Pharmsteri™ II GHF PES Capsule Filter
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- Pharmaceutical
- Monoclonal antibodies
- Antibody-drug conjugate (ADC)
- Gene therapies and modalities
- Bioburden reduction in buffers
- Sterile filtration of fluids used in biomanufacturing
- Intermediates and raw material filtration
Specifications
50mm Disc | 5-inch Capsule | 10-inch Capsule | ||
Materials | Media | Polyethersulfone (PES) | Polyethersulfone (PES) | Polyethersulfone (PES) |
Support | Polyester | Polyester | Polyester | |
Film edge | Polypropylene/polyethylene copolymer | Polypropylene/polyethylene copolymer | ||
Core, cage, end caps | Polypropylene | Polypropylene | Polypropylene | |
O-ring | Silicone | Silicone | Silicone | |
Sealing technology | Mechanical force by over-molding | Thermal bonding without adhesives | Thermal bonding without adhesives | |
Pore size | 0.22 µm | |||
Filtration area | 17.3 cm2 | 0.36 m2 | 0.72 m2 | |
Integrity | Bubble point | ≥3 bar (43.5 psi) air with water | - | - |
Water Diffusion | - | ≤13.0 mL/min @ 40 psi at 25°C (77°F) | ≤25.0 mL/min @ 40 psi at 25°C (77°F) | |
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 60 psi (4.1 bar) @ 25°C (77°F) | ||
Forward 30 psi (2.1 bar) @ 60°C (140°F) | ||||
Reverse 10 psi (0.7 bar) @ 25°C (77°F) | ||||
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> | |||
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 | |||
Extractabes* | Tested according to BioPhorum Operations Group (BPOG) guideline. Report is available upon request. | |||
Quality | 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 | Inlet and Outlet Connection | Vent and Drain Connection | Size | Packaging Configuration |
---|---|---|---|---|
PSTSUSA022SH003 | 1/4” stepped hose barb | Luer male with cap | 50 mm disc | Three per box |
PSTSUSA022TS051 | 1.5" sanitary Tri-Clamp® | 1/8" hose barb | 5" capsule | One per box |
PSTSUSA022TS101 | 1.5" sanitary Tri-Clamp® | 1/8" hose barb | 10" capsule | One per box |