Implementing a Material-of-Construction Compatibility Evaluation Program to Support Pharmaceutical Manufacturing

As part of pharmaceutical research, development, and manufacturing, it is critical to assess and select appropriate materials of construction (MOC) for processing equipment to ensure that the chemicals in the process do not degrade the equipment. The earlier any potential MOC compatibility issues are identified, the less likely they are to cause problems in preparing a process for drug manufacturing. In this paper, we discuss the strategy of Merck & Co., Inc., Rahway, NJ, USA (hereinafter “MSD”) for evaluating MOC compatibility, including a testing approach for metals, glass, and plastics, with associated acceptance criteria for general and localized incompatibility. We also summarize our phase-appropriate approach for risk evaluation, which helps ensure that the process transitions smoothly from research through piloting and into commercial manufacture.