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Sterilizing grade capsule filter 2 inch / 4 inch KMX Series

Sterilizing grade capsule filter 2 inch / 4 inch KMX Series

Eternalwater KMX series--of capsule filter products cover a variety of specifications and materials and can be applied to bioprocess filtration steps. They meet the requirements of applications from small-scale experiments to large-scale production, with superior filtration performance and reliable sterilization protection.

Industry Application
Bacterial removal filtration for large and small volume infusions
Bacterial removal filtration for Vaccines, Biologicals and Antibiotics
Bacterial removal filtration for serum and plasma separation
Bacterial removal filtration for cell culture media
Bacterial removal filtration for diagnostic reagents and preparations containing proteins, vitamins and preservatives
Disposable stock solution sterile filtration
Buffer solution filtration

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PRODUCT DESCRIPTION

Nominal size:
2inch | 4inch

Outer diameter:
67mm

Filtration area:
1200cm² | 2400cm²

Housing material:
Polypropylene

Center pole material:
Polypropylene

Support layer material:
Polypropylene

Vent O-ring Material:
Silicone

Vent /Drain Outlet Diameter:
Φ4mm

Maximum Operating Pressure Difference:
4 bar (58 psi) at 25°C

Housing pressure:
5.5 bar (80 psi) at 25°C

Sterilization:
Can be sterilized by Gamma radiation up to 45KGy Can be sterilized by high-pressure steam at 126°C for 30 minutes three times (in-line steam sterilization is not available)

Bacterial Endotoxin:
According to the bacterial endotoxin test method stipulated in the general rule (1143) of the Chinese Pharmacopoeia 2020 edition. As determined by Limulus reagent (LAL), the aqueous extract content is < 0.25 EU/mL

Microbial Challenge Test:
>10⁷cuf/cm²; according to ASTM® test method passed Pseudomonas diminuta (B. diminuta) ( ATCC® 19146)

Biosecurity:
All materials meet USP <88> Reaction Test Standards for Plastic Materials Class VI-70°C

TOC/Conductivity:
TOC value≤0.5mg/L, conductivity value≤1.3us/cm. According to the Chinese Pharmacopoeia 2020 Edition, the general rule (0682) the determination method of total organic carbon in pharmaceutical water and the general rule (0681) the determination method of the conductivity of pharmaceutical water

Cleanliness:
According to the light inspection method stipulated in the general rules (0904) of the Chinese Pharmacopoeia 2020 edition, no fibers and other visible foreign matter were detected in the filtrate