Boehringer Ingelheim is a Germany-based company with interests in pharmaceuticals, biopharmaceuticals, chemicals and animal health products. The company’s main focus is on human health products in its pharmaceutical division and is active across all the major treatment areas including respiratory, cardiovascular, central nervous system (CNS), urological and viral diseases. In addition, the company’s research has now been extended into the immune system, metabolic diseases and oncology.
Because of a growing number of projects in development and also the company’s interest in new technology, Boehringer decided that it needed a new integrated pharmaceutical building with all of the major functions under one roof. The existing development laboratories at Biberach were in several buildings.
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The new 8,859m虏 (95,357ft虏) facility was first planned in 2002. It has been constructed at the Biberach site and includes formulation, process development, scale-up, clinical scale manufacturing and packaging/labelling of products. The building cost around 鈧�44.6m ($64.7m). In 2008 the plant won the Facility of the Year award for the facility integration category.
CONTRACTORS
The new building was constructed at Biberach and is now the largest of across the world. The project management was carried out by Boehringer Ingelheim Pharma GmbH & Co. KG. The architect was Henn Architekten and the general contractor was Axima GmbH, while the domestic engineering for the project was carried out by Ingenieurburo Mayer.
FEATURES
The new building is fully integrated and has a full range of facilities including formulation development laboratories for small-scale experiments developing new compounds for clinical trials. In the same facility there are also pilot plant facilities for scale-up and process development for new pharmaceutical compounds for later clinical trial supplies.
The facility is fully compliant with GMP requirements for manufacture, packaging and labelling and can produce scale-up quantities in batch sizes from 1g to 200kg. The flexible plant has also been equipped to produce and package/label a variety of product types, dosage forms (solids, liquids, parenterals) and potencies.
The state-of-the-art facility has been laid out with an eye on the future with plenty of space; it has a column-free core area for flexible use of rooms and equipment, so that new technology can be incorporated easily. There are also safe areas for the handling of highly potent active compounds.
GMP CONCEPT
The facility was set up in zones with three GMP areas (solids manufacture, sterile areas, packaging) being separated by airlocks from the unregulated areas of the plan. The corridors also act as buffer areas. The processing rooms have adjacent technical areas and cleanrooms with full accessibility for technical installation and maintenance. The cleanrooms are fully modular for ease of rearrangement if required in the future.
The plant handles the full range of early pharmaceutical development and technology transfer and scale-up occurs in the same building, using the same equipment and so saving money and effort. The HVAC (heating, ventilation and air conditioning) systems have full redundancy and were designed along with downflow booth technology to reduce dust exposure so that potent compounds could be handled down to an OEL of 10录 g/m鲁.
There are also two isolator suites for handling highly potent compounds with OEL of > 0.1录 g/m鲁. These two suites are fitted out for GMP manufacture and development in small scale. All of the filter units throughout the facility were designed for dust-free maintenance and exchange.
