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Pharmsteri™ PTFE CARTRIDGE FILTER
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Pharmsteri™ PTFE Cartridge Filter
Product Introduction
The Pharmsteri™ PTFE Cartridge Filter is a high-performance sterile gas filter that features a hydrophobic PTFE membrane and a polypropylene structure, designed to deliver excellent filtration efficiency and biological safety in pharmaceutical and food applications. This product meets strict quality and safety standards, making it ideal for sterile gas filtration and venting processes.
Technical Specifications
Dimensions and Connections
Length | Code 6 (A) | Code 7 (A) |
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5″ | 150.5 mm | – |
10″ | 276.0 mm | 316.5 mm |
20″ | 520.0 mm | 561.0 mm |
30″ | 764.5 mm | 805.5 mm |
Performance Characteristics
Parameter | Value |
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Filtration rating | 0.22 µm |
Effective filtration area | ≥0.58 m² (10″), ≥0.28 m² (5″) |
Membrane material | Polytetrafluoroethylene (PTFE) |
Support material | Polypropylene |
O-ring material | Silicone |
Bonding method | Thermal bonding without adhesives |
Maximum differential pressure | 4.2 bar @ 25°C; 2.0 bar @ 80°C |
Sterilization cycles | 100 SIP cycles (135°C, 30 minutes) or 50 reverse SIP cycles (127°C, 30 minutes), or 100 autoclave cycles (127°C, 30 minutes) |
Endotoxin release | <0.25 EU/mL (based on LAL test) |
TOC after flushing | <0.5 mg/L after flushing 5 L of water per 10″ cartridge |
Conductivity after flushing | ≤1.3 µS/cm after flushing 5 L of water per 10″ cartridge |
Particle release | Meets WFI requirements per USP |
Material toxicity | Complies with USP <88> Class VI and USP <87> |
Bacterial retention | Meets ASTM F838 with Brevundimonas diminuta (ATCC 19146) |
Compliance | FDA 21 CFR 177–182, EU No. 1935/2004, EU No. 10/2011, ISO 9001, ISO 13485 |
Key Features
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High sterile filtration performance: Certified to ASTM F838, effectively removes bacteria and microbial particles in gases.
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Optimized design: Adhesive-free thermal bonding structure minimizes contamination risk and enhances durability.
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Sterilization durability: Withstands multiple steam or autoclave sterilization cycles without performance degradation.
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International compliance: Meets stringent global standards for biocompatibility and material safety.
User Benefits
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Product safety assurance: Effectively eliminates bacteria and microbial contaminants in gases, safeguarding final product quality.
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Lower operating costs: Optimized design reduces pressure drop, conserves energy, and extends equipment life.
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Easy integration: Compatible with various systems and applications in pharmaceutical and food industries.
Applications
Pharmsteri™ PTFE Cartridge Filter is widely used in:
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Sterile gas filtration: In pharmaceutical and food manufacturing processes.
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Sterile venting: For storage tanks, CIP/SIP systems, and fermentation equipment.
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Compressed air filtration: Ensures clean and sterile compressed air for sensitive applications.
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