Downstream Sampling Process Optimization

Abstract

The Downstream Sampling Process in the Biopharmaceutical industry is a timely and product consuming step. This process can be described as a highly labor intense due to all the required steps to collect a sample. In order to optimize the sampling process is important to maintain the product sample attributes. For this case these attributes were; pH conductivity, endotoxin and bioburden. The main objective of this project was the optimization of the product sampling process based on samples reduction, sterilization, and reducing the risk of product contamination by applying a six sigma methodology. PR Biotechnology Solutions Company challenged the capability of two inprocess sampling devices (MN and GSD). Finally, experiments results, showed that both sampling devices MN and GSD are capable to collect the in process samples from process tank without affecting the established process parameters or compromising the sterility of the sample. Key Terms – Downstream, Optimization, Product, Sampling.