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China Suppliers Factory: Challenge Pore® PES Hydrophilic Capsule Filters & Cartridges for Reliable Bacteria Retention
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
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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
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Through rigorous process controls and stringent factory release testing, we ensure a 100% qualification rate for all outgoing products.
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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
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Products are validated by world-leading agencies such as SGS and NF, ensuring every batch meets international validation standards.
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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
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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)
Typical Applications
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Pre-filtration of cell culture media
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Buffer filtration
0.45um Pre-filtration Capsule Filters Flow Rate Performance
Frequently Asked Questions (FAQ)
Are Challenge IM Capsule Filters compatible with autoclave sterilization?
Yes, Challenge IM Capsule Filters feature superior compatibility and are fully compatible with both Autoclave and Gamma irradiation sterilization processes.
What is the benefit of a pigment-free construction?
The pigment-free construction of all plastic components, seals, and accessories minimizes the risk of extractables and leachables (E&L), ensuring a more hygienic process compliant with USP Class VI and ISO 10993 standards.
What quality standards do these capsule filters comply with?
They operate under a robust ISO 9001 and GMP-compliant quality system. They meet USP <85> for Bacterial Endotoxins, USP <87> & <88> for Biocompatibility, USP <665> for Extractables, and are certified TSE/BSE Free.
Which independent agencies have validated these filters?
Challenge IM Capsule Filters are validated by world-leading international testing agencies, including SGS (SGS-CSTC Standards Technical Services Co., Ltd.) and NF.
What are the typical applications for these capsule filters?
They are designed for the biopharmaceutical industry and are typically used for the pre-filtration of cell culture media, buffer filtration, intermediate product and drug substance filtration, as well as terminal filtration.





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