Pharmsteri™ II GSV UPE Vent Capsule Filter
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Notes:
1. TS/HS/TH/RS/TR code for 3”/5”/10”, FS/BS/FB code for 1”, SH code for 50mm disc;
2. 5”/10” as 1 ea/box, 3” as 2 ea/box, 1” as 4 ea/box, 50mm disc as 10 ea/box;
3. Entegris and MKS have developed compatible capsule heating jackets, available directly from MKS. Check with your Entegris specialist for more information, or visit the MKS website for Series 48 Heaters.
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Reference Materials
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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 |
| 1-inch 3/4" TC-3/4" TC | 102.5 mm (4.04") | 69.2 mm (2.72") | 75.1 mm (2.96") | 101.9 mm (4.01") |
| 1-inch 3/4" TC-1/4" HB | 108.0 mm (4.25") | 69.2 mm (2.72") | 75.1 mm (2.96") | 101.9 mm (4.01") |
| 1-inch 1/4" HB-1/4" HB | 113.5 mm (4.47") | 69.2 mm (2.72") | 75.1 mm (2.96") | 101.9 mm (4.01") |
| 3-inch 1.5" TC-1.5" TC | 154.5 mm (6.08”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 3-inch 1/5" TC-1/2" HB | 156.7 mm (6.17”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 3-inch 1/2" HB-1/2" HB | 159.7 mm (6.29”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 3-inch 1.5" TC-3/8" HB | 152.5 mm (6.00") | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 3-inch 3/8" HB-3/8" HB | 150.5 mm (5.93") | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 5-inch 1.5" TC-1.5" TC | 213.2 mm (8.39”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 5-inch 1.5" TC-1/2" HB | 216.5 mm (8.52”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 5-inch 1/2" HB-1/2" HB | 219.5 mm (8.96”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 5-inch 1.5" TC-3/8" HB | 211.6 mm (8.33") | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 5-inch 3/8" HB-3/8" HB | 210.0 mm (8.27") | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 10-inch 1.5" TC-.1.5" TC | 335.5 mm (13.21”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 10-inch 1.5" TC-1/2" HB | 339.0 mm (13.35”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 10-inch 1/2" HB-1/2" HB | 342.0 mm (13.46”) | 96.0 mm (3.78”) | 107.0 mm (4.21”) | 153.0 mm (6.02”) |
| 50mm Disc | 1"/3"/5"/10" In-line Capsule | ||||||
| Materials | Media | Polyethylene | Polyethylene | ||||
| 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 | 1" | 500 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 | ||||
| Diffusion flow | NA | 1" | ≤1.35 mL/min @1.10 bar, 60% IPA with water | ||||
| 3"/5"/10" | NA | ||||||
| Water intrusion | NA | 1" | NA | ||||
| 3" | ≤0.25 mL/min @2.62 bar | ||||||
| 5" | ≤0.43 mL/min @2.62 bar | ||||||
| 10" | ≤0.55 mL/min @2.62 bar | ||||||
| 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) | 1" | 80 psi (5.5 bar) @ 25°C (77°F) | ||||
| 3"/5"/10" | 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 forward differential pressure | 30 psi (2.1 bar) @ 25°C (77°F) | 1" | 30 psi (2.1 bar) @ 25°C (77°F) | ||||
| 3"/5"/10" | 60 psi (4.1 bar) @ 25°C (77°F) | ||||||
| Maximum reverse differential pressure | 15 psi (1.0 bar) @ 25°C (77°F) | 1" | 15 psi (1.0 bar) @ 25°C (77°F) | ||||
| 3"/5"/10" | 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 | Capsule Type | Membrane/Media | Code and O-ring | Packaging Configuration |
|---|---|---|---|---|---|
| PSTGSED022BS01-4 | 1" capsule | Gamma Sterilized | UPE | 1/4" HB inlet/outlet, silicone O-ring | 4 ea/box |
