PTFE pleated filter cartridge
Provides safe, sterile filtration for air and gas applications in pharmaceutical and food & beverage industries.
- Polypropylene components and hydrophobic polytetrafluoroethylene (PTFE) membrane construction allow use in a range of air and gas applications
- Sterilizing-grade meets Bacterial Challenge Test ASTM F838, providing safe, sterile filtration
- All components meet USP Class VI Plastics Test, providing biosafety insurance and global regulatory compliance
- 100% integrity tested before release provides high-quality, sterility assurance
APPLICATIONS
PTFE pleated filter cartridge application
- Sterile filtration for air and gas
- Vent filtration
Specifications
Drawings
| Length | Code 6 (A) | Code 7 (A) |
|---|---|---|
| 5" | 150.5 mm (5.9") | – |
| 10" | 276.0 mm (10.9") | 316.5 mm (12.5") |
| 20" | 520.0 mm (20.5") | 561.0 mm (22.1") |
| 30" | 764.5 mm (30.1") | 805.5 mm (31.7") |
| 40" | 1009.0 mm (39.7") | 1050.0 mm (41.3") |
Specifications
Retention rating
- Single-layer
- 0.22 µm
Materials
- Media
- Support
- Sleeve, core, top, and end caps
- O-ring
- Sealing technology
- Polytetrafluoroethylene (PTFE)
- Polypropylene
- Polypropylene
- Silicone
- Thermal bonding without adhesives
Filtration area
- ≥0.58 m2 @ 10", ≥0.28 m2 @ 5"
Normal effective filtration area
- Single-layer
- Dual-layer
- 0.6 m2/10" cartridge
- 0.53 m2/10" cartridge
Integrity test (0.22μm)
- Minimum bubble point at 60% isopropanol water, 25°C (77°F)
- Minimum bubble point at 95% ethanol water, 25°C (77°F)
- Water intrusion at 2620 mbar @ 25°C (77°F)
- ≥1155 mbar
- ≥1100 mbar
- ≤1.0 mL/min @ 5"
- ≤1.4 mL/min @ 10"
Maximum operating conditions
- Maximum forward differential pressure
- 4.2 bar @ 25°C (77°F), 2.0 bar @ 80°C (176°F)
Maximum operating conditions
- 20 cycles of steam-in-place (SIP) sterilization or autoclave, 30 min at 127°C (261°F)
Sterilization cycles
- Maintained integrity after 100 cycles of forward steam-in-place (SIP) sterilization at 135°C (275°F) for 30 min, or 50 cycles of reverse SIP sterilization at 127°C (261°F) for 30 min,or 100 cycles of autoclave at 127°C (261°F) for 30 min
Endotoxin releasing
- <0.25 EU/mL according to the test methodology in USP
TOC
- <0.5 mg/L after a water flush of 5 L/10" cartridge
Conductivity
- ≤1.3 µS/cm after water flush of 5 L/10" cartridge
Particle release
- Meets the requirements of WFI set by USP
Non-fiber releasing
- Meets the criteria for a non-fiber releasing filter defined in 21 CFR 210.3(b)(6)
NVR
- After autoclaving and 24-hours in 50% ethanol water with vibration (contact Entegris for details)
Material toxicity
- All components meet the requirements of the USP Reactivity Test for Class VI Plastics
- Filters meet the requirements of USP Biological Reactivity Tests In Vitro Cytotoxicity
Bacterial challenge test
- Passed the bacterial challenge test using Brevundimonas diminuta (ATCC 19146) at a minimum challenge concentration 1x107 CFU/cm2 (0.22 µm) per ASTM F838
Indirect food additive
- Meets the FDA Indirect Food Additive requirements cited in 21 CFR 177-182
Food contact material
- (EU) No. 1935/2004, (EU) No. 10/2011
Quality
- Manufactured in accordance with ISO 9001 and ISO 13485 certified quality management system
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