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.
After the mold is shipped to the OEM or molder that will run production, mold qualification and process validation must be repeated in the press that will be used after the mold is installed in the production molding facility. Because proper validation that conforms to FDA or PPAP standards requires that the mold be validated in the press in which it will run, some OEMs have a protocol that calls for shipping the molding press to the moldmaker (if he or she is capable of performing mold qualification and process validation) or to the molder where the mold will run in production. That ensures that mold qualification and process validation will be done in the same machine that runs production.
However, medical part validation protocols in many cases require re-validation of the molding process and re-qualification of the mold even if the press is moved slightly from its original placement on the production floor. That means the entire qualification and validation process needs to be repeated, a time-consuming and costly event.