First GMP-compliant hot melt device for pharma applications

4 Apr 2018

The IHD series has been specially designed for coating and granulating pharmaceutical products with hot greases and waxes.

Romaco Innojet has launched the first GMP-compliant hot melt coating device specifically for use in the pharmaceutical industry. The IHD series for processing hot melt coatings can be supplied as a laboratory or pilot-scale machine.

First GMP-compliant hot melt device for pharma applications
Romaco Innojet IHD 5 hot melt device.

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 L whereas the pilot-scale machine (Innojet IHD 50) can process up to 50 L.

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% 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 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.

Read More

Related news

Experts warn trade and patent changes could increase healthcare cost by $100bn over next 5 years

Experts warn trade and patent changes could increase healthcare cost by $100bn over next 5 years

18 Sep 2018

China is harmonizing to ICH standards at feverish pace and will force poor quality manufacturers out of market.

Read more 
Bio processing and manufacturing league table ranks US top and China bottom

Bio processing and manufacturing league table ranks US top and China bottom

3 Sep 2018

US, Germany and Japan revealed as tier one nations in all categories with Sweden ranking the best of the rest.

Read more 
Innovation hindered by regulators

Innovation "hindered by regulators"

27 Aug 2018

CPhI Annual Report expert sees CDMOs as potentially a source of process innovation but warns both regulator and license holders need to move past regulatory diktats.

Read more 
Middle East and Africa pharma economy to reach US$38.8 billion by 2021

Middle East and Africa pharma economy to reach US$38.8 billion by 2021

17 Aug 2018

CPhI Middle East & Africa opens in Abu Dhabi as finished dosage formulations expand quickly, driven by government reforms to further increase local manufacturing.

Read more 
South Korea's finished drug market growth driven by generics

South Korea's finished drug market growth driven by generics

16 Jul 2018

FDF launches at CPhI Korea as country set to become regional hub.

Read more 
CPhI Worldwide opens entries for 15th Annual Pharma Awards

CPhI Worldwide opens entries for 15th Annual Pharma Awards

5 Jul 2018

Winners will be announced live at the Gala Ceremony in Madrid with over 500 of Pharma’s top executives.

Read more 
I Holland woos exhibition visitors with new tabletting technologies

I Holland woos exhibition visitors with new tabletting technologies

28 Jun 2018

Company's Wear Indicator Layer attracts the most attention.

Read more 
Ingredients to improve bioprocess manufacturing efficiency

Ingredients to improve bioprocess manufacturing efficiency

27 Jun 2018

Experts warn bio industry needs to do more to create a sustainable pipeline of talent.

Read more 
Collaboration facilitates continuous manufacturing

Collaboration facilitates continuous manufacturing

14 Jun 2018

Companies working together to help the pharmaceutical industry overcome the different challenges involved in adopting continuous manufacturing.

Read more 
Attendance rise sees CPhI & P-MEC India 2018 move to Indian capital

Attendance rise sees CPhI & P-MEC India 2018 move to Indian capital

12 Jun 2018

The India Expo Mart brings the event closer to Indian regulatory and legislative hub and will encourage international audiences.

Read more