Advanced Aseptic Filling Assembly Helium Integrity Testing

Maintaining the integrity of single-use systems in fill-finish operations is critical to ensuring drug product sterility and quality. Even the smallest breach in an aseptic filling assembly can compromise the final product, which makes leak detection a vital part of the process. Helium leak testing stands out for its exceptional sensitivity, capable of identifying minute leaks that other methods may miss. This level of precision is especially important for single-use assemblies, where sterility cannot be compromised.

Thermo Fisher Scientific’s aseptic filling assemblies are engineered to exceed industry expectations, with helium integrity testing performed at a stringent 10 μm threshold—surpassing the commonly accepted 15 μm standard. This tighter specification not only supports higher product recovery but also reinforces confidence in the sterility of the final drug product.

For teams focused on risk mitigation and regulatory compliance in aseptic processing, gain valuable insights into how helium integrity testing can elevate product assurance.