Press Room

Press Release / Oct 08, 2001

Hovione's new Corticosteroid manufacturing facilities

With the commissioning of a 220m2 manufacturing unit dedicated to the synthesis of corticosteroids, Hovione, an independent API manufacturer, widens the range of services offered to the pharmaceutical industry.

Totally renovated in 2001 using state-of-the-art technology, the facility was the object of an FDA PAI inspection in June, for which no Form 483 was issued. The plant is suitable for the manufacture of corticosteroids and similar compounds (but not steroids with hormonal activity) under cGMP for oral, topical, inhalation and injectable administration.

With controlled personnel access as well as controlled materials flow, the unit produces INDs, NDAs and generic compounds in batches ranging from 1 to 100 kilos. Filtration, drying, milling, sieving, micronization and packing are carried out in 3 distinct class 10.000 clean rooms. Tri-clamped lines to transfer the crystallized reaction mixture into clean room conditions for filtration have been installed for speed and flexibility, allowing also for effective cleaning. Charging of solids is done in a closed circuit preventing contact of the product with the exterior through a high containment solids transfer valve. The site is further equipped with WFI and USP purified water loops.

Hovione has 40 years experience in corticosteroid chemistry. The company has expertise in over 75 different analogues and all processes are developed in-house. Hovione´s corticosteroid generic products include betamethasones, beclomethasones, clobetasol, dexamethasone and mometasone.

The new facility dedicated to corticosteroids enhances Hovione's capabilities in the development and manufacture of highly regulated multi-step APIs. Another building suitable for high potency compounds and for cytotoxics is currently under evaluation and design.

Process equipment
Vessels (liters):

  • Glass-lined: 1x 200 – 1x 400 – 1 x 1200 – 1 x 2000 – 1 x 5000
  • Stainless steel: 2 x 2000 – 1 x 7500

Other:

  • Monoplate filters
  • Static bed dryers
  • Micronization equipment
  • Centrifuge
  • Fluid bed dryers
  • Vacuum tray dryers
  • Sieving and Milling
  • Filter-presses

Hovione is an international group dedicated to the synthesis of APIs and serving exclusively the Pharma industry. With FDA inspected plants in Europe and the Far East and sales offices in Hong Kong, Switzerland and New Jersey, 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 standards.

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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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