By Brandon Haschke
As Single-Use manufacturing methods continue to take hold throughout the upstream and downstream biopharmaceutical sectors, improved instrumentation options are developing in parallel to meet the unique needs of Single-Use processes while reducing costs and maintaining performance.
Life sciences companies need operational flexibility because it helps them adapt to changing conditions and makes it easier to improve their processes. Oftentimes they may trade flexibility to gain better economies of scale, but they still want to keep their options open, often by using Single-Use technologies.
Traditional biopharmaceutical manufacturing methods are typically designed around stainless-steel equipment such as bioreactor tanks, piping and processing skids. These configurations can be built to any scale, from tabletop laboratory arrangements up to bulk manufacturing sizes. All the associated elements like instrumentation, valves and fittings have been designed for compatibility with these configurations. However, once stainless-steel systems are installed, their geometry constrains their operation, output and throughput to processes, requiring something similar to the original design.
The growing implementation of Single-Use manufacturing methods for upstream vessels and downstream processing equipment addresses these and other issues by providing options for scalability and operational savings, but it also introduces some new requirements. This is especially true with regards to how processes are instrumented and automated. Traditional automated measurement techniques are fixed-in-place just like the conventional equipment they are designed to be connected to, so the instruments and fittings must evolve for use with disposable Single-Use methods.