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Challenge HF® Hollow Fiber Cartridges

Challenge Filair® PTFE High-Retention, High-Flux Hydrophobic Sterilizing-Grade Capsule Filters & Cartridges

Challenge Pore® PES High Mycoplasma Retention Hydrophilic Capsule Filters & Cartridges

Challenge Pore® PES Low Protein Binding Hydrophilic Sterilizing-Grade

Challenge Pore® PES Hydrophilic Capsule Filters & Cartridges

Challenge Pore® PES Low Protein Binding Hydrophilic Capsule Filters & Cartridges

Challenge Pore® PP High-Performance Clarification Capsules & Cartridges

Challenge Filair® PTFE Hydrophobic Sterile Filter with High Retention and High Throughput

Challenge Pore® PES Hydrophilic Filter with High Mycoplasma Retention

Challenge Pore® PES Low-Protein-Binding Hydrophilic Sterile Filter

0102030405

China Challenge Pore® PES Low-Protein-Binding Sterile Filters | Reliable Suppliers & Factory Solutions

The Challenge IM Capsule Filters are a comprehensive solution, encompassing five key series: clarification, pre-filtration & sterilizing-grade, sterile filtration, mycoplasma removal, and gas filtration. With particle retention capabilities ranging from 0.1 to 30 µm, these filters meet the full process requirements for biopharmaceutical applications, from cell culture clarification to final product sterilization. Designed for high-temperature steam sterilization and gamma irradiation, our filters are compatible with a variety of commonly used biopharmaceutical solvents.

All molded parts and sealing components are free of colorants and adhere to Class VI and ISO 10993 biocompatibility standards, significantly minimizing leachables and extractables while ensuring hygienic processing. Each product is subjected to dual integrity testing during production, using two independent methods for stringent quality assurance, guaranteeing a 100% pass rate before leaving our factory.

Our filters comply with ISO 9001 quality management and GMP standards and have successfully passed USP endotoxin, USP / biocompatibility, and USP extractables tests, all without any animal-derived TSE/BSE risk. Manufactured by trusted China suppliers, our products are validated by multiple internationally recognized agencies such as SGS and NF, providing reliable and verified filtration solutions for the entire biopharmaceutical process.

Product Detail

Features

Reliable bacteria and particle retention
Broad chemical compatibility (pH 1-14)
Extremely low leachables
Low protein binding

Typical Application

Prefiltration of cell culture media
Buffer filtration
Pre-column / Pre-ultrafiltration protective filtration
Filtration of serum and blood products
Sterile filtration of final products

Operating Conditions

Maximum operating temperature	80℃
Maximum differential pressure	0.55MPa / 25℃, 0.1MPa / 80℃

Material Construction

Filter Membrane	Hydrophilic Polyethersulfone (PES)
Inner Cage, Outer Cage	Polypropylene (PP)
Capsule Housing	Polypropylene (PP)
Capsule Vent O-Ring	Silicone Rubber
Filtration Accuracy	0.2 + 0.45μm

Biosafety

Endotoxin	＜0.25 EU/mL
Biocompatibility	• Compliant with USP <87> Non-cytotoxic • Meets USP <88> Class VI plastic biocompatibility requirements

Dimension

Disc Filter	D50: 20cm²
Capsule Filter	01: 0.075m² 02: 0.14m² 04: 0.25m² 05: 0.34m² 10: 0.68m²

* Challenge Filair® PTFE filter cable of up to 50 cycles of high-temperature steam sterilization.

Sterilization

Challenge Pore® PES capsule filter cable of be sterilized by high-temperature steam (121 °C for 30 minutes, up to 5 cycles) or by gamma irradiation (25–40 kGy)

0.45μm Pre-Filtration Capsule Filter Flow Rate

Differential Pressure / Flow Rate at 20 °C: (L/min)

Frequently Asked Questions

1. What are the key features of the PES Capsule Filter?

The filter features reliable bacteria and particle retention, broad chemical compatibility (pH 1-14), extremely low leachables, and low protein binding, making it ideal for critical applications.

2. What are the typical applications for this filter?

It is typically used for the prefiltration of cell culture media, buffer filtration, pre-column/pre-ultrafiltration protective filtration, filtration of serum and blood products, and sterile filtration of final products.

3. What are the maximum operating conditions?

The maximum operating temperature is 80℃. The maximum differential pressure it can withstand is 0.55MPa at 25℃ and 0.1MPa at 80℃.

4. What materials are used in its construction?

The filter membrane is made of Hydrophilic Polyethersulfone (PES). The inner/outer cages and the capsule housing are made of Polypropylene (PP), and the capsule vent O-ring is made of Silicone Rubber.

5. Is the filter biosafety certified?

Yes, it has endotoxin levels of <0.25 EU/mL. It is compliant with USP <87> Non-cytotoxic standards and meets the USP <88> Class VI plastic biocompatibility requirements.

6. How can this capsule filter be sterilized?

The Challenge Pore® PES capsule filter can be sterilized using high-temperature steam at 121 °C for 30 minutes (up to 5 cycles) or by gamma irradiation at 25–40 kGy.