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China Suppliers Factory Challenge Pore® PES Capsule Filters & Cartridges for High Mycoplasma Retention
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
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 (FAQ)
What are the typical applications for ChallengePore® PES filters?
ChallengePore® PES filters are widely used for the filtration of cell culture media, intermediate products, drug substances, serum, blood products, and final product sterilization.
What are the maximum operating temperature and pressure 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.
Do these filters meet international biological safety standards?
Yes. The filters are non-cytotoxic, complying with USP <87> and USP <88> Class VI Biological Reactivity requirements for plastics. They also feature low endotoxin levels (< 0.25 EU/mL).
How can ChallengePore® PES Capsule Filters be sterilized?
ChallengePore® PES Capsule Filters can be sterilized using an autoclave (121°C, 30 min, 5 cycles) or through Gamma Irradiation (25-40 kGy).
What sterilization options are available for PES Cartridge Filters?
ChallengePore® PES Cartridge Filters support autoclave sterilization up to 130°C (30 min, 25 cycles) as well as Steam-in-Place (SIP) methods.
What integrity tests are used for these filters?
Filter integrity is verified and maintained through standard Bubble Point and Diffusion Flow testing procedures.





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