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Cartucho de filtro

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Cartucho de filtro

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Cartuchos de filtro de membrana Pes

especificación:

LPSL Low Extractable and Longer Service Life Filter Cartridge for Plasma Fractionation

Materiais de Construción

Membrana

Double Layer Hydrophilic PES

apoio

PP

Core, Cage and Drainage

PP

Tapóns finais

PP (222/226 with encapsulated stainless  
steel reinforcing ring)

Anillos tóricos / xunta

Silicona / EPDM / Viton

Tecnoloxía de selado

Enlace térmico, sen adhesivos

dimensións

diámetro

Φ70

lonxitude

5 inch, 10 inch, 20 inch, 30 inch

Filtration   Area, ft2

≥ 4.9 per 10-inch cartridge

Pore Size, μm

0.45 + 0.22

Presión diferencial máxima

Forward: 4.2 bar @ 23 ℃; 1.5   bar @ 85 ℃

Integrity Test at 23 

Water bubble point

≥ 3500 mbar (50 psig)

Diffusive flow

≤ 30ml/min/10”@2.8bar

Bacterial Retention

Passed the bacterial   challenge testing using Brevundimonas
diminuta
 (ATCC19146) at a minimum challenge concentration of 1 x 107 CFU/cm2.

Extractables por cartucho de 10 polgadas

≤ 10 mg after 24-h soak in   water

Effluent Particle Level

Meets the requirements   of Chinese Pharmacopoeia 2010, Volume Ⅱ, appendix Ⅸ C.

Non-Fiber Releasing

Meets the criteria for   a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6).

Toxicidade

Component materials   meet GB/T 14233.2<2005>of Chinese
National Standard for Safety Tests.

TOC

< 500 ppb after a water flush of 60 liters per 10-inch cartridge

Multiple Sterilization Cycles

40 steam-in-place sterilization or autoclave cycles of 30 min at 123℃

Substancias oxidables

Meets the criteria of Chinese Pharmacopoeia 2010, volume Ⅱ for purified water.

Endotoxinas bacterianas

< 0.25 EU/ml as determined by the LAL test

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Os cartuchos de filtro LPSL están deseñados especialmente para esterilizar a filtración de fraccionamento de plasma. Ofrecen extractibles extremadamente baixos con non máis de 10mg / 10 ", unha vida útil máis longa con 40 ciclos de SIP. Estes filtros poden garantir a calidade do produto final.

Calidade
● Cartuchos producidos nun ambiente controlado
● Fabricado segundo o sistema de xestión de calidade certificado ISO9001

Información sobre pedidos
LPSL Low Extractable and Longer Service Life Filter Cartridge for Plasma Fractionation

Características e beneficios
● Double layer hydrophilic PES Membrane
● Low protein binding
● Extensive drug compatibility for critical applications
● Extremely low extractables

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