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Description of Pharmaceutical Liquid Sterilization Filtration
WECHANFIB PO/EVOH membrane filter cartridge adopts EVOH nanofiber membrane, which is high flux, high uniformity, high compatibility and high hydrophilicity. It is widely used in removal of particles in chemical solution; removal of particles in deionized water; removal of bacteria and particles in gases and liquids of food and beverage, microelectronic and bio- pharmaceutical industries.
Application of Pharmaceutical Liquid Sterilization Filtration
Features of Pharmaceutical Liquid Sterilization Filtration
Operating Characteristic of Pharmaceutical Liquid Sterilization Filtration
| Outer Diameter | 2.7”/69mm |
| Length | 5”/127mm 10”/254mm 20”/508mm 30”/762mm 40”/1016mm |
| Pore Size | 0.1, 0.2, 0.45, 0.7, 1.0μm |
| Max. Operation Temperature | 80℃ |
| Max. Operation Pressure | Forward direction: 0.5 MPa(25±2℃) 0.24MPa(80±2℃) *It not recommend for reverse use |
| Filtration Areas | 5”≥0.34m²; 10”≥0.68m²; 20”≥1.36m² 30”≥2.04m²; 40”≥2.72m² |
| Integrity Testing | Bubble point≥60KPa 50KPa pressure,diffusion flow＜10ml/min Anhydrous ethanol was used as the wetting solution at 25°C, and compressed air was used to test the bubble point values against the diffusion flows. |
| Sterilization | 30 times (121.4℃,30 min offline high-pressure steam sterilization) |
| Bacterial Retention Capacity | Minimum retention rate 107 CFU/cm2 The product was tested against Serratia marcescens (ATCC14756) using ASTM F838 method. |
| Extractable Substance | ＜50 mg/m2 After high-pressure steam sterilization(121.4℃,60 min), 25℃±2℃ immersing in pure water for 24h |
| Biosafety | The endotoxin level＜0.25 EU/ml, and the extraction solution has no acute toxicity |
| Cleanliness | No fibers or other visible foreign objects were detected in the filtered liquid. *Lamp test according to the Chinese Pharmacopoeia 2020 edition <0904> |
Flow Rate of Pharmaceutical Liquid Sterilization Filtration
Material of Structure of Pharmaceutical Liquid Sterilization Filtration
| Filter Media | EVOH(Ethylene vinyl alcohol copolymer) |
| Deflector Layer | Polypropylene |
| Enclosures/Ports | High Temperature Resistance Polypropylene |
| Adapter | Polypropylene |
| Seals | Silicone/EPDM |
Naming Regulations of Pharmaceutical Liquid Sterilization Filtration
| WF | PL | 0500 | 10 | A | S | |
| Trademark | Form | Filtration Materials | Accuracy | length | Adapter | O ring |
| WECHANFIB | PLEATED | Blank EVOH | 0010 0.10μm | 5 5” | A 222/ FIN | S Silastic |
| 0022 0.22μm | 10 10” | B 222/Flat End Cap | E EPDM | |||
| 0045 0.45μm | 20 20” | C 226/ FIN | V FKM | |||
| 0070 0.7μm | 30 30” | D 226/ Flat End Cap | T PTFE | |||
| 0100 1.0μm | 40 40” | E DOE |
| Wechange Pleated Filter Cartridge Products List | ||||||
| Membrane Material | Type No. | Application | Pore Size | Diameter | Length | Adaptor |
| μm | mm | inch | ||||
| EVOH | WF-PL-0010-5-* | Beverage Final Filtration, Liquid Sterile Filtration, Microelectronic Liquid Filtration; CMP Polishing Liquid Filtration; Pharmaceutical Sterile Filtration; Buffer & Culture Medium Filtration; | 0.1 | 69 | 5" | The "*" Indicate type of CONNECTOR and SEAL RING, they're customizable & have below option codes: 1,Connector: A 222/Fin B 222/End Cap C 226/Fin D 226/End Cap E DOE
2,Sealing Ring: S Silicone E EDPM(Ethylene Propylene Diene Monomer) V FKM(Fluororubber) T PTFE(Polytetra- fluoroethylene) |
| EVOH | WF-PL-0010-10-* | 0.1 | 69 | 10" | ||
| EVOH | WF-PL-0010-20-* | 0.1 | 69 | 20" | ||
