Bidachem SPA is one of the major manufacturers of fine chemicals and active pharmaceutical ingredients (APIs) in Italy. The company became an affiliate of the German pharmaceutical conglomerate Boehringer Ingelheim Group (144 affiliates in 47 countries) in 1982 and since then has been the centre of Boehringer’s Italian operations producing APIs and intermediates for affiliated companies and also third-party customers.
With the operation reaching capacity it was decided in the first quarter of 2007 to expand the production facilities at the plant at Fornovo San Giovanni with the construction of a new API facility on the site.
Fornovo San Giovanni is a municipality in the Province of Bergamo in the Italian region of Lombardy, located in the Gera d’Adda, about 40km east of Milan and about 20km south of Bergamo.
In late September 2007 Jacobs Engineering Group was awarded the contract to provide engineering, procurement, construction management, commissioning, and validation services to Bidachem for the API facility. The investment into the new plant has been estimated at $72m (€51m).
The construction of the facility was completed in May 2009 and the plant was commissioned in July. The project scope includes a new production building dedicated to chemical synthesis, a pilot plant, warehouse, laboratory and support facilities.
Jacobs is expected to execute the work from its offices in Milan. Andy Kremer, Jacobs Group vice president said: “This is a challenging project for Jacobs and we are very pleased to support Boehringer on this strategic Italian investment. They have a reputation for quickly reacting to market requirements and meeting customer demands. This style fits perfectly with our own.”
The Bidachem manufacturing facility in Fornovo San Giovanni has a main production unit consisting of 30 multi-purpose reactors with a combined volume of 107m³ and the associated supporting infrastructure, which occupies a total floor space of 65,000m³.
Production at the plant is ISO 9001 certified and is supported by a state-of-the-art development laboratory and a modest pilot plant for the production of trial quantities of pharmaceutical precursors.
Process equipment at the plant includes 16 × stainless steel multi-purpose reactors 83m³ (1.0-10m³), 13 × glass-lined multi-purpose reactors 26m³ (1-4m³), nine centrifuges, seven filter dryers, nine conventional dryers, one oil heated molecular distillation unit, one high-temperature reactor, two rectifying columns and two crystallisers.
Pilot equipment at the plant includes two stainless steel reactors (0.5m³), two glass-lined reactors (0.13-0.4m³), one centrifuge and one Hastelloy ‘c’ static dryer 0.5m³. Bidachem is a relatively small organisation with a flexible, expandable three-shift-system which is geared to rapid production changeovers. The plant is capable of most kinds of common chemical reactions including bromination but not nitration, pressure hydrogenation and some specialised reactions. Some of these have very specialised safety requirements.
The Bidachem plant is fully compliant with environmental procedures and the company keeps ahead of requirements in environmental protection and safety.
The areas of importance for Bidachem and the environment include: design of clean technologies, reduction in chemical oxygen demand (COD), reduction of air emissions, biological treatment of waste water, post-combustion treatment of emissions, recovery and separation of different types of solid waste. Bidachem, ISO 14001 certified, has recently obtained the OHSAS 18001 certification, achieving the target of total quality management.
Bidachem’s services specifically include custom manufacturing and license production of APIs and intermediates for the pharma-chemicals industry. They can also conduct laboratory trials and scale-up process development in their pilot plant.
The preparation of process documentation and validation protocols for cGMP compliance with regulatory requirements (FDA, MIN.SAN.) under ISO 9001 certification and full regulatory support (DMF, EINECS) is also part of the services they provide. The company is also fully conversant with the preparation of environmental and safety impact statements and submission of these to environmental authorities for consideration.
The new plant, which needed an investment of €60m, was funded from €100m allocated by Boehringer Ingelheim for the development of the Bidachem plant.
Sintesi II has the capability to produce various active ingredients but the emphasis would be on the production of new molecule dabigatran etexilate. Dabigatran, developed by Boehringer Ingelheim, is used in treatment of thromboembolism. Starting with 30t, production of dabigatran in Italy is expected to go up to 100t per annum by 2012. Subsequently, a second active ingredient, flibanserin, will also be produced at the plant.