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LPTA Filter Cartridge for Air/Gas in Vaccine Filtration

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  • Description
  • Specification
  • Ordering Information

LPTA filter cartridges are featured by permanently hydrophobic PTFE membrane, specially designed for sterile venting and gas application in vaccine manufacturing. They are integrity testable, offering the highest process security, high throughputs, extreme humidity and stringent in-line steam sterilizations. These filters can be steam-sterilizable repeatedly for long service life.
Features and Benefits
● High flow rates and low pressure drop
● High strength, long service life and cost-effective
● 100% integrity testable prior to release
Quality
● Cartridges produced in a controlled environment
● Manufactured according to ISO9001 certified Quality Management System

Specification

LPTA Filter Cartridge for Air/Gas in Vaccine Filtration

Materials of Construction

Membrane

Double-layer   Polytetrafluoroethylene (PTFE)

Support  

PP

Core,   Cage and Drainage

PP

End   Caps

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

O-rings/Gasket

Silicone/EPDM/Viton/TEV

Sealing   Technology

Thermal   Bonding, No Adhesives

Dimensions

Diameter

Φ68

Length

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

Filtration Area, ft2

≥ 5.8 per 10-inch   element

Pore Size, μm

0.01 (for gas)

Maximum Differential Pressure

Forward:   4.2 bar @ 23 ; 1.5 bar @ 85

Integrity Test- at 23 ℃

Bubble point

≥ 1100 mbar with 60/40% IPA/water

HydroCorr (water intrusion   test)

≤   0.75mL/min per 10-inch cartridge with water at 2620mbar

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

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

200 steam-in-place sterilization or autoclave cycles of 30 min at 123

Bacterial Endotoxins

< 0.25 EU/ml as determined by the LAL test

 

Ordering Information

LPTA Filter Cartridge for Air/Gas in Vaccine Filtration

LPTA.jpg

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