Baccinex specializes in the manufacture of liquid or lyophilized sterile products by aseptic filling. Nevertheless, terminal sterilization can also be carried out.
Generic media fills are periodically performed according to GMP in order to validate the process of aseptic manufacturing. Nonetheless, in case of atypical production process, complementary media fill tests have to be realized in order to guarantee aseptic manufacturing conditions.
Training of operators is a critical issue to guarantee an aseptic process. Therefore strict standardized procedures are rigorously applied to the training of personnel working in grade A clean rooms.
Manufacturing capacities of liquid products are detailed under: Manufacturing