PES pleated filter cartridge
Cofilters PES cartridge filters help ensure reliable product processing in pharmaceutical applications.
- Polypropylene components and polyethersulphone (PES) membrane construction allow use in a broad range of applications
- Optimized form factor allows high flow and low pressure drop, lowering cost of ownership
- All components meet USP Class VI Plastics Test and USP Biological Reactivity Test, providing biocompatibility insurance and global regulatory compliance
APPLICATIONS
PES pleated filter cartridge
Pharmaceutical
- Bioburden reduction of LVP/SVP
- Sterile filtration for LVP/SVP/API
- Buffers
- Culture medium
- Intermediates
- Eye drops, antibiotics
Specifications
Drawings
| Length | Code 0 (A) | Code 5 (A) | Code 6 (A) | Code 7 (A) |
|---|---|---|---|---|
| 5" | 148.0 mm (5.8") | – | 150.5 mm (5.9") | – |
| 10" | 273.0 mm (10.7") | 314.0 mm (12.4") | 276.0 mm (10.9") | 316.5 mm (12.5") |
| 20" | 517.5 mm (20.4") | 558.5 mm (22.0") | 520.0 mm (20.5") | 561.0 mm (22.1") |
| 30" | 762.0 mm (30.0") | 803.0 mm (31.6") | 764.5 mm (30.1") | 805.5 mm (31.7") |
| 40" | 1006.5 mm (39.6") | 1047.5 mm (41.2") | 1009.0 mm (39.7") | 1050.0 mm (41.3") |
Performance Data
Specifications
Retention rating
- Single-layer
- Dual-layer
- 0.22, 0.45 µm
- 0.45/0.22 µm
Materials
- Membrane
- Support
- Sleeve, core, top, and end caps
- O-ring
- Sealing technology
- Polyethersulfone (PES)
- Polypropylene
- Polypropylene
- Silicone
- Thermal bonding without adhesives
Normal effective filtration area
- Single-layer
- Dual-layer
- 0.6 m2/10" cartridge
- 0.53 m2/10" cartridge
Integrity test (0.22μm,0.45/0.22μm)
- Minimum bubble point at 25°C (77°F)
- Maximum diffusion flow at 40.6 psi(2800 mbar) at 25°C (77°F)
- ≥50.7 psi (3500 mbar)
- 5" cartridge: ≤15 mL/min
- 10" cartridge ≤30 mL/min
Maximum operating conditions
- Maximum forward differential pressure
- Maximum operating temperature
- 60.9 psi (4.2 bar) @ 25°C (77°F), 29.0 psi (2.0 bar) @ 80°C (176°F)
- 80°C (176°F)
Multiple sterilization cycles
- 20 cycles of steam-in-place (SIP) sterilization or autoclave, 30 min at 127°C (261°F)
Endotoxin releasing
- <0.25 EU/mL as determined by the LAL test
TOC
- <0.5 mg/L after a water flush of 11 L/10" cartridge
Conductivity
- ≤1.3 µS/cm after water flush of 11 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)
Extractables
- Tested according to USP. Report is available upon request
Material toxicity
-
All components meet the requirements of the USP <88> Reactivity Test for Class VI Plastics
Filters meet the requirements of USP <87> Biological Reactivity Tests in Vitro Cytotoxicity
Bacterial challenge test
- Filters with the claim passed the bacterial challenge testing using Brevundimonas diminuta (ATCC 19146) at a minimum challenge concentration 1x107 CFU/cm2 (0.22 µm) per ASTM methodology.
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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Process fluid, filtration objectives, pore size rating, contaminant characteristics, operating temperature and pressure, flow rate, connection type, seal material, sterilization requirements, and existing cartridge specifications (if applicable).
