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High-Performance PP Clarification Capsules & Cartridges from China Suppliers | Factory-Direct Solutions
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 Challenge IM Capsule Filters compatible with?
They are highly compatible with both Autoclave and Gamma irradiation sterilization methods, as well as a wide range of common solvents used in biopharmaceutical manufacturing.
How does pigment-free construction benefit the filtration process?
By using pigment-free components, seals, and accessories, the risk of extractables and leachables (E&L) is minimized, ensuring a more hygienic process that complies with USP Class VI and ISO 10993 standards.
What quality and regulatory standards do these filters meet?
The filters are manufactured under ISO 9001 and GMP regulations. They meet stringent standards including USP <85> for Bacterial Endotoxins, USP <87> & <88> for Biocompatibility, USP <665> for Extractables, and are completely free from animal-derived components (TSE/BSE Free).
Who validates the performance of Challenge IM Capsule Filters?
Our products undergo rigorous validation by world-leading agencies, including SGS (SGS-CSTC Standards Technical Services Co., Ltd.) and NF, to guarantee compliance with international validation standards.
What are the primary applications for Challenge IM Capsule Filters?
They are designed for buffer filtration, intermediate product and drug substance filtration, terminal filtration, pre-filtration of cell culture media, clarification of fermentation broth, and filtration of serum, blood products, or viscous fluids.
What standard is used to determine the bacterial retention of these filters?
Bacterial retention is tested and determined in accordance with the ASTM F838 standard, which is the standard test method for determining bacterial retention of membrane filters for liquids.