Microbial Integrity Of NovaSeptum® Sampling Systems Upon Performance Of Multiple Sampling Actuations

Maintaining sterility during sampling is critical in biomanufacturing, especially when process demands require more than a single sample from the same access point. Examine whether repeated sampling can be performed without increasing contamination risk. Using a rigorous microbial ingress test model, the study evaluates the impact of up to 50 sampling actuations on sterile flow paths under controlled conditions. A highly challenging microorganism is applied externally to stress the system, with results measured across multiple device configurations, needle sizes, and sterilization methods. The findings show no microbial ingress across all tested actuations when components remain undamaged, reinforcing confidence in multi-sample collection strategies.

Access the full application note to review the test design, results, and practical considerations.