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China Suppliers Factory Challenge Pore® PES High Mycoplasma Retention Hydrophilic Capsule Filters & Cartridges
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 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 differential 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 meet biological safety and biocompatibility standards?
Yes. The filters have endotoxin levels of < 0.25 EU/mL and comply with USP <87> (no potential cytotoxicity) as well as USP <88> Class VI Biological Reactivity requirements for plastics.
Which integrity tests are recommended for these filters?
The integrity of these filters can be verified using the Bubble Point and Diffusion Flow tests.
How can ChallengePore® PES Capsule Filters be sterilized?
ChallengePore® PES Capsule Filters can be sterilized via Autoclave (121°C, 30 min, 5 cycles) or Gamma Irradiation (25-40 kGy).
What sterilization methods are suitable for ChallengePore® PES Cartridge Filters?
ChallengePore® PES Cartridge Filters can be sterilized by Autoclave (up to 130°C, 30 min, 25 cycles) and Steam-in-Place (SIP).





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