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High Mycoplasma Retention Capsule Filters & Cartridges - China Suppliers & Factory | Challenge Pore® PES Filters
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]
Max. Operating Temp: 80°C
Max. Operating 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
What are the typical applications for these PES filters?
These filters are typically used for the filtration of cell culture media, intermediate products, drug substances, serum, blood products, and final product filtration.
What is the maximum operating temperature and pressure?
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.
Do the filters comply with biocompatibility and safety standards?
Yes. The filters have an endotoxin level of less than 0.25 EU/mL. They comply with USP <87> for cytotoxicity and USP <88> Class VI biological reactivity requirements for plastics.
How are ChallengePore® PES Capsule Filters sterilized?
They can be sterilized using an autoclave (121°C for 30 minutes, up to 5 cycles) or through Gamma Irradiation (25-40 kGy).
What sterilization methods are compatible with ChallengePore® PES Cartridge Filters?
They can undergo autoclave sterilization (up to 130°C for 30 minutes, up to 25 cycles) and Steam-in-Place (SIP) processing.
How is the integrity of these filters tested?
The integrity of the filters is verified using Bubble Point and Diffusion Flow testing methods.





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