Pharmsteri™ II GSV UPE Vent 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 your Entegris specialist. Entegris and MKS have developed compatible capsule heating jackets, available directly from MKS. Check with you Entegris specialist for more information, or visit the MKS website for Series 48 Heaters.
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Reference Materials
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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
- Single use bioreactor vessels or bags
- Mixer vessels or bags
- Storage or holding vessels or bags
- Filling tube sets or bag assemblies
- Carboys or Bottles assemblies
- Filtration or transfer assemblies
- Integrity test manifolds
- Single use cell therapy devices or assemblies
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 Capsule | ||||||
| Materials | Media | UPE | UPE | ||||
| Support | Polyethylene | Polyethylene | |||||
| Core, cage, end caps | Polypropylene | Polypropylene | |||||
| O-ring | Silicone | Silicone | |||||
| Sealing technology | Thermal and ultrasonic bonding | Thermal bonding without adhesives | |||||
| Pore size | 0.22 µm | 0.22 µm | |||||
| Filtration area | 19.6 cm2 | 3": | 0.18 m2 | ||||
| 5" | 0.33 m2 | ||||||
| 10" | 0.65 m2 | ||||||
| Integrity | Bubble Point | ≥1.45 bar (21 psi) 60% IPA with water | ≥1.45 bar (21 psi) 60% IPA with water | ||||
| Maximum operating conditions | Maximum operating temperature | 60°C (140°F) | 60°C (140°F) | ||||
| Maximum operating pressure | 30 psi (2.1 bar) @ 25°C (77°F) | 60 psi (4.1 bar) @ 25°C (77°F) | |||||
| 20 psi (1.4 bar) @ 60°C (140°F) | 30 psi (2.1 bar) @ 60°C (140°F) | ||||||
| Maximum differential pressure | Forward 30 psi (2.1 bar) @ 25°C (77°F) | Forward 60 psi (4.1 bar) @ 25°C (77°F) | |||||
| Reverse 15 psi (1.0 bar) @ 25°C (77°F) | Reverse 30 psi (2.1 bar) @ 25°C (77°F) | ||||||
| Bacteria Retention* | >107 CFU/cm2 B. diminuta per the ASTM F838. | ||||||
| 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) | ||||||
| Material toxicity* | All components meet the requirements of the USP <87>, Biological Reactivity Test | ||||||
| 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* | Non-Volatile Residue (NVR) tested at two successive 24-hour extractions in 50% ethanol with vibration per USP <665>&<1665> | ||||||
| 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 |
|---|---|---|---|
| PSTSUED022HS032 | 3" capsule | 1/2" hose barb | Two per box |
| PSTSUED022HS051 | 5" capsule | 1/2" hose barb | One per box |
| PSTSUED022HS101 | 10" capsule | 1/2" hose barb | One per box |
| PSTSUED022SH0010 | 50 mm disc | 1/4” stepped hose barb | Ten per box |
| PSTSUED022TH032 | 3" capsule | 1.5" sanitary TC inlet and 1/2" hose barb outlet | Two per box |
| PSTSUED022TH051 | 5" capsule | 1.5" sanitary TC inlet and 1/2" hose barb outlet | One per box |
| PSTSUED022TH101 | 10" capsule | 1.5" sanitary TC inlet and 1/2" hose barb outlet | One per box |
| PSTSUED022TS032 | 3" capsule | 1.5" sanitary TC | Two per box |
| PSTSUED022TS051 | 5" capsule | 1.5" sanitary TC | One per box |
| PSTSUED022TS101 | 10" capsule | 1.5" sanitary TC | One per box |
Note: Pre-sterilized capsules by Gamma irradiation available, refer to part number matrix for corresponding part number or check with your Entegris specialist. Entegris and MKS have developed compatible capsule heating jackets, available directly from MKS. Check with you Entegris specialist for more information, or visit the MKS website for Series 48 Heaters.