|
Combination Device: From Development to Production MPR was approached by a start-up pharmaceutical manufacturer to develop a first-of-a-kind combination device, new sterile filling process, and production facility to manufacture the product. To decrease the device’s time to market, MPR elected to develop both the manufacturing process and the new manufacturing facility simultaneously. MPR individually tested each process step, performed end-to-end process studies, and analyzed each step for its specific functional requirements as part of process development. MPR also performed commissioning and validation of manufacturing equipment, prepared manufacturing procedures, compiled batch production records and provided technical support through initial production. All steps were completed coordinating directly with the client’s engineering, manufacturing and quality assurance departments. MPR was able to meet the client’s aggressive deadline by developing the manufacturing process and constructing the new facility in eighteen months, all while passing rigorous sterility validation tests to ensure the product’s quality, safety, and integrity. |
||||
