Purcise MEC Mycoplasma Filtration Filter Cartridge 0.1μm
*Not for medical use
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Specifications
Materials | Membrane | Hydrophilic Polyethersulfone(PES) |
Support | Polypropylene(PP) | |
Core/Cage/End Cap | Polypropylene(PP) | |
Cartridge End Cap Inserts | Polybutylene terephthalate (PBT) | |
Cartrdige End Cap O-rings | Silicone/EPDM/Fluoroelastomer/PFA encapsulated O-rings | |
Filtration Area | 0.55m² |
|
Operating Conditions | Max. Operating Temperature | 80°C |
Max. Differential Pressure (Forward) | A-Standard Cartridge 0.69 MPa @ 25°C 0.40 MPa @ 60°C 0.24 MPa @ 80°C |
|
Max. Differential Pressure (Reverse) | 0.30 MPa @25°C 0.10 MPa @ 80°C |
|
Sterilization Option | A-Standard Cartridge | Can be steam sterilized for 30 minutes at 135 °C with 50 cycles (< 30 kPa); Can be autoclaved 50 cycles for 30 minutes at 130°C |
Quality Standards | Integrity | 100% Integrity testing |
Traceability | Each filter with a unique serial number | |
QMS | ISO 9001:2015 | |
Package | Pack Size | 1/pk |
Packaging | Double PE bag |
Features
- Low cytotoxicity
- Low adsorption
Applications
- Mycoplasma filtration of culture media
Regulatory Compliance
- Effluent meets the USP<788> requirement of particulate matter in large volume injection.
- Component materials meet the criteria for a “Non-fiber-releasing filter”as defined in 21 CFR 210.3(b)(6).
- Retention of 10⁷ cfu/cm² Brevundimonas diminuta(ATCC 19146) according to ASTM F838.
- Typical Log Reduction Value (LRV) >7 of Acholeplasma laidlawii (ATCC 23206) according to ASTM F838
- Aqueous extraction from a cartridge contains less than 0.25EU/ml as determined by Limulus Amebocyte Lysate (LAL), meeting requirements of USP<85>.
- Components meet the requirement of USP <87> In Vitro Biological Reactivity Test.
- Components meet the criteria of the USP <88> Biological Reactivity Test for Class V-121 °C plastics.
- Components meet the FDA indirect Food Additive requirements cited in 21 CFR177-182.
- Based on the current information from our suppliers, all components used in the manufacture of this product are animal-free.
*Contact us for more specification details.