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China Suppliers Factory Challenge Pore® PES Low Protein Binding 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)
Product Features
Unique double-layer design
Reliable bacterial and particulate retention
Broad chemical compatibility, pH 1-14
Extremely low extractables
Low protein binding
Typical Applications
Pre-filtration of cell culture media
Buffer filtration
Pre-column / Pre-ultrafiltration protection
Frequently Asked Questions (FAQ)
Q1: Are Challenge IM Capsule Filters compatible with common sterilization methods?
A1: Yes, they are fully compatible with both Autoclave sterilization and Gamma irradiation methods, offering flexible integration into various bioprocess workflows.
Q2: How does the pigment-free construction benefit biopharmaceutical manufacturing?
A2: By using pigment-free components, seals, and accessories, the filters minimize the risk of extractables and leachables (E&L), ensuring a highly hygienic process that complies with USP Class VI and ISO 10993.
Q3: What quality standards do these capsule filters conform to?
A3: Our production operates under ISO 9001 and GMP regulations. The products meet standards such as USP <85> (Bacterial Endotoxins), USP <87> & <88> (Biocompatibility), USP <665> (Extractables), and are certified TSE/BSE Free.
Q4: Have these filters been validated by independent testing agencies?
A4: Yes, Challenge IM Capsule Filters are validated by world-leading third-party testing agencies, including SGS (SGS-CSTC Standards Technical Services) and NF, ensuring compliance with international validation guidelines.
Q5: What are the main applications for Challenge IM Capsule Filters?
A5: They are ideal for cell culture media pre-filtration, buffer filtration, intermediate and drug substance filtration, terminal filtration, and pre-column/pre-ultrafiltration protection.
Q6: What is the chemical compatibility range of these filters?
A6: These filters offer broad chemical compatibility across a wide pH range of 1 to 14, making them suitable for handling diverse solvents and aggressive chemicals used in bioprocessing.