Pharmsteri™ II GSV UPE Vent Capsule Filter
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- 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 |
50mm Disc | 70.2 mm (2.76”) | 64.6 mm (2.54”) | 64.6 mm (2.54”) | 64.6 mm (2.54”) |
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 | 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 | 17.3 cm2 | 3": | 0.18 cm2 | ||||
5" | 0.33 cm2 | ||||||
10" | 0.65cm2 | ||||||
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 | 40 psi (2.8 bar) @ 25°C (77°F) | 55 psi (2.8 bar) @ 25°C (77°F) | |||||
Maximum differential pressure | Forward 30 psi (2.1 bar) @ 25°C (77°F) | Forward 50 psi (3.4 bar) @ 25°C (77°F) | |||||
Reverse 15 psi (1.0 bar) @ 25°C (77°F) | Reverse 25psi (1.7 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 24-hour extraction 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. |
Successfully Opted for software Updates
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 Tri-Clamp® | Two per box |
PSTSUED022TS051 | 5" capsule | 1.5" sanitary Tri-Clamp® | One per box |
PSTSUED022TS101 | 10" capsule | 1.5" sanitary Tri-Clamp® | One per box |