Author Archives: Marc Hogreve

Ensuring the Integrity of Single-Use Containers: Providing Robustness, Science, and Helium-Based Technology with a Detection Limit of 2 μm

Identifying the greatest defect size, both for liquid leaks and microbial ingress, is a fundamental step toward protecting the integrity of single-use systems (SUS) under real process conditions. Integrity testing of such systems may become a prerequisite in the future because they are used in the most critical process steps, with detection limits correlating to liquid leaks and microbial ingress. Such testing guarantees the sterility of drug substances and drug products packaged in single-use systems and, therefore, enhance patient safety.…

Exploring the Science Behind Single-Use Container–Closure Integrity Assurance

Failures in the integrity of single-use systems during commercial manufacturing can cause a number of serious problems for biomanufacturers. A loss of system integrity during processing can allow environmental contaminants that can be dangerous for patients (e.g., microbes) to enter a process. Biopharmaceuticals and their intermediates can be highly potent or even infectious agents, so an integrity failure can jeopardize the safety of operators. In severe cases when biomanufacturers cannot ensure the quality of drug products for fear of a…