Manufacturers, especially contract manufacturing organizations, have recently faced challenges to provide numerous small inventories to achieve first-to-market penetration. As more products vie for manufacturing space, manufacturers are exploring options for providing a diverse mixture of formulations from their facilities all at once. One potential option is concurrent multi-product ballroom processing. In this processing model, manufacturers […]

By Josh Stewart and Kevin Stout Introduction A commercial drug manufacturer in collaboration with a controls systems integrator recently implemented a stability monitoring enhancement project that required critical environmental data recorded by data-loggers to be stored in a 21 CFR Part 11 compliant manner. The end-user chose instrumentation with the capability to provide data buffering […]