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China Suppliers Factory: Challenge Pore® PES Hydrophilic Capsule Filters & Cartridges for Bacteria Retention and High Flow Rates
Superior Compatibility
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Compatible with both Autoclave and Gamma irradiation.
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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).
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.).
Typical Applications
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Pre-filtration of cell culture media
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Buffer filtration
Partial List of Executed Standards
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ASTM F838: Standard Test Method for Determining Bacterial Retention of Membrane Filters for Liquids
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USP <665>: United States Pharmacopeia: Extractables and Leachables (E&L) Testing in Biopharmaceutical Production
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USP <87>: Biological Reactivity Tests, In Vitro.
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USP <88>: Biological Reactivity Tests, In Vivo (Class VI)
0.45um Pre-filtration Capsule Filters Flow Rate Performance
Frequently Asked Questions
What sterilization methods are compatible with these capsule filters?
These capsule filters feature superior compatibility and are fully compatible with both Autoclave and Gamma irradiation sterilization processes.
Are these filters free from pigments and animal-derived components?
Yes, they feature a pigment-free construction for all plastic components, seals, and accessories to minimize the risk of extractables and leachables (E&L). They are also certified free from animal-derived components (TSE/BSE Free).
Which biocompatibility and quality standards do these products meet?
The filters are fully compliant with USP Class VI, ISO 10993, and operate under an ISO 9001 quality system compliant with GMP regulations. They meet stringent testing standards including USP <85> (Bacterial Endotoxins), USP <87> & <88> (Biocompatibility), and USP <665> (Extractables).
How is the quality and integrity of the capsule filters assured?
We implement rigorous process controls and stringent factory release testing to ensure a 100% integrity qualification rate for all outgoing products.
What are the typical applications for these capsule filters?
They are specifically designed for the biopharmaceutical industry and are ideal for applications such as pre-filtration of cell culture media, buffer filtration, intermediate product and drug substance filtration, as well as terminal filtration.
Which third-party agencies validate these filters?
Our products are validated by world-leading independent testing agencies, including SGS (SGS-CSTC Standards Technical Services Co., Ltd.) and NF, ensuring compliance with international validation standards.





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