The journal cleanroom & processes (Issue 4/2025, German language) has published a new article by Julia Homer (Labor LS) and Dr. Frank Mertens, addressing an often underestimated topic in aseptic manufacturing.
Even intact and validated sterilizing filters may, under certain conditions, allow the passage of microorganisms. These filter-passing bacteria challenge the assumption that the filter itself always represents the final safety barrier.
The publication describes the biological mechanisms behind this phenomenon, presents examples of microorganisms with such characteristics, and outlines strategies for risk assessment and mitigation in aseptic processes.
Its aim is to raise awareness of microbial risks beyond human factors and to strengthen the understanding of contamination control in aseptic manufacturing.
The full article is available upon request. service@labor-ls.de
