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Home | Biopharmaceuticals | Bioburden Reduction| Duredunty Filters-Sterilizing Grade & Mycoplasma Removal

Duredunty Filters-Sterilizing Grade & Mycoplasma Removal

Cobetter Duredunty^® filters are consisting of double layer PES membranes and designed for sterilizing grade filtration and mycoplasma removal in special application of biopharmaceutical process.

Features and Benefits

Double-layered membrane provides great reliability of sterilization and mycoplasma removal
Asymmetric PES membranes provides longer service life and lower filtration cost
Broad chemical compatibility

Regulatory Compliance

Manufactured under a quality management system certified to ISO9001:2008
Each individual element is integrity tested(bubble point&diffusion flow)
Each individual element is tracked by series number for traceability and easy identification

Application

Chemically defined cell culture media
Serum
Plant peptone
Clarified cell culture harvest

Available Formats

GM series capsule filters
Filter Cartridges

Specifications

Filter Media	Polyethersulfone
Support Fleece	Polypropylene
Polypropylene	Polypropylene
Polypropylene	Forward: 5.0 bar/ 21℃ 3.0 bar/ 60℃ 2.4 bar/ 80℃
Bacterial Endotoxin	<0.25EU/mL, according to LAL Test
Bacterial Retention 0.1μm 0.22μm	Retention of 10⁷ CFU/cm² Brevundimonas diminuta (ATCC®19146) according to ASTM F838.
Mycoplasma Retention 0.1μm	Tested with A.laidlawii ATCC® 23206 (LRV>7).
Component Material Toxicity	Meets USP Biological reactivity test for class VI-121℃ plastics
Extractables	Meets or exceed the requirements for WFI quality standards set by the current USP
Sterilization	Capsules -Gamma compatible to 45 kGy -Autoclaved for 25 cycles of 30minutes at 136℃.(Cannot be steam sterilized in-line) Cartridges -Autoclaved for 25 cycles of 30 minutes at 136℃. -Steam sterilized in-line for 25 cycles of 30minutes at 136℃.