GMP-Compliant Hot Melt Device for Pharmaceutical Applications

The Romaco Innojet IHD series have been specially designed for pharmaceutical hot melt coating processes.The system meetsall GMP requirementsand can be supplied as a laboratory or pilot scale machine.

Validation of the cleaning processes has been simplified. All sealing points, gaps, and enclosed spaces were eliminated. Flange connections have been reduced to a minimum. The hot melt coating flows through straight tubes to prevent any build-up of product residues.All product-contacted surfaces are positioned in such a way that they are fully visible, accessible, easily cleaned without disassembling, and suitable for swab testing.

The Innojet IHD was designed as a heatable monobloc integrating all functional components, to ensure precise and uniform heat distribution. The melting container, dosing unit, and valve block are all included in the same thermal cycle, and therefore, do not have to be heated and insulated separately. The compact hot melt coating devices are connected via a trace heated tube to the processing machines in the Romaco Innojet Ventilus series whenever this is required by the application. The Innojet IHD feeds the hot melt with a pulsation-free dosing piston as standard, ensuring that the product particles are coated uniformly. The central bottom spray nozzle on the Innojet machine enables both the temperature and the size of the droplets with which the product particles are coated to be precisely defined. The Romaco Innojet air flow bed technology ensures homogeneous and controllable flow conditions in the container of the processing machines.

The laboratory scale version of the hot melt coating device (Innojet IHD 5) is designed to handle batches of up to 5 L while the pilot scale machine (Innojet IHD 50) can process up to 50 L.

Source: Romaco, Hall 3.0, Booth B49