Pharmsteri™ PTFE Cartridge Filter
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Applications
- Sterile filtration for air and gas
- Vent filtration
Specifications
| 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") |
| Retention rating | 0.22 µm | |
| Materials | Media | Polytetrafluoroethylene (PTFE) |
| Support | Polypropylene | |
| Sleeve, core, top, and end caps | Polypropylene | |
| O-ring | Silicone | |
| Sealing technology | Thermal bonding without adhesives | |
| Filtration area | ≥0.58 m2 @ 10", ≥0.28 m2 @ 5" | |
| Integrity test | Minimum bubble point at 60% isopropanol water, 25°C (77°F) | ≥1155 mbar |
| Minimum bubble point at 95% ethanol water, 25°C (77°F) | ≥1100 mbar | |
| Water intrusion at 2620 mbar @ 25°C (77°F) | ≤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) |
| Sterilization cycles | Maintained integrity after 25 cycles of steam-in-place (SIP) sterilization (forward and reverse) or autoclave, 30 min at 127°C (261°F) | |
| 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 <88> Reactivity Test for Class VI Plastics | |
| Filters meet the requirements of USP <87> 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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Part Numbers
| Part Number | Connection | Length | O-ring | Retention Rating |
|---|---|---|---|---|
| PSTT022605S1 | Code 6 | 5" | Silicone | 0.22 µm |
| PSTT022610S1 | Code 6 | 10" | Silicone | 0.22 µm |
| PSTT022620S1 | Code 6 | 20" | Silicone | 0.22 µm |
| PSTT022630S1 | Code 6 | 30" | Silicone | 0.22 µm |
| PSTT022710S1 | Code 7 | 10" | Silicone | 0.22 µm |
| PSTT022720S1 | Code 7 | 20" | Silicone | 0.22 µm |
| PSTT022730S1 | Code 7 | 30" | Silicone | 0.22 µm |