MANUFACTURING PROCESSES
Complex manufacturing processes are the core competence of the Fresenius Kabi production unit. Aseptic processing and oxygen-controlled filling; bulk preparation from the simple aqueous solution to complex, repeatedly homogenized emulsions; the processing of a variety of active ingredients; and optimized terminal sterilization mark the range of our capabilities. Fresenius Kabi further invests in complex manufacturing processes with new filling lines equipped with additional technologies such as distillation and ultrafiltration which will allow us to process an even wider range of pharmaceutical compounds with difficult solubility.
Aseptic processing and filling
Aseptic manufacturing is a highly complex and challenging process. To manufacture aseptically means to guarantee product sterility and safety without terminal end sterilization. This puts the highest demands on the manufacturing plant and personnel. Engineering, monitoring, training and housekeeping need to fulfil top standards in order to maintain aseptic cleanroom conditions and to produce aseptic medicinal products with reliable quality.
The manufacturing process includes the sterile filtration of the bulk solution and filling into depyrogenized containers under gas sterilized isolators. Highly trained teams meet the challenging requirements for gowning, personal hygiene and cleanroom behaviour. Continuous microbiological monitoring and regular mediafills prove that the processes meet the requirements. Fresenius Kabi manufactures in accordance with national, European and US regulations.
Oxygen-controlled filling
Oxygen can chemically alter infusion solutions and influence their efficacy and stability. Fresenius Kabi applies complex technology to protect the product with inert gas. Piping and tanks are nitrogen flushed after cleaning and sterilization and kept under constant overpressure. Nitrogen is injected also into the empty bottles and the bulk solution. Before capping the air from the headspace in the bottles is evacuated and nitrogen flushed. This process is repeated until minimal oxygen limits are reached - limits that contribute to product stability.
End sterilization at its most efficient
We process filled units either aseptically or provide terminal sterilization utilizing our autoclaves or steam sterilizers. A great variety of options in the autoclaving programs, both rotating and standing, and in the choice of acceptance criteria between time and F0-value, enables us to adapt the process specifically to the individual products and container forms. This provides maximum security and product sensitivity. To guarantee constant performance our autoclaving programs are re-validated every year.
Packaging technology and container variety
Filling, autoclaving, labelling and packaging equipment is adapted to process a great variety of container types and sizes. Available aseptic and non-aseptic configurations range from the glass vial and bottle over ampoules, various bag solutions to plastic and glass pre-filled syringes. Necksizes, glass types and plastic packaging are processed in European and US standard variations contributing to our proverbial flexibility and ensuring fully customized service.