Trial
The Trial phase ensures solutions realized in the development phase can be reproduced over the long term. The introduction of document controls is a key element of the Trial phase, during which the focus shifts to control and repeatability of production. Purchasing controls ensure the long term availability and quality of raw materials while identification and traceability controls ensure the proper handling of materials throughout the manufacturing process. While much of this work goes on “behind the scenes”, the technical sales representative may provide the client with some newly created documents for their review and approval.
Foster Corporation maintains production and process controls appropriate for precision medical device polymers. These global controls are reviewed jointly by the engineering and production teams to ensure that they meet the specific requirements of the client’s product. Environmental and contamination controls along with inspection metrology are examples of controls that frequently need to be customized for a particular biomedical polymer.
Design and process validation typically take place simultaneously with the fabrication of one or more Trial lots. The technical sales representative and the client work together to determine the number of lots and quantity of medical compound required. During the manufacturing of these lots the production and process controls are tested and the processes are validated. Along with the prototype material, a quality report is provided to the client that contains inspection data and statistical analysis to demonstrate the process validity. The client then utilizes the prototype material in their own processes and reports back to validate the design.
Upon completion of the trial phase, the technical sales representative provides the client a production quote, including unit volume pricing and lead times to be referenced on future production orders.