LPTA Filter Cartridge for Air/Gas in Vaccine Filtration

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Description
Specification

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/FKM/E-FKM
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