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LPSD Double-layer Filter Cartridge for Lyophilized Powder

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  • Description
  • Specification
  • Ordering Information

LPSD filter cartridges are characterized by a unique highly asymmetric, double-layer hydrophilic polyethersulfone membrane, specially designed for extremely demanding of sterilizing filtration in lyophilized powder production. These filters can ensure products meeting the requirements of current regulatory.
Features and Benefits
● Double layer hydrophilic PES Membrane
● Low protein binding and extensive drug compatibility for critical applications
● Integrity testable
Quality
● Cartridges produced in a controlled environment
● Manufactured according to ISO9001 certified Quality Management System

Specification

LPSD Double-layer Filter Cartridge for Lyophilized Powder

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

Φ68

Length

5 inch, 10 inch, 20 inch, 30 inch

Filtration   Area, ft2

≥ 4.8 per 10-inch cartridge

Pore Size,   μm

0.22+0.1, 0.22+0.22,   0.45+0.22

Maximum   Differential Pressure

Forward: 4.2 bar @ 23 ;   1.5 bar @ 85

Integrity   Test-water bubble point at 23

0.22 μm + 0.1 μm

≥ 4200 mbar (60 psig)

0.22 μm + 0.22 μm

≥ 3700 mbar (53 psig)

0.45 μm + 0.22 μm

≥ 3500 mbar (50 psig)

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

≤ 50 mg after 24-h soak in   water

Effluent   Particle Level

Meets the requirements   of Chinese Pharmacopoeia 2010, Volume , appendix 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 for purified water.

Bacterial   Endotoxins

< 0.25 EU/ml as determined by the LAL test

 

Ordering Information

LPSD Double-layer Filter Cartridge for Lyophilized Powder

LPSD.jpg

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