Pharmsteri APFS PES Liquid Cartridge Filter
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- Process intermediates in mAb, vaccines, etc.
- Bulk drug substances
- Protein solutions or formulations
- Other fouling fluids
Specifications
| Size | Code 6 Dimension A | Code 7 Dimension A | ||
| 5" | 150.5 mm (5.9”) | 199.0 mm (7.8”) | ||
| 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”) | ||
| Materials | Media | Asymmetric Polyethersulfone | ||
| Support | Polypropylene | |||
| Core, cage, end caps | Polypropylene | |||
| O-ring | Silicone | |||
| Sealing technology | Thermal bonding without adhesives | |||
| Retention rating | 0.45 μm, 0.65 μm | |||
| Filtration area | 5" | 0.3 m2 | ||
| Per 10" | 0.6 m2 | |||
| Integrity | Minimum bubble point@ 25°C (77°F) | 0.45 μm | ≥2.3 bar (33.3 psi) air with water | |
| 0.65 μm | ≥1.3 bar (18.8psi) air with water | |||
| Maximum water diffusion flow @ 25°C (77°F) | 0.45 μm, 5" | ≤ 11 mL/min @ 1500 mbar (21.7 psi) | ||
| 0.45 μm, Per 10" | ≤ 20 mL/min @ 1500 mbar (21.7 psi) | |||
| 0.65 μm, 5" | ≤ 8 mL/min @ 600 mbar (8.7 psi) | |||
| 0.65 μm, Per 10" | ≤ 15 mL/min @ 600 mbar (8.7 psi) | |||
| Maximum operating conditions | Maximum forward differential pressure | 61 psi (4.2 bar) @ 25°C (77°F) | ||
| 29 psi (2.0 bar) @ 80°C | ||||
| Maximum operating temperature | 80°C (176°F) | |||
| Multiple sterilization cycles | 25 cycles of autoclave, 30 min at 127°C (260.6°F), or 25 cycles of 30 min steam in place (SIP) at 131°C with differential pressure under 300 mbar | |||
| Endotoxin releasing | <0.25 EU/mL as determined by the LAL test, meeting the requirements of USP <85> | |||
| Particulates | Particulate matter release meets the requirement of USP <788> | |||
| Non-fiber releasing | Manufactured with non-fiber release materials and tested according to 21 CFR 210.3 (b) (6) | |||
| TOC | <0.5 mg/L post gamma and after a water flush, meeting the requirements of USP <643> | |||
| Conductivity | ≤1.3 µS/cm post gamma and after water flush, meeting the requirements of USP <645> | |||
| Material toxicity | All components meet the requirements of the USP <87>, Biological Reactivity Test and the USP <88> Reactivity Test for Class VI Plastics | |||
| Animal Free | Raw materials used to manufacture this product are not animal derived, meeting the EU directive for animal free CPMP EMA/410/01 and 21 CFR parts 189.5 | |||
| Extractables | Tested according to BioPhorum Operations Group (BPOG) guideline. Report is available upon request. | |||
| Quality | 100% integrity tested, manufactured in accordance with ISO 9001 and ISO 13485 certified quality management system | |||
Successfully Opted for software Updates
| Part Number | Retention Rating | Connection | Length | O-ring | Packaging Configuration |
|---|---|---|---|---|---|
| PSTSA045605S1 | 0.45 µm | Code 6 | 5" | Silicone | 1 ea/box |
| PSTSA045610S1 | 0.45 µm | Code 6 | 10" | Silicone | 1 ea/box |
| PSTSA045620S1 | 0.45 µm | Code 6 | 20" | Silicone | 1 ea/box |
| PSTSA045630S1 | 0.45 µm | Code 6 | 30" | Silicone | 1 ea/box |
| PSTSA045705S1 | 0.45 µm | Code 7 | 5" | Silicone | 1 ea/box |
| PSTSA045710S1 | 0.45 µm | Code 7 | 10" | Silicone | 1 ea/box |
| PSTSA045720S1 | 0.45 µm | Code 7 | 20" | Silicone | 1 ea/box |
| PSTSA045730S1 | 0.45 µm | Code 7 | 30" | Silicone | 1 ea/box |
| PSTSA065605S1 | 0.65 µm | Code 6 | 5" | Silicone | 1 ea/box |
| PSTSA065610S1 | 0.65 µm | Code 6 | 10" | Silicone | 1 ea/box |
| PSTSA065620S1 | 0.65 µm | Code 6 | 20" | Silicone | 1 ea/box |
| PSTSA065630S1 | 0.65 µm | Code 6 | 30" | Silicone | 1 ea/box |
| PSTSA065705S1 | 0.65 µm | Code 7 | 5" | Silicone | 1 ea/box |
| PSTSA065710S1 | 0.65 µm | Code 7 | 10" | Silicone | 1 ea/box |
| PSTSA065720S1 | 0.65 µm | Code 7 | 20" | Silicone | 1 ea/box |
| PSTSA065730S1 | 0.65 µm | Code 7 | 30" | Silicone | 1 ea/box |