Romaco Innojet IHD - GMP compliant hot melt device for pharmaceutical applications
Romaco Innojet IHD 5 hot melt device
Romaco Innojet has just come up with the first GMP compliant hot melt coating device specifically for use in the pharmaceutical industry.
The IHD series from Romaco Innojet was
specially designed for coating and granulating pharmaceutical products with hot
greases and waxes. GMP compliance was a key development priority for these CIP
capable devices, particularly regarding the validation of the cleaning processes.
All sealing points, gaps and enclosed spaces were eliminated for this reason
and flange connections reduced to a minimum. The hot melt coating flows through
straight tubes to prevent any build-up of product residues. All
product-contacted surfaces inside the IHD devices are positioned in such a way
that they are fully visible and suitable for swab testing. Once the device has
been cleaned, it can be opened up quickly and easily for inspection. The Romaco
Innojet IHD series successfully avoids cross-contamination thanks to the
hygienic design with no dead spaces.
To allow precise and uniform heat
distribution, the Innojet IHD was designed as a heatable monobloc integrating
all functional components. The melting container, dosing unit and valve block
are all included in the same thermal cycle, which means they 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, so that the coating is applied to the product absolutely
evenly. 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 litres
while the pilot scale machine (Innojet IHD 50) can process up to 50
litres.
Benefits of hot melt coated formulations
Innojet’s
IHD technology lets pharmaceutical manufacturers reap the previously
unattainable benefits of hot melt coatings. Unlike aqueous alternatives, hot
melt coatings contain no solvents which would have to be evaporated again after
they have been sprayed on. Hot melt coatings solidify directly on the product,
resulting in up to 85 percent shorter processing times. Less spray is required
for hot melt coating processes because the formulations are solvent-free.
What’s more, since there is no need to heat the air in order to dry the
product, energy efficiency is improved. Hot melt coating is not only an
extremely economical and efficient production process; it is also very
versatile, for example for moisture barriers, taste masks or delayed API
release.
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