Aseptic filling processes for sterile products not submitted to terminal sterilisation, represent an extremely crucial step during the manufacturing of these products. These processes require – in addition to equipment qualification - in depth validation of the aseptic conditions during filling. Protection of the product is tested by the “media fill” operation, by which liquid nutrient broth is filled in place of the product. The filled units are then incubated and checked for bacterial contamination. In order to minimise the risk of bio contamination, isolator technology offers more secure “clean room conditions” and thus representing an essential improvement for the safety of the process. Valicare – based on long experience in aseptic filling and isolation technology requirements - offers specific support for your validation project, whether the process is under aseptic or under controlled “clean conditions” for terminally sterilised products. Valicare specialises in supporting all qualification phases, based on GMP compliant risk analysis, for the following components of your filling line: