Reducing The Life Cycle Cost Of Validation (Part 3): Equipment Selection, Processing, And Maintenance

By Kyle Kulwicki, PTI Engineered Plastics, Inc.

Selecting the most appropriate material and having a well-planned mold design, as discussed in Part 1 and Part 2 of this series, are essential pieces of establishing the long-term success and longevity of your medical device validation. However, without the right equipment, you cannot determine the dependability and repeatability needed to ensure a high level of quality and production uptime required for the lifetime of your product’s production needs. In the final installment, we will discuss how to select your equipment correctly, ensure it can consistently function as needed, and what you need to do to maintain its performance day after day.