0102030405
High Mycoplasma Retention Capsule Filters & Cartridges - Double-Layer Design from China Suppliers and Factory
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
What are the primary applications for ChallengePore® PES Filters?
They 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 for these filters?
The maximum operating temperature for ChallengePore® PES filters is 80°C.
What are the differential pressure limits under working conditions?
The maximum operating differential pressure (DP) is 0.55 MPa at 25°C and 0.1 MPa at 80°C.
Do ChallengePore® PES filters meet biological safety standards?
Yes. They comply with USP <87> for no potential cytotoxicity, USP <88> Class VI biological reactivity requirements for plastics, and have endotoxin levels below 0.25 EU/mL.
How can I sterilize the Capsule Filters versus the Cartridge Filters?
Capsule Filters can be autoclaved (121°C, 30 min, 5 cycles) or Gamma Irradiated (25-40 kGy). Cartridge Filters can be autoclaved (up to 130°C, 30 min, 25 cycles) or sterilized via Steam-in-Place (SIP).
Which integrity tests are recommended for these filters?
The recommended integrity testing methods are the Bubble Point and Diffusion Flow tests.





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