EMCM-product-3353-klein

Process development at EMCM for a medical aesthetic

Our client increased the forecast of the product 2 fold on short notice. To successfully pull off the execution, EMCM played a significant role in designing, testing and implementing an upscaled production process which could cater to the increased demand primarily by targeting 3 areas: Increasing the yield /batch, reducing the risk of contamination & reducing manual operations. The production is executed in an aseptic environment, by incorporating a closed system (bulk production). The scope of the project also included supporting the processes development with the relevant regulatory and qualification documentation and filing changes in the product dossier. EMCM‘s knowledge of aseptic manufacturing processes, ability to quickly respond to change in demand, project management – from design, testing, implementation and approvals at notified body played a significant role in catering to the increased demand on short notice.