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Pharmsteri™ II PES 0.22 Buffer Capsule Filter

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PES 0.22 µm capsule filter that delivers superior flow rates in a broad range of chemical conditions to deliver significant economic advantages.

Gamma stable and autoclavable materials of construction enable sterilization using caustics or autoclaving, or for optimal bioprocessing, integrate into single-use assemblies for gamma irradiation
Sterilizing grade meets Bacterial Challenge Test ASTM F838 to ensure that microorganisms, such as bacteria, are removed from the fluid stream while not adversely affecting the product
On site or integrator compatibility allows users the advantage of choosing to integrate buffer filters in situ to meet their own specific templates and needs
Gamma capability ensures that integrators can connect these filters into any customer-specific, single-use assembly and provide it as a sterile, final assembled product
Broad chemical compatibility allows use in a range of chemistries including acids and bases
Best-in-class flow rates meet or exceed other commercially available filters allowing increased volumes to be processed in a limited time

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Applications Pharmsteri™ II PES 0.22 Buffer Capsule Filter Applications

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

Drawings

Performance Data

Product Specifications

Pore size	0.22 µm
Materials	Media	Polyethersulfone (PES)
	Support	Polyester
	Film edge	Polypropylene/polyethylene copolymer
	Core, cage, end caps	Polypropylene
	O-ring	Silicone
Sealing technology	Thermal bonding without adhesives
Filtration area	0.72 m²
Maximum operating conditions	Maximum operating pressure	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)
		30 psi (2.1 bar) @ 60°C (140°F)
	Reverse	10 psi (0.7 bar) @ 25°C (77°F)
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.

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Reference Materials Product Documentation

Published Aug 17, 2022 Data Sheet Pharmsteri™ II PES 0.22 Buffer Capsule Filter

210.5 kB

Published Aug 17, 2022 Data Sheet Pharmsteri™ II PES 0.22 Buffer Capsule Filter - A4

210.5 kB

Published Aug 2, 2022 Manual and Guide Pharmsteri™ II PES 0.22 Buffer Capsule Filter

404.6 kB

Part Numbers

Pharmsteri™ II PES 0.22 Buffer Capsule Filter Part Numbers

Part Number	Length	Inlet and Outlet Connection	Vent and Drain Connection
PSTSUSA022TS101	10"	1.5" sanitary Tri-Clamp®	1/8" hose barb