Biopharmaceuticals High Throughput Cartridge Filters for Vaccines Filtration

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 ºC; 1.5   bar @ 85 ºC

Integrity Test-water bubble point at 23 ºC

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 II, appendix IX 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 123ºC

Oxidizable Substances

Meets the criteria of Chinese Pharmacopoeia 2010, volume II for purified water.

Bacterial Endotoxins

< 0.25 EU/ml as determined by the LAL test