Tangential Flow Filtration(TFF) System
Jump Pump
FIT Integrity Tester
High Pressure Homogenizers
Microfluidics
0102030405
Challenge Pore® PES Low Protein Binding Hydrophilic Capsule Filters & Cartridges
Superior Compatibility
● Compatible with both Autoclave and Gamma irradiation.
● Highly compatible with a wide range of common solvents used in biopharmaceutical manufacturing.
Pigment-Free Construction
All plastic components, seals, and accessories are pigment-free, minimizing the risk of extractables and leachables (E&L) for a more hygienic process. Fully compliant with USP Class VI and ISO 10993 biocompatibility standards.
100% Integrity Assurance
Through rigorous process controls and stringent factory release testing, we ensure a 100% qualification rate for all outgoing products.
Robust Quality System:
Operating under ISO 9001 and compliant with GMP regulations; Meets stringent testing standards including: Bacterial Endotoxins: USP <85>,Biocompatibility: USP <87> & <88>,Extractables: USP <665>,Free from animal-derived components (TSE/BSE Free).
Validated Excellence：
Products are validated by world-leading agencies such as SGS and NF, ensuring every batch meets international validation standards.
Challenge IM Capsule Filters are specifically designed for the biopharmaceutical industry. They are suitable for applications such as buffer filtration, intermediate product and drug substance filtration, as well as terminal filtration. This product has passed multiple tests conducted by the internationally recognized testing agency: SGS (SGS-CSTC Standards Technical Services Co., Ltd.).
Partial List of Executed Standards
ASTM F838: Standard Test Method for Determining Bacterial Retention of Membrane Filters for Liquids
USP <665>:United States Pharmacopeia: Extractables and Leachables (E&L) Testing in Biopharmaceutical Production
USP <87>: Biological Reactivity Tests, In Vitro.
USP <88>: Biological Reactivity Tests, In Vivo (Class VI)
Product Features
● Unique double-layer design
● Reliable bacterial and particulate retention
● Broad chemical compatibility, pH 1-14
● Extremely low extractables
● Low protein binding
Typical Applications
● Pre-filtration of cell culture media
● Buffer filtration
● Pre-column / Pre-ultrafiltration protection
| 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 |
|
[Filter Dimensions] |
||
|
Disc |
Capsule |
Cartridge |
|
D50: 17 cm² |
01: 0.05 m² |
05: 0.28 m² |
|
|
02: 0.10 m² |
10: 0.55 m² |
|
|
04: 0.20 m² |
20: 1.10 m² |
|
|
05: 0.28 m² |
30: 1.65 m² |
|
|
10: 0.55 m² |
40: 2.20 m² |
|
|
20: 1.10 m² |
|
| [ Materials of Construction ] | ||
|
Filter Type |
Capsule Filter |
Cartridge Filter |
|
Filter Membrane |
Hydrophilic Polyethersulfone (PES) |
Hydrophilic Polyethersulfone (PES) |
|
Core/Cage/End Caps |
Polypropylene（PP） |
Polypropylene（PP） |
|
Capsule Housing |
Polypropylene（PP） |
— |
|
Cartridge O-ring |
— |
Silicone, EPDM, Viton, Encapsulated PTFE |
|
Vent O-ring |
Silicone |
— |
|
Micron Rating |
0.8+0.45μm /1.0+0.65μm/1.0+0.8μm |
|
| 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). |