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Description of Pharmaceutical Liquid Sterilization Filtration
WECHANFIB PES Nanofiber Membrane Filter Cartridge use a high-performance, pleated PES membrane. The ideal choice for the filtration in the bio-pharmaceutical, food and beverage industry. PES filter cartridges are especially designed for effective bioburden control and reliable removal of particles from a broad range of fluid streams. They provide the finest, most efficient and reliable performance for critical prefiltration applications.
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, 0.65, 0.8, 1.2, 3.0μm |
Max. Operation Temperature | 80℃ |
Max. Operation Pressure | Forward direction: 0.58 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<10 ml/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 | PES(Polyether-sulfone) |
Deflector Layer | Polypropylene |
Enclosures/Ports | High Temperature Resistance Polypropylene |
Adapter | Polypropylene |
Seals | Silicone/EPDM |
Naming Regulations of Pharmaceutical Liquid Sterilization Filtration
WF | PL | S | 0500 | 10 | A | S |
Trademark | Form | Filtration Materials | Accuracy | length | Adapter | O ring |
WECHANFIB | PLEATED | PES | 0010 0.10μm | 5 5” | A 222/ FIN | S Silicone |
0022 0.22μm | 10 10” | B 222/Flat End Cap | E EPDM | |||
0045 0.45μm | 20 20” | C 226/ FIN | V FKM | |||
0065 0.65μm | 30 30” | D 226/ Flat End Cap | T PTFE | |||
0080 0.8μm | 40 40” | E DOE |
Wechange Pleated Filter Cartridge Products List | ||||||
Membrane Material | Type No. | Application | Pore Size | Diameter | Length | Adaptor |
μm | mm | inch | ||||
PES | WF-PL-S-0010-5-* | Beverage Final Filtration, Microelectronics Liquid Filtration, Liquid Sterile Filtration, Buffer & Culture Medium Filtration, Biological Products Sterile Filtration. | 0.1 | 69 | 5" | The "*" Indicate type of CONNECTOR & SEAL RING, they're customiz-able and have below option codes: 1,Connector: A 222/Fin B 222/Flat End Cap C 226/Fin D 226/Flat End Cap E DOE
2,Sealing Ring: S Silicone E EDPM(Ethylene Propylene Diene Monomer) V FKM (Fluororubber) T PTFE(Polytetra- fluoroethylene) |
PES | WF-PL-S-0010-10-* | 0.1 | 69 | 10" | ||
PES | WF-PL-S-0010-20-* | 0.1 | 69 | 20" | ||
PES | WF-PL-S-0010-30-* | 0.1 | 69 | 30" | ||
PES | WF-PL-S-0010-40-* | 0.1 | 69 | 40" | ||
PES | WF-PL-S-0022-5-* | 0.22 | 69 | 5" | ||
PES | WF-PL-S-0022-10-* | 0.22 | 69 | 10" | ||
PES | WF-PL-S-0022-20-* | 0.22 | 69 | 20" | ||
PES | WF-PL-S-0022-30-* | 0.22 | 69 | 30" | ||
PES | WF-PL-S-0022-40-* | 0.22 | 69 | 40" | ||
PES | WF-PL-S-0045-5-* | 0.45 | 69 | 5" | ||
PES | WF-PL-S-0045-10-* | 0.45 | 69 | 10" | ||
PES | WF-PL-S-0045-20-* | 0.45 | 69 | 20" | ||
PES | WF-PL-S-0045-30-* | 0.45 | 69 | 30" | ||
PES | WF-PL-S-0045-40-* | 0.45 | 69 | 40" | ||
PES | WF-PL-S-0065-5-* | 0.65 | 69 | 5" | ||
PES | WF-PL-S-0065-10-* | 0.65 | 69 | 10" | ||
PES | WF-PL-S-0065-20-* | 0.65 | 69 | 20" | ||
PES | WF-PL-S-0065-30-* | 0.65 | 69 | 30" | ||
PES | WF-PL-S-0065-40-* | 0.65 | 69 | 40" | ||
PES | WF-PL-S-0080-5-* | 0.8 | 69 | 5" | ||
PES | WF-PL-S-0080-10-* | 0.8 | 69 | 10" | ||
PES | WF-PL-S-0080-20-* | 0.8 | 69 | 20" | ||
PES | WF-PL-S-0080-30-* | 0.8 | 69 | 30" | ||
PES | WF-PL-S-0080-40-* | 0.8 | 69 | 40" | ||
PES | WF-PL-S-0120-5-* | 1.2 | 69 | 5" | ||
PES | WF-PL-S-0120-10-* | 1.2 | 69 | 10" | ||
PES | WF-PL-S-0120-20-* | 1.2 | 69 | 20" | ||
PES | WF-PL-S-0120-30-* | 1.2 | 69 | 30" | ||
PES | WF-PL-S-0120-40-* | 1.2 | 69 | 40" | ||
PES | WF-PL-S-0300-5-* | 3 | 69 | 5" | ||
PES | WF-PL-S-0300-10-* | 3 | 69 | 10" | ||
PES | WF-PL-S-0300-20-* | 3 | 69 | 20" | ||
PES | WF-PL-S-0300-30-* | 3 | 69 | 30" | ||
PES | WF-PL-S-0300-40-* | 3 | 69 | 40" |
The PES membrane filter is specifically designed for sterilization filtration of pharmaceutical liquids in the pharmaceutical industry. It is made of polyether sulfone (PES) material, which has good chemical stability, high heat resistance, and is suitable for filtering a variety of pharmaceutical liquids. It is suitable for the sterilization filtration of pharmaceutical liquids to ensure product quality and patient safety.
1.Biological drugs sterile filtration
2.Blood products filtration
3.Buffer solution and culture medium sterile filtration
4.Pre filtration for virus removal
* It boasts high filtration efficiency, effectively retaining bacteria, viruses, particles, and other microorganisms, ensuring the aseptic nature of pharmaceutical liquids;
* It has a broad temperature tolerance, maintaining stable filtration performance at high temperatures, making it suitable for high-temperature sterilization processes;
* It has good resistance to a variety of chemicals, and is not easily dissolved or degraded by solvents;
* 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 |
PES( polyether sulphone ) | 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 |