In the biopharmaceutical industry, liquid filtration plays a vital role in ensuring the sterility and safety of the final drug. Liquid filtration systems are generally used in buffer filtration, bacteria retention filtration, growth medium filtration, stabilizer filtration and other processes. The liquid filtration systems in the biopharmaceutical production process mainly include bioburden reduction filtration systems, sterilizing grade filtration systems and mycoplasma control filtration systems.
1. Bioburden Reduction Liquid Filtration
The bioburden reduction liquid filtration system is mainly to filter non-critical liquids with high contaminant content, such as buffers, washing liquids and other liquids that do not need to meet the requirements of sterility. This can reduce the clogging of the sterile filter system by pollutants in the biopharmaceutical production process and extend its service life. The filtration system generally uses Sanitary SUS316 Cartridge Filter Housings and Hydrophilic PES Pleated Filters or Nylon Pleated Filters of 0.2 micron.
2. Sterilizing Grade Liquid Filtration
Sterilization grade liquid filtration system is mainly used to filter contaminants such as viruses and bacteria in the liquid to ensure the safety and sterility of biopharmaceuticals. Generally used in the production process of monoclonal antibodies, recombinant proteins, vaccines, plasma derivatives, etc. The filtration system generally uses Sanitary SUS316 Cartridge Filter Housings and Hydrophilic PVDF Pleated Filters of 0.2 micron.
3. Mycoplasma Control Liquid Filtration
The mycoplasma control liquid filtration system is mainly installed downstream of the 0.2 micron sterile-grade liquid filtration system. Its role is to enhance the sterility and safety of the biopharmaceutical production process with high pollution risk, and avoid high cost due to mycoplasma contamination during the production process. The filtration system generally uses Sanitary SUS316 Cartridge Filter Housings and Hydrophilic PVDF Pleated Filters of 0.1 micron.
In the production process of biopharmaceuticals, due to the different content of medicines and medicaments and the different hygienic standards of the production process, the design of the filtration system will also be different. Therefore, a suitable filtration scheme should be designed according to the liquid and hygienic standards of the specific process.