| EVOH | WF-PL-0010-30-* | 0.1 | 69 | 30" | ||
| EVOH | WF-PL-0010-40-* | 0.1 | 69 | 40" | ||
| EVOH | WF-PL-0022-5-* | 0.22 | 69 | 5" | ||
| EVOH | WF-PL-0022-10-* | 0.22 | 69 | 10" | ||
| EVOH | WF-PL-0022-20-* | 0.22 | 69 | 20" | ||
| EVOH | WF-PL-0022-30-* | 0.22 | 69 | 30" | ||
| EVOH | WF-PL-0022-40-* | 0.22 | 69 | 40" | ||
| EVOH | WF-PL-0045-5-* | 0.45 | 69 | 5" | ||
| EVOH | WF-PL-0045-10-* | 0.45 | 69 | 10" | ||
| EVOH | WF-PL-0045-20-* | 0.45 | 69 | 20" | ||
| EVOH | WF-PL-0045-30-* | 0.45 | 69 | 30" | ||
| EVOH | WF-PL-0045-40-* | 0.45 | 69 | 40" | ||
| EVOH | WF-PL-0070-5-* | 0.7 | 69 | 5" | ||
| EVOH | WF-PL-0070-10-* | 0.7 | 69 | 10" | ||
| EVOH | WF-PL-0070-20-* | 0.7 | 69 | 20" | ||
| EVOH | WF-PL-0070-30-* | 0.7 | 69 | 30" | ||
| EVOH | WF-PL-0070-40-* | 0.7 | 69 | 40" | ||
| EVOH | WF-PL-0100-5-* | 0.1 | 69 | 5" | ||
| EVOH | WF-PL-0100-10-* | 1 | 69 | 10" | ||
| EVOH | WF-PL-0100-20-* | 1 | 69 | 20" | ||
| EVOH | WF-PL-0100-30-* | 1 | 69 | 30" | ||
| EVOH | WF-PL-0100-40-* | 1 | 69 | 40" | ||
The nanofiber membrane filter is a high-performance filtering element, mainly composed of nanometer-scale fiber materials, which can include materials such as polypropylene, polytetrafluoroethylene (PTFE), polyethersulfone (PES), and polyvinylidene fluoride (PVDF), all of which possess excellent chemical stability and thermal resistance.
1.Drug sterile filtration
2.Culture medium filtration
3.Vaccine sterile filtration
4.Biological reagent filtration
* The nanofiber membrane filter core boasts exceptionally high filtration efficiency, enabling the effective retention of microorganisms and particles in water, air, or other fluids;
* This filter core maintains its filtration capabilities over a broad temperature range, making it suitable for filtration requirements under various temperature conditions;
* The nanofiber membrane exhibits good resistance to a variety of chemical substances, is not easily solvated or degraded by solvents, and can reliably operate in a multitude of chemical environments;
* Strict quality control system, complete production process flow;
* Short delivery period;
* Flexible payment method: T/T, L/C, West Union, Paypal;
* Free technical support;
* Other specific sizes can be customized;
Dimensions(nominal):
| OD | 69mm |
| Length | 10"(254mm),20"(508mm),30"(762mm),40"(1016mm) |
Material of Construction:
| Filter Media | Deflector layer | port | Enclosures/Ports | Seals Material |
| EVOH(Ethylene vinyl alcohol copolymer) | Polypropylene | Polypropylene | High temperature resistant polypropylene | Silastic/EPDM |
Beer Clarification Filter Cartridge Performance:
| Maximum operation temperature | 80℃ |
| Maximum operation pressure | Forward direction :0.5 MPa(25±2℃) 0.24MPa(80±2℃) It not recommend for reverse use |
| Filtration areas | ≥0.68 m²/ 10 inch ≥2.04 m²/ 30 inch |
| Integrity test | Bubble Point≥120KPa Under 80KPa,Diffusion flow＜15 ml/min 25℃, ethanol as the wetting solution |
| Sterilization | 30 times(121.4℃,30 min offline high-pressure steam sterilization) |
| Bacteria interception | Minimum interception: 107 CFU/cm2 According to standard ASTM F838, Brevundimonas subvibrioides (ATCC19146) |
| Extractable substance | ＜50 mg/m2 After high-pressure steam sterilization(121.3℃,60 min),25℃±2℃ immersing in pure water for 24h |
| Biosafety | The endotoxin level＜0.25 EU/ml, and the extraction solution has no acute toxicity |
| Cleanliness | No fibers or other visible foreign objects were detected in the filtered liquid |