Bridging the Gap: Mitigating a Hidden Cleaning Risk in Large-Scale Freeze-Thaw Unit Commissioning: Poster Presented at PDA Week 2026.

During the commissioning and qualification (C&Q) of a new large-scale freeze-thaw unit in a GMP manufacturing environment, a significant cleaning concern was identified involving the bottom shelf assembly. A non-fixed Teflon plate, intended as an insulation layer between the lower shelf and the pressure table, creates a narrow gap prone to fluid accumulation. This area is inaccessible for standard manual cleaning, posing a microbial and cross-contamination risk.The Teflon plate provides an insulation layer between the lower shelf and the pressure table. The current removal process is labor-intensive, requiring a two-person lift to clear internal pins, which introduces ergonomic risks and potential mechanical strain on critical hose connections. To resolve this, we collaborated with the vendor on a design evolution. This presentation details the investigative approach used to identify this "hidden" risk and the subsequent collaboration with the equipment vendor to re-engineer the pin design. Reducing pin length enables horizontal plate removal without lifting the shelf assembly, which successfully bridges the gap between mechanical requirements and GMP cleanability.