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Boehringer Ingelheim's pharmaceutical R&D building wins Facility of the Year Award for facility integration: building being eyed as a model for R&D sites by major global pharmaceutical companies.

An independent, blue-ribbon panel of judges comprised of global representatives from the pharmaceutical design, construction, and manufacturing sectors declared the new Pharmaceutical R&D building of Boehringer Ingelheim Pharma GmbH & Co. KG, in Biberach, Germany, the winner in the 2008 Facility Integration category in the annual Facility of the Year Awards (FOYA) competition, sponsored by the International Society for Pharmaceutical Engineering (ISPE), INTERPHEX, and Pharmaceutical Processing magazine.

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With headquarters in Germany, Boehringer Ingelheim is a pharmaceuticals researcher, manufacturer and marketer with global operations. The company produces and sells prescription and over-the-counter remedies for a number of therapeutic areas--Spiriva and Atrovent for respiratory ailments, Micardis for high blood pressure, Flomax for enlarged prostate, and HIV/AIDS products Aptivus and Viramune, among others. The company and its worldwide subsidiaries market the popular over-the-counter remedies Zantac and Dulcolax, as well as chemicals and farm and pet medications. Boehringer also offers cold, gastrointestinal, and pain remedies, as well as vaccines and nutritional products.

Synergies Lead To Functional Excellence

When the judges picked Boehringer Ingelheim's pharmaceutical R&D building for the Facility Integration award, it was in recognition that the $67.2 million, almost 9,000 [m.sup.2] site, which houses state-of-the-art formulation laboratories, pilot plants for solids and parenterals, GMP facilities, and offices, was one of the most outstanding examples of "synergistic merging of process and building to create an environment of form and functional excellence."

Dr. Manfred Fiebig, who served as the representative of the user (Boehringer Ingelheim R&D staff who now work in the building) during the planning and execution of the building, says that the rationale for the new facility was to create a versatile space with sufficient capacity to house an increasing number of development projects while promoting the deployment of new cutting edge technologies.

"Prior to the establishment of this facility, the pharmaceutics and process development department was scattered in many different buildings, which were too small and partly too old for appropriate renovations. This, in fact, was a main driver, and it facilitated big picture thinking," he says.

That meant, he explains, the conceptualization of a facility that will incorporate all functions and all disciplines into one building to enhance synergy, optimize communications and promote cooperation. "This has become the largest center for pharmaceutical R&D in Boehringer Ingelheim," says Fiebig.

In their release announcing the winners, the FOYA Award sponsors stated that the Boehringer Ingelheim R&D building was "planned as a development facility" and that "maximum flexibility was of utmost importance to enable handling of a broad diversity of product types, batch sizes, potencies, and dosage forms."

"With a growing number of highly potent active compounds emerging from research, suitable areas were necessary for safe handling without compromising flexibility. Modern and flexible GMP facilities for internationally acceptable manufacture of investigational medicinal products were required to support clinical trials phase I to IV.

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"Both building layout and the concept for technical support systems allow easy adaptation to future needs and the implementation of new technologies," according to the statement announcing the FOYA winners.

Although this is an R&D building, it features a pilot plant that is capable of producing clinical trials supplies for Phase l-IV in accordance with internationally acceptable GMP rules: oral solids and liquids (1kg-200 kg), sterile drugs and parenterals (1kg-300 kg) and highly potent compounds, according to Fiebig.

He explained that detailed design work on the building started in January 2003, following an architectural competition at the end of 2002, and construction was commenced in September 2003. Construction, which lasted 23 months, was completed in July 2005. