Pharmsteri™ PES Cartridge Filter
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Reference Materials
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Applications
Pharmaceutical
- Bioburden reduction of LVP/SVP
- Sterile filtration for LVP/SVP/API
- Buffers
- Culture medium
- Intermediates
Specifications
| 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") |
| Retention rating | Single-layer | 0.22, 0.45 µm |
| Dual-layer | 0.45/0.22 µm | |
| Materials | Membrane | Polyethersulfone (PES) |
| Support | Polypropylene | |
| Sleeve, core, top, and end caps | Polypropylene | |
| O-ring | Silicone | |
| Sealing technology | Thermal bonding without adhesives | |
| Normal effective filtration area | Single-layer | 0.6 m2/10" cartridge |
| Dual-layer | 0.53 m2/10" cartridge | |
| Integrity test (0.22μm,0.45/0.22μm) |
Minimum bubble point at 25°C (77°F) | ≥50.7 psi (3500 mbar) |
| Maximum diffusion flow at 40.6 psi(2800 mbar) at 25°C (77°F) | 5" cartridge: ≤15 mL/min | |
| 10" cartridge ≤30 mL/min | ||
| Maximum operating conditions | Maximum forward differential pressure | 60.9 psi (4.2 bar) @ 25°C (77°F), 29.0 psi (2.0 bar) @ 80°C (176°F) |
| Maximum operating temperature | 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<665>. 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 | |
Successfully Opted for software Updates
Part Numbers
| Part Number | Connection | Length | O-ring | Retention Rating |
|---|---|---|---|---|
| PSTS022005S1 | Code 0 | 5" | Silicone | 0.22 µm |
| PSTS022010S1 | Code 0 | 10" | Silicone | 0.22 µm |
| PSTS022020S1 | Code 0 | 20" | Silicone | 0.22 µm |
| PSTS022030S1 | Code 0 | 30" | Silicone | 0.22 µm |
| PSTS022040S1 | Code 0 | 40" | Silicone | 0.22 µm |
| PSTS022510S1 | Code 5 | 10" | Silicone | 0.22 µm |
| PSTS022520S1 | Code 5 | 20" | Silicone | 0.22 µm |
| PSTS022530S1 | Code 5 | 30" | Silicone | 0.22 µm |
| PSTS022540S1 | Code 5 | 40" | Silicone | 0.22 µm |
| PSTS022605S1 | Code 6 | 5" | Silicone | 0.22 µm |
| PSTS022610S1 | Code 6 | 10" | Silicone | 0.22 µm |
| PSTS022620S1 | Code 6 | 20" | Silicone | 0.22 µm |
| PSTS022630S1 | Code 6 | 30" | Silicone | 0.22 µm |
| PSTS022640S1 | Code 6 | 40" | Silicone | 0.22 µm |
| PSTS022710S1 | Code 7 | 10" | Silicone | 0.22 µm |
| PSTS022720S1 | Code 7 | 20" | Silicone | 0.22 µm |
| PSTS022730S1 | Code 7 | 30" | Silicone | 0.22 µm |
| PSTS022740S1 | Code 7 | 40" | Silicone | 0.22 µm |
| PSTS045005S1 | Code 0 | 5" | Silicone | 0.45 µm |
| PSTS045010S1 | Code 0 | 10" | Silicone | 0.45 µm |
| PSTS045020S1 | Code 0 | 20" | Silicone | 0.45 µm |
| PSTS045030S1 | Code 0 | 30" | Silicone | 0.45 µm |
| PSTS045040S1 | Code 0 | 40" | Silicone | 0.45 µm |
| PSTS045510S1 | Code 5 | 10" | Silicone | 0.45 µm |
| PSTS045520S1 | Code 5 | 20" | Silicone | 0.45 µm |
| PSTS045530S1 | Code 5 | 30" | Silicone | 0.45 µm |
| PSTS045540S1 | Code 5 | 40" | Silicone | 0.45 µm |
| PSTS045605S1 | Code 6 | 5" | Silicone | 0.45 µm |
| PSTS045610S1 | Code 6 | 10" | Silicone | 0.45 µm |
| PSTS045620S1 | Code 6 | 20" | Silicone | 0.45 µm |
| PSTS045630S1 | Code 6 | 30" | Silicone | 0.45 µm |
| PSTS045640S1 | Code 6 | 40" | Silicone | 0.45 µm |
| PSTS045710S1 | Code 7 | 10" | Silicone | 0.45 µm |
| PSTS045720S1 | Code 7 | 20" | Silicone | 0.45 µm |
| PSTS045730S1 | Code 7 | 30" | Silicone | 0.45 µm |
| PSTS045740S1 | Code 7 | 40" | Silicone | 0.45 µm |
| PSTSD42605S1 | Code 6 | 5" | Silicone | 0.45 + 0.22 µm |
| PSTSD42710S1 | Code 7 | 10" | Silicone | 0.45 + 0.22 µm |
| PSTSD42720S1 | Code 7 | 20" | Silicone | 0.45 + 0.22 µm |
| PSTSD42730S1 | Code 7 | 30" | Silicone | 0.45 + 0.22 µm |