Managing Risk In Single-Use Systems Design And Implementation

By Hélène Pora

Drug production is a risk-filled process. From research phases to commercial launch, the development of a successful drug product can take a decade or more and requires large investments. Throughout clinical trials and into commercial manufacturing, there is a risk of failure. Because of the level of risk involved in manufacturing drug products, work is done in phases and evaluated along the way. Throughout a process, the risk profile will shift but will always exist, and it will require a clear and effective approach to planning for and overcoming risk.

Today’s market demands more targeted drugs to be produced rapidly and at a lower cost, yet risk remains. Biopharmaceutical manufacturing is tightly regulated. Although total removal of risk is impossible, the goal is to create success based on a complete understanding and mitigation of risks. In addition to local regulatory requirements — which can vary by country — there are a handful of generally accepted regulations.

Ultimate responsibility for drug processes and products always will remain with manufacturers. However, implementation of SUS can shift responsibilities to SUT  suppliers within key areas, including design and sterilization methods that must be controlled and validated. Suppliers such as Pall Biotech know that smart design and automation, data collection, validation, and support services can ensure everyone’s success.