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Challenge Pore® PES 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)
Typical Applications
● Pre-filtration of cell culture media
● Buffer filtration
0.45um Pre-filtration Capsule
Filters Flow Rate Performance
| Working Conditions | |
| Max. Operating Temp | 80°C |
| Max. Operating DP | 0.55 MPa @ 25°C 0.1 MPa @ 80°C |
|
[Filter Dimensions] |
||
|
Disc |
Capsule |
Cartridge |
|
D50: 17 cm² |
01: 0.06m² |
05: 0.33 m² |
|
|
02: 0.12 m² |
10: 0.66 m² |
|
|
04: 0.23 m² |
20: 1.32 m² |
|
|
05: 0.33 m² |
30: 1.98 m² |
|
|
10: 0.66 m² |
40: 2.64 m² |
|
|
20: 1.32 m² |
|
| [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 |
| [ 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 |
0.45μm /0.65μm/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). |