In the biopharmaceutical industry, the prevention of microbial contaminants and the control of process related impurities are critical requirements to ensure patient safety, therapeutic efficacy, and regulatory compliance. As processes become more complex and regulatory expectations intensify, Blow-Fill-Seal (BFS) and Single-Use Systems (SUS) technologies are emerging as key solutions to strengthen risk management. By minimizing potential entry points for contaminants and streamlining production flows, these innovations address the industry's demands for robustness, traceability, and responsiveness.