Eternalwater KMT Series
Validation Guide 2inch 4inch PTFE PES Membrane 0.22um Capsule Filters with TC Connection for Medical
Eternalwater KMT series--of capsule filter products cover a variety of specifications and materials and can be applied to bioprocess filtration steps. They meet the requirements of applications from small-scale experiments to large-scale production, with superior filtration performance and reliable sterilization protection.
Applications
Sterile filtration for large and small volume infusions
Sterile filtration for Vaccines, Biologicals and Antibiotics
Sterile filtration for serum and plasma separation
Sterile filtration for cell culture media
Sterile filtration for diagnostic reagents and preparations containing proteins, vitamins and preservatives
Disposable stock solution sterile filtration
Buffer solution filtration
Parameters
| Nominal Size |
2inch |
4inch |
| Outer Diameter |
67mm |
| Total Length |
162mm |
215mm |
| Filtration Area |
1200cm2 |
2400cm2 |
| Housing Material |
PP |
| Center Pole |
PP |
| Support Layer Material |
PP |
| Vent O-ring Material |
Silicone |
| Vent/Drain Outer Diameter |
φ4mm |
| Maxium Operating Differential Pressure |
4bar(58psi) at 25ºC |
| Housing Pressure |
5.5bar(80psi) at 25ºC |
| Sterilization |
can be steriled by Gamma radiation up to 45KGy
can be steriled by high-pressure steam at 126ºC for 30 minutes and 3 times (on-line steam sterilization is not available) |
| Bacterial Endotoxin |
According to the bacterial endotoxin test method stipulated in the general rule (1143) of Chinese Pharmacopoeia 2020 editio, the aqueous extract content is <0.25EU/ml, measured by Limulus reagent (LAL). |
| Microbe Challenge Test |
>10^7 cuf/cm2; according to ASTM® test method passed Pseudomonas diminuta (B.diminuta) ( ATCC® 19146) |
| Biosecurity |
All materials comply with biodafty evaluation of plastic USP <88> Class VI-70°C. |
| TOC/Conductivity |
TOC value≤0.5mg/L, conductivity value≤1.3us/cm. According to the Chinese Pharmacopoeia 2020 Edition, the general rule (0682) the test method of total organic carbon in pharmaceutical water and the general rule (0681) the test method of the conductivity of pharmaceutical water. |
| Cleanliness |
According to the light inspection method stipulated in the general rules (0904) of the Chinese Pharmacopoeia 2020 edition, no fibers and other visible foreign matter were detected in the filtrate. |
| Integrity Test |
Bubble point, diffusion flow, water intrusion;please consult the sales engineer of Eternalwater company for detailed parameters. |
Type Selection Guide
| Membrane Material |
Removal Rating (μm) |
End Cap Type |
Length (inch) |
Sterilized Form |
Packing |
| Hydrophilic PES |
0.05 |
TC50 |
2 |
Resistance to Gamma Radiation Sterilization |
1PCS/BOX |
| Hydrophobic PES |
0.1 |
TC25 |
4 |
Autoclave Only |
|
| Hydrophilic PTFE |
0.2 |
|
|
Sterile Type |
|
| Hydrophobic PTFE |
0.45 |
|
|
|
|
| Hydrophilic PVDF |
0.65 |
|
|
|
|
| Hydrophobic PVDF |
0.8 |
|
|
|
|
| Nylon |
1 |
|
|
|
|
| MCE |
1.2 |
|
|
|
|
| PP |
0.2+0.1 |
|
|
|
|
| |
0.2+0.2 |
|
|
|
|
| |
0.45+0.2 |
|
|
|
|
About Us
Hangzhou Eternalwater Filtration Equipment Co., Ltd. was established in 2011, specilizing in the development of various filter cartridges, filter housings and filters. The products are widely used in pharmaceutical, food and beverage, chemical, electronics and other industries. We adhere to the business philosophy of "customer service, quality first" and are committed to providing customers with filtration, separation and purification solutions. Our company builds workshops in accordance with GMP standards and introduces advanced foreign production and testing equipment. Its production, testing and packaging are all completed in a 100,000-level clean room to ensure that every product can be used with confidence.In the past 12 years, our company has obtained international certification standards such as SGS and ISO, and has become a leader in the filtration product industry.
Certificates
Advantages
- Own factory with 13-year experience in filtration,professional and quality.
- 100% Integrity test before leaving the factory ensures the high quality of products.
- Own labs can do validation and provide relevant test reports.
- Professional technical and service teams
Exhibition
Product Categories
Click on the images to view more products
| High Flow Filter Cartridges |
PP Filter Housings |
|
|
FAQ
1. Q: Are you a trading company or a manufacturer?
A: We are a 13-year professional manufacturer of all kinds of filter cartridges, capsule filters, filter housings.
2. Q: What 's your lead time?
A: Normally 7-20 working days according to your quantity.
3. Q: May I have samples?
A: Sure, of course.
4. Q: What's your MOQ?
A: Normally, 20 PCS/item. Any trial order which is less than MOQ is warmly welcomed.
5. Q: Can you produce according to sample?
A: Yes, we can produce according to your samples or technical drawings.
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