Utilizing UV Technology to Develop Medical Devices: An Overview of GMP Conformal Processes and Documentation

摘要

Complex technical processes, used in the production of medical devices, require validation if the results cannot be measured immediately. Examples of such processes are: 1 sterilization, 2 aseptic packaging/assembly, 3 injection molding and 4 UV polymerization of adhesives and varnishes. UV polymerization is widely accepted for its fast and reliable results as well as its relatively uncomplicated installation and operation. It also offers a strong cost/benefit ratio.