Aseptic Filtration

Sterile filtration is to remove microorganisms from liquids or gases by physical retention, and is an important step to ensure the final products sterility. For pharmaceutical products that cannot be ultimately sterilized, a 0.22 µ m sterilizing-grade filter is used as the final filtration, which is a key step to ensure the successful production of aseptic formulations.

The GMP guidelines issued by regulatory agencies require process validation for final aseptic products, requiring that the sterilizing-grade filters be integrity tested to ensure filter performance is verified before and after filter use. The validation items include bacterial retention, chemical compatibility, leachable test, and adsorption evaluation.

Cobetter offer a comprehensive portfolio of sterilizing-grade filters for sterile filtration of liquid. They can be fully scaled up and is suitable for various stages from research and development to production.