Why Oil-Free Leader Bushings Are Required for Food and Medical Molds

Regulatory Requirements

FDA 21 CFR 177: Any substance that may migrate from the mold to the food-contact surface must be listed as approved. Mold lubricants are generally NOT approved for food contact.

ISO 13485: Medical device molds must have validated cleaning processes for any lubricant. Oil-free bushings eliminate the need for cleaning validation entirely.