Press Room

Press Release / Apr 12, 2004

Hovione launches new Particle Design technology and state-of-the-art Spray Drying facilities

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.

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 (

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 (

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.

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

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