| PSTGSED022FB01-4 | 1" capsule | Gamma Sterilized | UPE | 3/4" TC inlet, 1/4" HB outlet | 4 ea/box |
| PSTGSED022FS01-4 | 1" capsule | Gamma Sterilized | UPE | 3/4" TC inlet/outlet, silicone O-ring | 4 ea/box |
| PSTGSED022HS03-2 | 3" capsule | Gamma Sterilized | UPE | 1/2" HB inlet/outlet, silicone O-ring | 2 ea/box |
| PSTGSED022HS05-1 | 5" capsule | Gamma Sterilized | UPE | 1/2" HB inlet/outlet, silicone O-ring | 1 ea/box |
| PSTGSED022HS10-1 | 10" capsule | Gamma Sterilized | UPE | 1/2" HB inlet/outlet, silicone O-ring | 1 ea/box |
| PSTGSED022SH00-10 | 50 mm disc | Gamma Sterilized | UPE | HB inlet/outlet, disc only | 10 ea/box |
| PSTGSED022TH03-2 | 3" capsule | Gamma Sterilized | UPE | 1.5" TC inlet, 1/2" HB outlet | 2 ea/box |
| PSTGSED022TH05-1 | 5" capsule | Gamma Sterilized | UPE | 1.5" TC inlet, 1/2" HB outlet | 1 ea/box |
| PSTGSED022TH10-1 | 10" capsule | Gamma Sterilized | UPE | 1.5" TC inlet, 1/2" HB outlet | 1 ea/box |
| PSTGSED022TS03-2 | 3" capsule | Gamma Sterilized | UPE | 1.5" TC inlet/outlet, silicone O-ring | 2 ea/box |
| PSTGSED022TS05-1 | 5" capsule | Gamma Sterilized | UPE | 1.5" TC inlet/outlet, silicone O-ring | 1 ea/box |
| PSTGSED022TS10-1 | 10" capsule | Gamma Sterilized | UPE | 1.5" TC inlet/outlet, silicone O-ring | 1 ea/box |
| PSTSUED022BS01-4 | 1" capsule | Single Use | UPE | 1/4" HB inlet/outlet, silicone O-ring | 4 ea/box |
| PSTSUED022FB01-4 | 1" capsule | Single Use | UPE | 3/4" TC inlet, 1/4" HB outlet | 4 ea/box |
| PSTSUED022FS01-4 | 1" capsule | Single Use | UPE | 3/4" TC inlet/outlet, silicone O-ring | 4 ea/box |
| PSTSUED022HS03-2 | 3" capsule | Single Use | UPE | 1/2" HB inlet/outlet, silicone O-ring | 2 ea/box |
| PSTSUED022HS05-1 | 5" capsule | Single Use | UPE | 1/2" HB inlet/outlet, silicone O-ring | 1 ea/box |
| PSTSUED022HS10-1 | 10" capsule | Single Use | UPE | 1/2" HB inlet/outlet, silicone O-ring | 1 ea/box |
| PSTSUED022RS03-2 | 3" capsule | Single Use | UPE | 3/8" HB inlet/outlet, silicone O-ring | 2 ea/box |
| PSTSUED022RS05-1 | 5" capsule | Single Use | UPE | 3/8" HB inlet/outlet, silicone O-ring | 1 ea/box |
| PSTSUED022SH00-10 | 50 mm disc | Single Use | UPE | HB inlet/outlet, disc only | 10 ea/box |
| PSTSUED022TH03-2 | 3" capsule | Single Use | UPE | 1.5" TC inlet, 1/2" HB outlet | 2 ea/box |
| PSTSUED022TH05-1 | 5" capsule | Single Use | UPE | 1.5" TC inlet, 1/2" HB outlet | 1 ea/box |
| PSTSUED022TH10-1 | 10" capsule | Single Use | UPE | 1.5" TC inlet, 1/2" HB outlet | 1 ea/box |
| PSTSUED022TR03-2 | 3" capsule | Single Use | UPE | 1.5" TC inlet, 3/8" HB outlet | 2 ea/box |
| PSTSUED022TR05-1 | 5" capsule | Single Use | UPE | 1.5" TC inlet, 3/8" HB outlet | 1 ea/box |
| PSTSUED022TS03-2 | 3" capsule | Single Use | UPE | 1.5" TC inlet/outlet, silicone O-ring | 2 ea/box |
| PSTSUED022TS05-1 | 5" capsule | Single Use | UPE | 1.5" TC inlet/outlet, silicone O-ring | 1 ea/box |
| PSTSUED022TS10-1 | 10" capsule | Single Use | UPE | 1.5" TC inlet/outlet, silicone O-ring | 1 ea/box |
Notes:
1. TS/HS/TH/RS/TR code for 3”/5”/10”, FS/BS/FB code for 1”, SH code for 50mm disc;
2. 5”/10” as 1 ea/box, 3” as 2 ea/box, 1” as 4 ea/box, 50mm disc as 10 ea/box;
3. Entegris and MKS have developed compatible capsule heating jackets, available directly from MKS. Check with your Entegris specialist for more information, or visit the MKS website for Series 48 Heaters.