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LPSL Low Extractable and Longer Service Life Filter Cartridge for Lyophilized Powder

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  • Description
  • Specification
  • Ordering Information

LPSL filter cartridges are specially designed for sterilizing filtration of lyophilized powder. 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 products meeting requirements of current regulatory.
Features and Benefits
● Double layer hydrophilic PES Membrane 
● Low protein binding
● Extensive drug compatibility for critical applications 
● Extremely low extractables
Quality
● Cartridges produced in a controlled environment
● Manufactured according to ISO9001 certified Quality Management System

Specification

LPSL Low Extractable and Longer Service Life 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

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 , 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

40 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

LPSL Low Extractable and Longer Service Life Filter Cartridge for Lyophilized Powder

 

 

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