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Challenge Pore® PES High Mycoplasma Retention Hydrophilic Capsule Filters & Cartridges - China Suppliers & Factory with Double-Layer Design
Typical Applications
Filtration of cell culture media
Intermediate product and drug substance filtration
Filtration of serum and blood products
Final product filtration
Product Specifications
| Working Conditions | Standard Operating Limits |
| Max. Temp | 80°C |
| Max. DP | 0.55 MPa @ 25°C 0.1 MPa @ 80°C |
Biological Safety
| Endotoxin | < 0.25 EU/mL |
| Biocompatibility | Complies with USP <87>, No potential cytotoxicity. Complies with USP <88> Class VI Biological Reactivity requirements for plastics. |
| Integrity Test | Bubble Point and Diffusion Flow |
Sterilization Methods
ChallengePore® PES Capsule Filters
Autoclave (121°C, 30 min, 5 cycles) or Gamma Irradiation (25-40 kGy).
ChallengePore® PES Cartridge Filters
Autoclave (up to 130°C, 30 min, 25 cycles) and Steam-in-Place (SIP).
Frequently Asked Questions
1. What are the typical applications for ChallengePore® PES Filters?
ChallengePore® PES filters are designed for critical filtration processes, including cell culture media, intermediate product and drug substance filtration, serum and blood products, and final product sterilization.
2. What are the maximum operating pressure and temperature limits?
The maximum operating temperature is 80°C. The maximum operating differential pressure (DP) is 0.55 MPa at 25°C and 0.1 MPa at 80°C.
3. How is the biological safety of these PES filters verified?
They are certified safe with endotoxin levels under 0.25 EU/mL. They fully comply with USP <87> for cytotoxicity testing and meet USP <88> Class VI Biological Reactivity requirements for plastics.
4. How can I sterilize ChallengePore® PES Capsule Filters?
PES Capsule Filters can be sterilized using an autoclave at 121°C for 30 minutes (up to 5 cycles) or through Gamma Irradiation within the range of 25-40 kGy.
5. Can ChallengePore® PES Cartridge Filters withstand Steam-in-Place (SIP)?
Yes, the cartridge filters are designed to withstand Steam-in-Place (SIP) thermal cycles, as well as autoclaving up to 130°C for 30 minutes for up to 25 cycles.
6. What integrity tests are recommended for these filters?
To ensure reliable filtration performance and membrane integrity, both Bubble Point and Diffusion Flow tests can be performed.





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