Design of load-lock door for unit dose continuous lyophilization process for complex biologics

Abstract

The process of unit dose continuous lyophilization consists of moving vials containing unit doses of pharmaceutical product though a series of process chambers with varying pressures and temperatures. In order to move the vials between process chambers with varying pressures without disturbing the conditions within each respective chamber, a load lock is required. Although load locks are commonly used in the semiconductor industry, existing designs are not directly applicable to the unit dose continuous lyophilization process due to the unique geometric constraints on the system. This thesis document details the design of a load-lock door for the unit dose continuous lyophilization process. To meet the load-lock door functional requirements, a four-bar linkage load-lock door and a load-lock door with ground pivots offset from the sealing surface were designed. Because the driving performance parameters cannot be reliably modeled, the seal performance, particle generation, and seal adhesion of each design will be experimentally tested. The highest performing design will be chosen and improved based on the experimental results.