Musculoskeletal Transplant Foundation

To address MTF’s desire to increase and enhance the production of their tissue products, EI was commissioned to develop, design and build a new tissue processing and sterilization fluid distribution system. The new system is the first of its kind in the tissue bank industry. The process was designed to meet FDA Good Tissue Practices as well as pharmaceutical cGMP guidelines.

As part of the project, EI designed customized processing equipment and sterilization baths. Predefined recipes were programmed into a new PLC system. From bulk storage tanks cleaning and sterilization agents are delivered to clean room baths for washing tissue products prior to packaging, storage and delivery to the medical community.

EI performed the work on a design/build basis and had complete responsibility for fitting the process into the existing facilities in Edison, NJ and Jessup, PA. Our in-house pharmaceutical process design team was responsible for the automated process from initial flow diagrams to P&ID’s and ultimately start-up and validation of the system.