PTFE Membrane Coated Fiber Filter Element for Pharmaceutical Sector, 0.2 Micron, GMP Compliant Material
Product Spotlights
As a trusted manufacturer since 1998, Anping County Boli Hardware Wiremesh Products Factory introduces our PTFE Membrane Coated Fiber Filter Element designed specifically for the demanding pharmaceutical sector. With a precise 0.2 micron filtration rating and GMP compliant materials, this element ensures sterile filtration and particle removal critical for injectables, biopharmaceuticals, and cleanroom processes. Backed by over two decades of manufacturing expertise and an annual export value exceeding US$5 million, we deliver consistent quality to global markets including North America, Europe, and Asia.
Key Features & Technical Specifications
- High-Efficiency Filtration: 0.2 micron absolute rating meets USP <788> particulate standards for injectable solutions.
- PTFE Membrane Coating: Hydrophobic or hydrophilic options available for both liquid and gas sterilization.
- GMP Compliant Materials: All components – including media, support layers, and end caps – are manufactured in a controlled environment to avoid contamination.
- Broad Chemical Compatibility: Resistant to acids, alkalis, solvents, and oxidizing agents, making it suitable for aggressive pharmaceutical intermediates.
- High Flow Rates: Optimized pleated design minimizes pressure drop while maintaining throughput.
- Customizable Configurations: Available in lengths from 10 to 40 inches, with various end cap types (flat, fin, open) and sealing options (O-ring, thermal bond).
| Parameter | Specification |
|---|---|
| Filtration Rating | 0.2 μm (absolute) |
| Media | PTFE membrane on non-woven polyester support |
| Maximum Operating Temperature | 80°C (176°F) continuous |
| Maximum Differential Pressure | 4.0 bar (58 psi) at 25°C |
| Effective Filtration Area | 0.6 – 0.8 m² per 10-inch element |
| Integrity Test | 100% bubble point tested per ASTM F838 |
Our filter elements are manufactured under strict quality control procedures, ensuring each unit meets the pharmaceutical industry's requirements for low extractables and non-fiber releasing performance. The PTFE membrane coating provides a smooth, hydrophobic surface that resists protein binding and biofilm formation, extending service life and reducing replacement costs.
Benefits for Your Pharmaceutical Process
- Sterile Assurance: 0.2 micron absolute retention eliminates bacteria and fungi, compliant with HIMA and ASTM standards.
- Reduced Validation Effort: GMP compliant materials and documented manufacturing process simplify regulatory submissions.
- Cost Efficiency: High dirt-holding capacity and thermal stability allow repeated steam sterilization (up to 140°C) without compromising integrity.
- Supply Reliability: As a factory-direct manufacturer with over 20 years in business, we maintain stable inventory and fast lead times from our Hebei, China facility.
Trust & Global Acceptance
Anping County Boli Hardware Wiremesh Products Factory has been providing filtration solutions to pharmaceutical companies worldwide since 1998. Our annual export value of US$5 million–US$10 million reflects the trust placed in our products by clients in North America, South America, Europe, Southeast Asia, and Africa. We ship from major ports including Tianjin, Qingdao, Shanghai, and Foshan, ensuring efficient logistics. Each filter element is individually packaged and tagged with lot number for full traceability. Contact us today to request samples, technical datasheets, or discuss custom configurations for your specific application.
FAQ – Frequently Asked Questions
-
Q: Is this filter element suitable for sterile filtration of biologics?
A: Yes, the 0.2 micron PTFE membrane meets the requirements for sterilizing-grade filtration of aqueous solutions, including heat-sensitive biologics. The membrane is available in both hydrophobic and hydrophilic forms. -
Q: Can the element be steam sterilized in place (SIP)?
A: Yes, the construction supports up to 140°C steam sterilization cycles. However, we recommend consulting our technical team for specific cycle parameters to maximize element life. -
Q: What certifications or documentation do you provide?
A: We provide a certificate of compliance based on GMP manufacturing. Additional documentation such as material traceability, validation guides, and extractables data are available upon request. -
Q: How do I select the correct end cap and sealing option?
A: Our standard configurations include flat, fin, and open end caps. O-ring or thermal bond seals are available. Please refer to our filter housing compatibility chart or contact us for personalized recommendation. -
Q: What is the minimum order quantity?
A: We offer flexible MOQs – typically 20 pieces for standard sizes, and lower quantities for sample orders. Custom lengths may require higher minimums. -
Q: Can you provide a sample for testing before bulk purchase?
A: Yes, sample orders are welcome. We can ship a few units for evaluation. Please note that sample logistics and cost are subject to your location and shipping method. -
Q: How long is the typical lead time?
A: For standard sizes and configurations, lead time is 15–25 working days after order confirmation. Custom orders may take 30–40 days depending on complexity. -
Q: Is the filter element FDA or USP Class VI compliant?
A: While our materials are GMP compliant and designed for pharmaceutical use, we can provide biocompatibility testing data (e.g., USP , ) upon request. Please inquire for specific regulatory needs.
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