Reducing the Life Cycle Cost of Validation:
Part 2 – Mold Design, Construction, and Protocols
In Part One of this series, we covered important details you should consider during material selection and part design in order to reduce the life cycle cost of validation. Specifically, avoiding customized materials and staying true to the basic principles of good plastic part design are essential for reducing the life cycle cost of validation. In Part Two, we look at best practices for mold design, mold construction, and development of protocols, as these steps of the process also play a vital role in the long-term costs of validation.
Mold Design And Construction: Be Selective Now to Avoid Issues Later
While the part design for a medical device dictates the plan for manufacturing, the mold design is what truly shapes the end product. If you do not have a well-planned and executed mold design, it is almost guaranteed that you will face struggles down the road, especially if you end up replacing that tool for any reason. So take your time with the design and construction. Be frugal – but not cheap – with material selection and make smart decisions up front to avoid major issues later.