Case Study: Build out of a new state-of-the-art aseptic isolator manufacturing facility

Edward Connolly

Case study will highlight the ups and downs of a 3+ year process to build out an isolated aseptic manufacturing facility. •Selection process for key equipment and facility design. •Insight into vender selection •Forming partnerships with vendors •What to expect during the isolated filling line, FAT and install •Regulatory strategy for product transfer to a new line/facility