C&EN, November 13, 2017
Hovione is pleased to announce that it has installed a new state-of-the-art Spray Drying facility to address the latest technology in particle design. The unit, installed at Hovione's API manufacturing plant in Portugal, operates under the most stringent cGMP conditions both as a conventional spray dryer for very fine particles (< 5 - 10µ) and as a fluidized spray dryer for agglomerated, free-flowing dustless materials (100 - 400µ).
Supplied and designed by Niro A/S to the most advanced specifications, this multipurpose unit is capable of evaporating 35 to 90 Kg of water per hour and is equipped with two atomizer systems (a pressure nozzle and co-current two-fluid nozzle). The spray dryer is fit to deliver injectable grade APIs and is configured to be "cleaned-in-place", discharging into a classified clean-room.
The facility allows Hovione to produce dry solids in either powder, granulate or agglomerate form from liquid feedstocks such as solutions, emulsions and pumpable suspensions. This technology enables continuous production, at low-cost and with a high degree of precision over particle design; it allows control of particle size over a wide range of sizes (< 5 to 400µ), as well as control over bulk density and degree of crystallinity. When operating as a fluidized spray dryer, the unit produces free-flowing dustless materials, which are uniform and can be used directly in tableting.
The system meets the most stringent explosion-proof requirements and can therefore spray-dry out of most organic solvents in a safe and compliant environment. It uses nitrogen in a closed cycle as the drying gas thus enhancing its safety and economical production aspects.
The spray drying facility is the result of a close collaboration between Hovione and Niro; the supplier of the equipment has described the unit as one of the most flexible and versatile GMP compliant spray-dryers that they have ever built. Hovione will be presenting its new technology and facility at Biofine in Berlin, on May 5th and 6th, stand nr. E3.
In its programme to expand scientific know-how in advanced technologies, Hovione is actively developing expertise in other particle design techniques:
- Supercritical Crystallization - this technology offers a trouble-free separation of the product from the solvent and the capability to control the size and form of the crystals. The principle is based on replacing a conventional solvent with a supercritical fluid, which may act as a solvent or as an anti-solvent. This technique may be used to produce very small particles with narrow size distribution.
- Ultra Sound Assisted Crystallization- this technology uses ultrasound to influence crystallization behavior by promoting cavitations within the liquid media, which serve as nuclei for new crystals to form. Benefits can include improved crystal habit, purity and the ability to manipulate crystal-size distribution and powder flow characteristics. It also offers a useful and more controllable alternative to seeding.
Hovione is an international group dedicated to the process development and synthesis of APIs (active pharmaceutical ingredients) serving exclusively the pharmaceutical industry. With FDA inspected plants in Europe and the Far East and a Technology Transfer Centre in New Jersey, USA, Hovione is committed to the highest levels of service and quality. Hovione's capabilities include process chemistry, worldwide regulatory affairs, kilo to multi-ton manufacture of complex multi-step chemistry of APIs under FDA and ICH cGMP quality standards.
Note: please be informed that we have photos of the spray dryer available, contact us.