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LPSHT High Throughput Filter Cartridge for Vaccines

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  • Description
  • Specification
  • Ordering Information

LPSHT filter cartridges are integrity testable membrane filters specially developed for sterilizing filtration of vaccines. They are characterized by a unique highly asymmetric, hydrophilic polyethersulfone membrane, offering higher throughputs, low protein adsorption and superior microbiological safety.
Features and Benefits
● Highly asymmetric, hydrophilic polyethersulfone membrane
● Absolute bacteria retention
● Long service life and high flow rates
Quality
● Cartridges produced in a controlled environment
● Manufactured according to ISO9001 certified Quality Management System

Specification

LPSHT High Throughput Filter Cartridge for Vaccines

Materials of Construction

Membrane

Single 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, 40 inch

Filtration   Area, ft2

≥ 5.7 per 10-inch cartridges

Pore Size, μm

0.1, 0.22, 0.45, 0.65,   0.8, 1.2, 3.0

Maximum Differential Pressure

Forward: 4.2 bar @ 23 ; 1.5   bar @ 85

Integrity Test-water bubble point at 23 ℃

0.1 μm

≥ 3800 mbar (58 psig)

0.22 μm

≥ 3400 mbar (49 psig)

0.45 μm

≥ 2300 mbar (33 psig)

0.65 μm

≥ 1300 mbar (19 psig)

0.8 μm

≥ 600 mbar (8 psig)

1.2 μm

≥ 400 mbar (6 psig)

Bacterial Retention (for 0.1 μm & 0.22 μm only)

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

LPSHT High Throughput Filter Cartridge for Vaccines

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