FUNDAMIX® System for Insulin Production

Insulin must be mixed thoroughly for accurate dosing, but it aggregates and loses activity under mechanical stress. This application paper explains how the FUNDAMIX® Vibro-Mixer resolves that conflict in insulin manufacturing. It outlines the process from fermentation to dosage preparation and shows why the mixing steps before vial filling are critical for product quality. Instead of a rotating impeller, an oscillating plate creates intensive circulation with low shear and no baffles, keeping the solution homogeneous without damaging the protein. The paper also covers the design features that regulated production depends on: a membrane sealing unit that isolates the sterile medium under pressure and vacuum, without a mechanical seal, low plate positioning for effective mixing at reduced fill levels, and CIP/SIP compatibility of all product-contact parts, following cGMP and EHEDG principles. Examples of skid-mounted systems with integrated CIP/SIP units show typical installations.