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Membrane PTFE Filter Cartridges
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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 14233.2of 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


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