Mold Flow Simulation

A moldmaker said recently that it sometimes takes him up to eight months to validate a large, high-cavity medical mold. Maybe this surprises you, but it doesn’t surprise many OEMs in the medical and automotive industries that have extensive mold qualification and process validation requirements.

Qualifying a mold and validating the molding process in the medical device (FDA requirements) and automotive (Pre-Production Approval Process or PPAP) industries typically requires that the validation process be performed in a specific molding machine that will also be used in production. Usually that means that the moldmaker first qualifies the mold either in-house (if the moldmaker has that capability) or uses an outside molder.