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Filter Cartridge

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Filter Cartridge

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Membrane MCE filter cartridges

Specification:

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

Materials of Construction

Membrane

Hydrophilic   MCE

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

Φ68

Length

5 inch, 10 inch, 20 inch, 30 inch, 40 inch

Filtration Area, ft2

≥ 6.4 per 10-inch   element

Pore Size, μm       

0.1, 0.22, 0.45, 0.65,   1.0, 3.0, 5.0

Maximum Differential Pressure

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

Bacterial Retention (for 0.1 and 0.22 μm only)

Passed the bacterial   challenge testing using Brevundimonas
diminuta
(ATCC19146) at a minimum challenge concentration
of 1 x 105 CFU/cm2.

Extractables, per 10-inch cartridge

≤ 50 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

15 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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LPM filter cartridges are characterized by high-performance, hydrophilic mixed cellulose esters membrane, offering high flow rates, low protein adsorption and superior microbiological safety. These filters are designed to reduce costs and are especially suited for in prefiltration of vaccines.

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
● Low protein binding
● Superior throughputs and cost-effective
● High retention efficiency for more critical degrees of prefiltration

Plasma Fractionation
Sterile Injection Powder
Vaccines
Sterile Injection Powder

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CMP Slurry Filtration
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Water Filtration
Chemicals Filtration


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