Optimizing Process Loads For VHP Decontamination

Takeda GC selected CAI to help rescue a failing Commissioning, Qualification and Validation (CQV) project, focusing on the inefficient Vapourised Hydrogen Peroxide Material Air Lock (VHP MAL) loads. The project was based at Takeda's Advanced Therapy Medicinal Product (ATMP) manufacturing facility (P3), which produces Alofisel. The aim was to create more efficient VHP Loads to enhance operational efficiency. Despite initial challenges, the project was successful, leading to the qualification of five VHP MAL loads that significantly reduced production bottlenecks and costs. As a result, Takeda awarded CAI additional scope, including the qualification of two more VHP MALs and the design and configuration of VHP Production Isolator loads in the P3 expansion project.