We have established and implemented cleaning validation programs at two clients in the US, one in Switzerland, one in Curacao, and we have supported several others. Our engineers have the ability to generate cleaning matrixes, assess clean-ability, recommend cleaning agents, and develop the associated documentation to confirm that your process is in compliance. Our risk based calculations are based on the Lilly Calculation, which is the industry standard model for assessing residue risks.
Our engineers have worked with plant engineers to validate several manufacturing processes: bioreactor processes, chemical manufacturing, aseptic filling, and finishing processes. In keeping with the industry, we use a more rigorous and scientifically based process validation which takes into account the risks inherent in the processes. We work to provide a more robust level of data to ensure that your processes are under control and remain in control. The collection of more data allows for better understanding of the process which then allows for more flexibility in the parameters.