Practical Considerations For Aseptic Gowning In Contamination Control Strategies (CCS)

In the manufacture of sterile medicinal products, personnel remain the most significant contributor to contamination risk. Human presence introduces a constant stream of skin cells, hair, and clothing fibers into the cleanroom, with nearly 10% of these airborne particles carrying viable microorganisms. This reality necessitates a rigorous Contamination Control Strategy (CCS) that moves beyond simple checklists to address the complex interactions between operators and their environment.

A truly effective CCS, as outlined by EU GMP Annex 1, requires a detailed analysis of every personnel-related factor—from the ergonomics of the gowning room to the nuances of aseptic technique during interventions. By evaluating these risks through a structured lens, manufacturers can implement practical mitigation measures that safeguard product integrity without compromising operational flow. Explore these practical considerations further to refine your facility’s approach to sterility assurance.