Pharmsteri™ II GHF 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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Reference Materials
CAD
CAD drawings may be available for this product. Please use the Part Selector to select a part number to see if they are available.
Applications
- Buffers
- Chemical solutions
- Small molecule preparations
- Chemical drugs formulations
- Cleaning and sanitization solutions
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 (PES) | Polyethersulfone (PES) | |
| Support | Polyester | Polyester | ||
| Film edge | Polypropylene/polyethylene copolymer | |||
| Core, cage, end caps | Polypropylene | Polypropylene | ||
| O-ring | Silicone | Silicone | ||
| Sealing technology | Mechanical fsealing with O-ring | Thermal bonding without adhesives | ||
| Pore size | 0.22 µm | 0.22 µm | ||
| Filtration area | 17.3 cm2 | 3" | 0.19 m2 | |
| 5" | 0.36 m2 | |||
| 10" | 0.72 m2 | |||
| Integrity | Bubble point | - | ≥3.65 bar (53 psi) air with water | |
| Water Diffusion | - | 3" | ≤6.5 mL/min @ 40 psi at 25°C (77°F) | |
| 5" | ≤13.0 mL/min @ 40 psi at 25°C (77°F) | |||
| 10" | ≤25.0 mL/min @ 40 psi at 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. | ||||
Successfully Opted for software Updates
Published Nov 2, 2022
Manual and Guide
Pharmsteri™ II PES 0.22 Buffer Capsule Filters Validation Guide
1.6 MB
Part Numbers
| Part Number | Inlet and Outlet Connection | Vent and Drain Connection | Size | Packaging Configuration |
|---|---|---|---|---|
| PSTSUSA022HS032 | 1/2" hose barb | 1/8" hose barb | 3" capsule | Two per box |
| PSTSUSA022HS051 | 1/2" hose barb | 1/8" hose barb | 5" capsule | One per box |
| PSTSUSA022HS101 | 1/2" hose barb | 1/8" hose barb | 10" capsule | One per box |
| PSTSUSA022SH003 | 1/4” stepped hose barb | Luer male with cap | 50 mm disc | Three per box |
| PSTSUSA022TH032 | 1.5" sanitary TC inlet and 1/2" hose barb outlet | 1/8" hose barb | 3" capsule | Two per box |
| PSTSUSA022TH051 | 1.5" sanitary TC inlet and 1/2" hose barb outlet | 1/8" hose barb | 5" capsule | One per box |
| PSTSUSA022TH101 | 1.5" sanitary TC inlet and 1/2" hose barb outlet | 1/8" hose barb | 10" capsule | One per box |
| PSTSUSA022TS032 | 1.5" sanitary TC | 1/8" hose barb | 3" capsule | Two per box |
| PSTSUSA022TS051 | 1.5" sanitary TC | 1/8" hose barb | 5" capsule | One per box |
| PSTSUSA022TS101 | 1.5" sanitary TC | 1/8" hose barb | 10" capsule | One per box |
Note: Pre-sterilized capsules by Gamma irradiation available, refer to part number matrix for corresponding part number or check with Entegris specialist.