The safety and the sterility of the final product is important, and the filtration process must be validated according to regulatory requirement. For sterilizing-grade filter, the process-specific validation is required under the conditions of process time, temperature, product etc. The validation testing includes bacterial challenge test, adsorption test, chemical compatibility test, extractables & leachables test and its safety evaluation.
- ✔ Comprehensive assessment of various influencing factors in sterilizing filtration to confirm the rationality of process conditions, ensuring drug effectiveness and safety.
- ✔ Advanced and comprehensive analytical instruments to achieve comprehensive characterization of extractables and leachables.
- ✔ Professional technical team providing regulatory interpretation, technical support, and validation experiments.
- ✔ Robust quality system to ensure data authenticity, integrity, and traceability.
- ● Full-package of validation testing to make sure the effectiveness and safety of the drug.
- ● Comprehensive E&L profile through advanced analytical instruments
- ● Professional technical team to provide regulatory interpretation, technical support and validation experiment
- ● Good quality assurance to make sure data authenticity, integrity and traceability