Creating Technical Debt When Experimenting With 3D Printed Parts

Companies need mature validation paradigms to recognize if and when it's time to transition from a prototype 3D printed part to a sustainable version, likely through a vendor-validated part. In some cases, bespoke parts simply aren't available from vendors. During Bioprocess Online Live: The Risk And Reality Of 3D Printed Parts In Single-Use Workflows, The BioProcess Institute's James Dean Vogel told the story of a company extensively using 3D printers for customized tubing management and other non-product-contact parts. On that note, material understanding, intended use, process controls, and rigorous documentation all play an important part. "The absence of explicit guidance should not be interpreted as the absence of regulatory expectations," panelist Robert Dream said.