Pharmsteri™ PES Disposable Filter
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Applications
- Bioburden reduction or sterile filtration for injections
- Bulk chemicals
- Buffers
Specifications
| Retention rating | 0.22, 0.45 µm | |
| Materials | Membrane | Polyethersulfone (PES) |
| Housing, support | Polypropylene | |
| Sleeve, core, top, end caps | Polypropylene | |
| O-ring | Silicone | |
| Sealing technology | Thermal bonding without adhesives | |
| Filtration area | 10" | ≥0.6 m2 |
| 5" | ≥0.3 m2 | |
| Integrity test (0.22 µm) | Minimum bubble point at 25°C (77°F) | ≥3500 mbar |
| Maximum diffusion flow at 2800 mbar @ 25°C (77°F) | 5": ≤15 mL/min | |
| 10": ≤30 mL/min | ||
| Maximum operating conditions | Maximum forward differential pressure | 3.5 bar @ 25° ±2°C (77°F), 3.0 bar @ 60° ±2°C (140°F) |
| Sterilization cycles | Maximum 5 cycles of autoclave @ 127°C (261°F), 30 min | |
| Endotoxin releasing | <0.25 EU/mL according to the USP test methodology | |
| TOC | <0.5 mg/L after a water flush of 11 L/10" filter | |
| Conductivity | ≤1.3 µS/cm after water flush of 11 L/10" filter | |
| Particle release | Meets the requirements of WFI set by USP | |
| 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 <88> Reactivity Test for Class VI Plastics | |
| 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 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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Part Numbers
| Part Number | Retention Rating | Length |
|---|---|---|
| PSTSUS022FS05-A2 | 0.22 µm | 5" |
| PSTSUS022FS10-A2 | 0.22 µm | 10" |
| PSTSUS045FS05-A2 | 0.45 µm | 5" |
| PSTSUS045FS10-A2 | 0.45 µm | 10" |