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Filter Cartridge

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Filter Cartridge

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Membrane PVDF filter cartridges

Specification:

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

Materials of Construction

Membrane

Double Layer Hydrophilic PES

Support

PP

Core, Cage and Drainage

PP

End Caps

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

O-rings/Gasket

Silicone/EPDM/Viton

Sealing technology

Thermal Bonding, No Adhesives

Dimensions

Diameter

Φ70

Length

5 inch, 10 inch, 20 inch, 30 inch

Filtration   Area, ft2

≥ 4.9 per 10-inch cartridge

Pore Size, μm

0.45+0.22

Maximum Differential Pressure

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, per 10-inch cartridge

≤ 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).

Toxicity

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℃

Oxidizable Substances

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

Bacterial Endotoxins

< 0.25 EU/ml as determined by the LAL test

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LPSL filter cartridges are specially designed for sterilizing filtration of plasma fractionation. They are featuring extremely low extractables with no more than 10mg/10”, longer service life with 40 cycles of SIP. These filters can powerfully ensure final product quality.

Quality
● Cartridges produced in a controlled environment
● Manufactured according to ISO9001 certified Quality Management System

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

Features and Benefits
● Double layer hydrophilic PES Membrane
● Low protein binding
● Extensive drug compatibility for critical applications
● Extremely low extractables

Plasma Fractionation
Sterile Injection Powder
Vaccines
Sterile Injection Powder

Small & Large Volume Parenterals
Plasma Fractionation
Ophthalmic Solutions
Facilities Water
Cell Culture Media Preparation
Active Pharmaceutical Ingredients
Beer Filtration
Wine Filtration
Bottled Water Filtration
Soft Drink Filtration
Dairy Filtration
High Fructose Syrup Filtration
Semicon Filtration
Ultrapure/DI Water Filtration
Photoresist Filtration
Display Filtration
CMP Slurry Filtration
Inkjet Inks Filtration
Water Filtration
Chemicals Filtration


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