Pharmsteri™ II GHC PES LiquidCapsule Filter
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- 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 | A Total Length mm | B Body Diameter mm | C Min Width mm | D Max Width mm |
3-inch TC-TC | 154.0 | 96.0 | 107.0 | 153.0 |
3-inch TC-HB | 157.0 | 96.0 | 107.0 | 153.0 |
3-inch HB-HB | 160.0 | 96.0 | 107.0 | 153.0 |
5-inch TC-TC | 213.0 | 96.0 | 107.0 | 153.0 |
5-inch TC-HB | 216.0 | 96.0 | 107.0 | 153.0 |
5-inch HB-HB | 219.0 | 96.0 | 107.0 | 153.0 |
10-inch TC-TC | 335.0 | 96.0 | 107.0 | 153.0 |
10-inch TC-HB | 338.0 | 96.0 | 107.0 | 153.0 |
10-inch HB-HB | 341.0 | 96.0 | 107.0 | 153.0 |
50mm Disc | In-Line Capsules (3", 5", 10") | |||||
Materials | Media | Polyethersulfone | ||||
Support | Polypropylene | |||||
Core, cage, end caps | Polypropylene | |||||
O-ring | Silicone | |||||
Sealing technology | Mechanical force | Thermal bonding without adhesives | ||||
Pore size | 0.45+0.22 µm | |||||
Filtration area | 17.3 cm2 | 0.16 m2 (3") | ||||
0.30 m2 (5") | ||||||
0.60 m2 (10") | ||||||
Integrity | Bubble point | ≥3.65 bar (53 psi) air with water | ||||
Water Diffusion | ≤ 11 mL/min (5 inch) | |||||
≤ 20.5 mL/min (10 inch) | ||||||
@ 40 psi at 25°C | ||||||
Maximum operating conditions | Maximum operating pressure | 60 psi (4.1 bar) @ 25°C (77°F) | 80 psi (5.5 bar) @ 25°C (77°F) | |||
40 psi (2.8 bar) @ 60°C (140°F) | ||||||
Maximum differential pressure | Forward 60 psi (4.1 bar) @ 25°C (77°F) | Forward 50 psi (3.4 bar) @ 25°C (77°F) | ||||
30 psi (2.1 bar) @ 60° C (140° F) | ||||||
Reverse 25psi (1.7 bar) @ 25°C (77°F) | ||||||
Inlet/Outlet | 1.5" sanitary TC inlet & outlet | |||||
½" hose barb inlet & outlet | ||||||
1.5" sanitary TC inlet & 1/2" hose barb outlet | ||||||
Vent/Drain | 1/4” stepped hose barb | 1/8" hose barb with valve | ||||
Bacteria Retention | >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
Part Number | Size | Inlet and Outlet Connection | Packaging Configuration |
---|---|---|---|
PSTSUSD042HS032 | 3" capsule | 1/2" hose barb | Two per box |
PSTSUSD042HS051 | 5" capsule | 1/2" hose barb | One per box |
PSTSUSD042HS101 | 10" capsule | 1/2" hose barb | One per box |
PSTSUSD042SH003 | 50 mm disc | 1/4” stepped hose barb | Three per box |
PSTSUSD042TH032 | 3" capsule | 1.5" sanitary TC inlet and 1/2" hose barb outlet | Two per box |
PSTSUSD042TH051 | 5" capsule | 1.5" sanitary TC inlet and 1/2" hose barb outlet | One per box |
PSTSUSD042TH101 | 10" capsule | 1.5" sanitary TC inlet and 1/2" hose barb outlet | One per box |
PSTSUSD042TS032 | 3" capsule | 1.5" sanitary Tri-Clamp® | Two per box |
PSTSUSD042TS051 | 5" capsule | 1.5" sanitary Tri-Clamp® | One per box |
PSTSUSD042TS101 | 10" capsule | 1.5" sanitary Tri-Clamp® | One per box |