Pharmsteri™ II GHC PES Liquid Capsule Filter
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Note: Pre-sterilized capsules by Gamma irradiation available, refer to part number matrix for corresponding part number or check with Entegris specialist.
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Applications
- Bioburden or sterile filtration for various process fluids
- Cell culture media and additives
- Process intermediates in mAb, vaccines, etc.
- Column or downstream unit protection
- High concentration buffers
- Bulk drug substances
- Protein solutions or formulations
- Other high fouling fluids
Specifications
| Size - Connections | Total Length - A | Body Diameter - B | Min Width - C | Max Width - D |
| 3-inch TC-TC | 154.5 mm (6.08”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 3-inch TC-HB | 156.7 mm (6.17”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 3-inch HB-HB | 159.7 mm (6.29”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 5-inch TC-TC | 213.2 mm (8.39”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 5-inch TC-HB | 216.5 mm (8.52”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 5-inch HB-HB | 219.5 mm (8.96”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 10-inch TC-TC | 335.5 mm (13.21”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 10-inch TC-HB | 339.0 mm (13.35”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 10-inch HB-HB | 342.0 mm (13.46”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 50mm Disc | 3"/5"/10" In-Line Capsules | ||||||
| Materials | Media | Polyethersulfone | Polyethersulfone | ||||
| Support | Polypropylene | Polypropylene | |||||
| Core, cage, end caps | Polypropylene | Polypropylene | |||||
| O-ring | Silicone | Silicone | |||||
| Sealing technology | Mechanical sealing with O-ring | Thermal bonding without adhesives | |||||
| Pore size | 0.45+0.22 µm | 0.45+0.22 µm | |||||
| Filtration area | 17.3 cm2 | 3" | 0.16 m2 | ||||
| 5" | 0.30 m2 | ||||||
| 10" | 0.60m2 | ||||||
| Integrity | Bubble point | ≥3.65 bar (53 psi) air with water | |||||
| Water Diffusion | 3" | ≤ 6.8 mL/min @ 40psi @ 25°C (77°F) | |||||
| 5" | ≤ 11 mL/min @ 40psi @ 25°C (77°F) | ||||||
| 10" | ≤ 20.5 mL/min @ 40psi @ 25°C (77°F) | ||||||
| Maximum operating conditions | Maximum operating pressure | 80 psi (5.5 bar) @ 25°C (77°F) | 80 psi (5.5 bar) @ 25°C (77°F) | ||||
| 40 psi (2.8 bar) @ 60°C (140°F) | 40 psi (2.8 bar) @ 60°C (140°F) | ||||||
| Maximum differential pressure | Forward 60 psi (4.1 bar) @ 25°C (77°F) | Forward 60 psi (4.1 bar) @ 25°C (77°F) | |||||
| Forward 30 psi (2.1 bar) @ 60°C (140°F) | Forward 30 psi (2.1 bar) @ 60° C (140° F) | ||||||
| Reverse 10 psi (0.7 bar) @ 25°C (77°F) | Reverse 10 psi (0.7 bar) @ 25°C (77°F) | ||||||
| Bacteria Retention | Sterilizing grade membrane | >107 CFU/cm2 B. diminuta per the ASTM F838. | |||||
| Multiple sterilization Cycles | 2 cycles of autoclave, 30 min at 130°C (266°F) | ||||||
| Gamma stability | Gamma irradiation stable up to 45 kGy | ||||||
| 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 | ||||||
| *Test post-gamma irradiation. Refer to our validation guide for details. | |||||||
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Part Numbers
| Part Number | Size | Inlet and Outlet Connection | Packaging Configuration | Vent and Drain Connection |
|---|---|---|---|---|
| PSTSUSD042HS032 | 3" capsule | 1/2" hose barb | Two per box | 1/8" hose barb |
| PSTSUSD042HS051 | 5" capsule | 1/2" hose barb | One per box | 1/8" hose barb |
| PSTSUSD042HS101 | 10" capsule | 1/2" hose barb | One per box | 1/8" hose barb |
| PSTSUSD042SH003 | 50 mm disc | 1/4” stepped hose barb | Three per box | Luer male with cap |
| PSTSUSD042TH032 | 3" capsule | 1.5" sanitary TC inlet and 1/2" hose barb outlet | Two per box | 1/8" hose barb |
| PSTSUSD042TH051 | 5" capsule | 1.5" sanitary TC inlet and 1/2" hose barb outlet | One per box | 1/8" hose barb |
| PSTSUSD042TH101 | 10" capsule | 1.5" sanitary TC inlet and 1/2" hose barb outlet | One per box | 1/8" hose barb |
| PSTSUSD042TS032 | 3" capsule | 1.5" sanitary TC | Two per box | 1/8" hose barb |
| PSTSUSD042TS051 | 5" capsule | 1.5" sanitary TC | One per box | 1/8" hose barb |
| PSTSUSD042TS101 | 10" capsule | 1.5" sanitary TC | One per box | 1/8" hose barb |
Note: Pre-sterilized capsules by Gamma irradiation available, refer to part number matrix for corresponding part number or check with Entegris specialist.