MCE 0.45μm Cartridge Filters
Product Specifications
| 10 inch | 20 inch | 30 inch | |
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Dimensions Diameter |
69 mm |
69 mm |
69 mm |
| Filtration Area | 0.68 m2 | 1.32 m2 | 1.98 m2 |
| Pore Size | 0.2 μm | ||
| Materials of Construction |
Filter membrane:Mixed Cellulose Ester Supporting Layer: Polypropylene (PP) Liner / Cartridge body: Polypropylene (PP) |
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| Maximum Differential Pressure |
Forward: 5 bar ( 72.5 psi ) @ 25℃ / 1.5 bar ( 21.75 psi ) @ 80℃ / Reverse: 2 bar ( 29 psi ) @ 25℃ | ||
| Sterilization Parameters | 121℃, 30 minutes, 5 cycles of high-pressure sterilizations or 5 cycles of sterilization in place | ||
| Extractable | Water: ~20 mg / 10 inch Ethanol: water ( 50：50 ): ~55 mg / 10 inch |
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| Biological Safety | All the construction components of this cartridge comply with the requirements for biological safety of Class VI plastics in current USP < 88 > | ||
| Indirect Food Additive | The primary construction components of this cartridge comply with the reguirements for food contact materials as stipulated in EU 1935 / 2004 / EC and FDA 21 CFR 177-182 | ||
| Cleanliness | Cleanliness meets the requirements for nonfiber releasing filter as specified in FDA 21 CFR 211.72 and 210.3 (b) (5) (6), and the level of insoluble particles in rinsing liquid meets the requirements of USP < 788 > |
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| Endotoxin | The endotoxin level of cartridge rinsing liquid is < 0.25 EU/mL as indicated by gel method, which complies with the requirements of USP < 85 > | ||
| Integrity | Each filter has passed the integrity test | ||
| TOC / Conductivity | TOC < 0.5 mg/L, Conductivity < 1.3 μS/cm | ||
| Manufacturing environment | Manufactured in conformance with cGMP | ||
Test Results of Flow Differential Pressure
