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High-Performance PP Clarification Capsules & Cartridges from China Suppliers & Factory - Challenge Pore®
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.
- 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
- Clarification of fermentation broth or cell culture harvest
- Pre-filtration of serum and blood products
- Pre-filtration of colloids or viscous fluids
Frequently Asked Questions
What sterilization methods are these filters compatible with?
The filters offer superior compatibility and are suitable for both Autoclave and Gamma irradiation sterilization processes.
How do pigment-free constructions benefit my process?
All plastic components, seals, and accessories are manufactured without pigments. This design minimizes the risk of extractables and leachables (E&L) to ensure a more hygienic and secure biopharmaceutical process.
What standards do the filters meet for biocompatibility?
Our products are fully compliant with USP Class VI and ISO 10993 biocompatibility standards, specifically meeting testing guidelines under USP <87> (In Vitro) and USP <88> (In Vivo).
How is the quality and integrity of each filter guaranteed?
We ensure a 100% qualification rate for all outgoing products through rigorous process controls and stringent factory release testing. Our manufacturing operations run under ISO 9001 and comply fully with GMP regulations.
Which third-party agencies validate these capsule filters?
Our filters are validated by world-leading testing and certification agencies, including SGS (SGS-CSTC Standards Technical Services Co., Ltd.) and NF, ensuring compliance with international validation standards.
What are the primary applications of Challenge IM Capsule Filters?
They are commonly used in biopharmaceutical processes for the pre-filtration of cell culture media, clarification of fermentation broth or cell culture harvest, pre-filtration of serum and blood products, and pre-filtration of colloids or viscous fluids.





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