Wuhan Wechange Technology Co., Ltd
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Description of Pharmaceutical Air Sterilization Filtration
PTFE membrane filters providing the utmost assurance of chemical resistance, durability and critical filtration performance in aggressive fluids.
WECHANGE PTFE(polytetrafluoroethylene) membrane filters cartridge offer the highest level of assurance of chemical compatibility and filtration performance in aggressive chemicals, prolonged hot air service and other severe process conditions.
Our products delivers superior flow rates and long service life. The highly porous membrane is inherently hydrophobic and offers maximum chemical compatibility with minimal extractables in a wide range of fluids and applications. Support components are all-polypropylene.
Application of Pharmaceutical Air Sterilization Filtration
Features of Pharmaceutical Air Sterilization Filtration
Operating Characteristic of Pharmaceutical Air 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, 1.0, 3.0, 10μm |
| 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≥60 KPa Under 50 KPa,Diffusion flow＜15 ml/min 25℃, ethanol as the wetting solution |
| 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 Air Sterilization Filtration
Material of Structure of Pharmaceutical Air Sterilization Filtration
| Filter Media | PTFE |
| Deflector Layer | Polypropylene |
| Enclosures/Ports | High Temperature Resistance Polypropylene |
| Adapter | Polypropylene |
| Seals | Silicone/EPDM |
Naming Regulations of Pharmaceutical Air Sterilization Filtration
| WF | PL | F | 0045 | 05 | M | S |
| Trademark | Form | Filtration Materials | Accuracy | length | Adapter | O ring |
| WECHANFIB | PLEATED | PTFE | 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 | |||
| 0100 1μm | 30 30” | D 226/ Flat End Cap | T PTFE | |||
| 0300 3μm | 40 40” | E DOE | ||||
| 1000 10μm |
| Wechange Pleated Filter Cartridge Products List | ||||||
| Membrane Material | Type No. | Application | Pore Size | Diameter | Length | Adaptor |
| μm | mm | inch | ||||
| PTFE | WF-PL-F-0005-5-* | Air Sterilization Filtration, Photoresist Filtration, Microelectronic Liquid Filtration, Semiconductor Process Gas Line Filtration, Crossive Solvent & Strong Oxidizing Liquid Impurity Filtration. | 0.05 | 69 | 5" | The "*" Indicate type of CONNECTOR and SEAL RING, they're customizable and have below option codes: (Fluororubber) |
| PTFE | WF-PL-F-0005-10-* | 0.05 | 69 | 10" | ||
| PTFE | WF-PL-F-0005-20-* | 0.05 | 69 | 20" | ||
| PTFE | WF-PL-F-0005-30-* | 0.05 | 69 | 30" | ||
| PTFE | WF-PL-F-0005-40-* | 0.05 | 69 | 40" | ||
| PTFE | WF-PL-F-0010-5-* | 0.1 | 69 | 5" | ||
| PTFE | WF-PL-F-0010-10-* | 0.1 | 69 | 10" | ||
| PTFE | WF-PL-F-0010-20-* | 0.1 | 69 | 20" | ||
| PTFE | WF-PL-F-0010-30-* | 0.1 | 69 | 30" | ||
| PTFE | WF-PL-F-0010-40-* | 0.1 | 69 | 40" | ||
| PTFE | WF-PL-F-0020-5-* | 0.2 | 69 | 5" | ||
| PTFE | WF-PL-F-0020-10-* | 0.2 | 69 | 10" | ||
| PTFE | WF-PL-F-0020-20-* | 0.2 | 69 | 20" | ||
| PTFE | WF-PL-F-0020-30-* | 0.2 | 69 | 30" | ||
| PTFE | WF-PL-F-0020-40-* | 0.2 | 69 | 40" | ||
| PTFE | WF-PL-F-0045-5-* | 0.45 | 69 | 5" | ||
| PTFE | WF-PL-F-0045-10-* | 0.45 | 69 | 10" | ||
| PTFE | WF-PL-F-0045-20-* | 0.45 | 69 | 20" | ||
| PTFE | WF-PL-F-0045-30-* | 0.45 | 69 | 30" | ||
| PTFE | WF-PL-F-0045-40-* | 0.45 | 69 | 40" | ||
| PTFE | WF-PL-F-0100-5-* | 1 | 69 | 5" | ||
| PTFE | WF-PL-F-0100-10-* | 1 | 69 | 10" | ||
| PTFE | WF-PL-F-0100-20-* | 1 | 69 | 20" | ||
| PTFE | WF-PL-F-0100-30-* | 1 | 69 | 30" | ||
| PTFE | WF-PL-F-0100-40-* | 1 | 69 | 40" | ||
| PTFE | WF-PL-F-0300-5-* | 3 | 69 | 5" | ||
| PTFE | WF-PL-F-0300-10-* | 3 | 69 | 10" | ||
| PTFE | WF-PL-F-0300-20-* | 3 | 69 | 20" | ||
| PTFE | WF-PL-F-0300-30-* | 3 | 69 | 30" | ||
| PTFE | WF-PL-F-0300-40-* | 3 | 69 | 40" | ||
| PTFE | WF-PL-F-1000-5-* | 10 | 69 | 5" | ||
| PTFE | WF-PL-F-1000-10-* | 10 | 69 | 10" | ||
| PTFE | WF-PL-F-1000-20-* | 10 | 69 | 20" | ||
| PTFE | WF-PL-F-1000-30-* | 10 | 69 | 30" | ||
| PTFE | WF-PL-F-1000-40-* | 10 | 69 | 40" | ||
Wechange 0.45 μm PTFE filter membrane is naturally hydrophobic, corrosion-resistant, and resistant to organic solvents, and is easy to clean. It has the characteristics of high flux, low pressure drop, and low precipitation, and is widely used in air filtration and organic solvent filtration in major pharmaceutical companies. 100% integrity testing before leaving the factory to ensure high-quality products.
1.Solvent and strong oxidizing liquid impurity filtration
2.Aseptic air intake and exhaust filtration for fermentation, storage and ingredient tanks
3.Pre filtration of compressed air and nitrogen sterilization
* The absolute pore size ensures effective sterilizing filtration
* Excellent corrosion resistance of organic solvents
* Good chemical compatibility
* The production environment is a 100,000-level clean workshop
* Integrity test for every pleated filter cartridge
* 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 | 5"(127mm),10"(254mm),20"(508mm),30"(762mm) |
Material of Construction:
| Filter Media | Deflector layer | port | Enclosures/Ports | Seals Material |
| PTFE(PTFE) | Polypropylene | Polypropylene | 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≥70 KPa Under 50 KPa,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, Serratia marcescens (ATCC14756) |
| 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 |