0102030405
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
[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 primary applications of these filtration products?
They are designed for cell culture media, intermediate products, drug substances, serum, blood products, and final product filtration.
What is the maximum operating temperature allowed?
The maximum operating temperature is 80°C.
What are the endotoxin levels and biocompatibility standards?
The endotoxin level is < 0.25 EU/mL. Biocompatibility complies with USP <87> (no cytotoxicity) and USP <88> Class VI biological reactivity requirements for plastics.
How can ChallengePore® PES Capsule Filters be sterilized?
Capsule filters can be sterilized using Autoclave (121°C, 30 min, 5 cycles) or Gamma Irradiation (25-40 kGy).
Can ChallengePore® PES Cartridge Filters withstand Steam-in-Place (SIP)?
Yes, Cartridge Filters support Steam-in-Place (SIP) as well as Autoclaving up to 130°C for 30 minutes across 25 cycles.
Which integrity testing methods can be used?
Integrity testing can be performed using standard Bubble Point and Diffusion Flow methods.





Tangential Flow Filtration(TFF) System
Jump Pump
FIT Integrity Tester
High Pressure Homogenizers
Microfluidics