The validification for mold qualification and manufacturing process are equally important for user. Intertech can do both of them good and quick, contact us now !

The validification for mold qualification and manufacturing process are equally

important for user.  Intertech can do both of them good and quick, contact us now !

How to streamline plastic injection mold qualification and process validation

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.

sourced from : https://www.plasticstoday.com/injection-molding/how-streamline-plastic-injection-mold-

qualification-and-process-validation/21779763857805