages of Feature-Tec LOPAC INNOVEX SP
✅ Proven stability: batch-to-batch variation < 20%
✅ Low protein adsorption: maximizing product recovery
✅ 100% integrity-tested filters before shipment
✅ High-standard manufacturing: ISO 9001 & GMP-compliant
✅ Comprehensive documentation: validation guide, CoQ, user manual
Technical Specifications (Highlights)
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Pore size: 0.22 μm / 0.45 + 0.22 μm
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Membrane material: Hydrophilic PES
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Support & housing: Polypropylene (PP)
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Sealing method: Thermal welding, no adhesives
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Max. forward pressure: 5 bar @ 20 °C
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Sterilization: Steam 134 °C × 30 min × 25 cycles / Gamma < 50 kGy
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Bacterial retention: > 10⁷ cfu/cm² B. diminuta (ATCC 19146)
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Endotoxin level: < 0.25 EU/ml (USP <85>)
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Manufacturing environment: Class 100,000 cleanroom
About Feature-Tec
Feature-Tec New Materials is a global filtration and separation solution provider integrating R&D, design, manufacturing, and validation.
With two production bases (Shanghai & Wuxi) and six offices worldwide, Feature-Tec has served industries for over 20 years, spanning semiconductors, automotive, food & beverage, biopharma, chemicals, water treatment, and clean energy.
Our CNAS-accredited Validation Center operates under CNAS/ISO 17025 and GMP-Like systems, ensuring full traceability and global quality compliance.
💡 Looking for the right filtration solution?
Our PES filtration experts are ready to design a custom solution for your process.
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Contact
Hotline: (+86)400-820-6150
Email: marketing@feature-tec.com
Address: 8/F, Block A, Building 3, Tianhua Information Technology Park, 299 Longcao Road, Xuhui District, Shanghai
