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Help CenterPrecision Filtration Unit for Pharmaceutical Sterile Filtration 0.22μm Membrane
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Anping County Boli Hardware Wiremesh Products Factory, established in 1998, is a professional manufacturer specializing in precision filtration solutions. Our Precision Filtration Unit for Pharmaceutical Sterile Filtration 0.22μm Membrane is designed to meet the rigorous demands of the pharmaceutical industry, ensuring reliable removal of bacteria, particles, and microorganisms. With over 20 years of manufacturing experience and annual export value between US$5 million and US$10 million, we deliver high-quality products that are trusted by clients across North America, Europe, Southeast Asia, and beyond.
This filtration unit utilizes a 0.22 micron membrane to achieve sterile filtration, complying with pharmacopoeia requirements for critical applications. The housing is constructed from 316L stainless steel, offering excellent corrosion resistance and durability, while the membrane material (PVDF or PES) is selected for low protein binding and high flow rates. The unit is designed for easy installation, operation, and maintenance, with options for customization to fit specific system requirements.
Key Features & Technical Specifications:
- High Precision Filtration: 0.22 μm absolute pore size ensures removal of >99.99% of bacteria and particulates, meeting sterile filtration standards.
- Material Options: Membrane available in PVDF (hydrophobic/hydrophilic) or PES (low protein binding) – customizable based on your application.
- Robust Housing: 316L stainless steel with electropolished surface finish, designed for CIP/SIP (clean-in-place/steam-in-place) cycles.
- Versatile Connections: Inlet/outlet options include Tri-clamp, NPT, or flanged connections (1/4” to 2”) to integrate with existing piping.
- High Flow Capacity: Filtration area ranges from 0.5 m² to 5 m², allowing scalability for batch or continuous processes.
- Operating Conditions: Maximum pressure 4.0 bar at 25°C; maximum temperature 80°C (higher temperature options available upon request).
- Integrity Testing: Unit supports in-place bubble point or diffusion testing for validation.
| Parameter | Value |
|---|---|
| Membrane Pore Size | 0.22 μm |
| Filtration Area | 0.5 – 5 m² (customizable) |
| Housing Material | SS 316L (electropolished) |
| Max Operating Pressure | 4.0 bar @ 25°C |
| Max Operating Temperature | 80°C (higher on request) |
| Connections | Tri-clamp, NPT, Flange (1/4”–2”) |
| Sterilization | Autoclavable 121°C / 30 min |
Benefits for Your Pharmaceutical Process:
- Enhanced Product Safety: Reliable removal of microorganisms ensures compliance with sterility assurance levels (SAL).
- Lower Operating Costs: High dirt-holding capacity and long service life reduce replacement frequency.
- Easy Scale-Up: Modular design with multiple filtration area options supports both lab-scale and production-scale needs.
- Full Validation Support: We provide documentation including material certificates, integrity test data, and extractables guidance.
Trust & Experience: As a manufacturer with over 25 years of history, we have supplied filtration units to pharmaceutical companies worldwide. Our annual export revenue of US$5-10 million reflects our commitment to quality and customer satisfaction. We ship from major Chinese ports (Tianjin, Qingdao, Shanghai, Foshan) with fast lead times. Our products are used in diverse markets including North America, Europe, Southeast Asia, Africa, and Oceania. We welcome inquiries for custom specifications and OEM orders.
Choose Anping County Boli Hardware Wiremesh Products Factory for your sterile filtration needs – experience precision engineering, competitive pricing, and dedicated support. Contact us today for a quote or technical consultation.
Frequently Asked Questions (FAQ)
Q1: What membrane materials are available for this filtration unit?
A: We offer PVDF (hydrophobic or hydrophilic) and PES (polyethersulfone) membranes. PVDF is ideal for solvent-containing or gas filtration, while PES provides low protein binding for biological solutions. Both are suitable for sterile filtration.
Q2: Can the unit be sterilized by steam or autoclave?
A: Yes. The 316L stainless steel housing and PVDF/PES membranes can withstand autoclaving at 121°C for 30 minutes. For in-line steam sterilization (SIP), please specify your requirements – we can provide adapted designs.
Q3: How do I validate the integrity of the filter?
A: The unit supports bubble point testing and diffusion testing. We can provide a test port and procedure documentation. Our quality team can also assist with validation protocols.
Q4: What is the typical lifespan of the membrane?
A: Lifespan depends on the fluid type, particulate load, and cleaning frequency. Under normal pharmaceutical water filtration conditions, membranes can last for several months. Periodic integrity testing is recommended to determine replacement intervals.
Q5: Can I get custom connection sizes or housing dimensions?
A: Absolutely. We customize filtration area, connection types, and housing length to match your equipment. Custom options are available at competitive pricing. Please provide your drawings or specifications.
Q6: Is this unit suitable for both lab-scale and production-scale processes?
A: Yes. We offer a range of filtration areas from 0.5 m² (lab/pilot) to 5 m² (production). For larger needs, multiple units can be paralleled or we can design larger systems on request.
Q7: Do you provide certificates of compliance or material traceability?
A: Yes. We can provide material certificates (3.1), membrane integrity test reports, and a certificate of conformance. Additional documentation is available upon request.
Q8: What are the shipping options and lead time?
A: We ship from Tianjin, Qingdao, Shanghai, or Foshan ports. Standard lead time is 15-25 working days, depending on customization. Express shipping is available for urgent orders.
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