Creating Flexibility And Efficiency In Isolator-Based Filling With Robotics And Automation

Fill-finish is a critical part of biopharmaceutical manufacture, any mistakes at this point can lead to the product being mis-formulated, contaminated, or improperly packaged which in turn leads to safety issues, production failures and ultimately, the loss of viable product just as it advances to its most valuable point of production. At this stage of manufacture, robust, trusted processes are required to manage any risk to operations.

Operator involvement is closely tied with sterility assurance. The more involved operators are in the filling process, the more likely sterility assurance failures may occur. While operator involvement is sometimes necessary, it unfortunately creates a larger risk of contamination. Isolator-based filling removes operators from the filling environment thereby decreasing opportunities for sterility assurance failures. The increased sterility assurance offered by isolators is reason for why they are preferred in the drug production process.

In this article, Shawn Kinney, CEO of Berkshire Sterile Manufacturing (BSM), explores the development of isolator-based filling systems and the improvements in technology over the last few decades, the introduction of robotics and technology and presents a case study for the optimal solution for sterile, isolator-based filling.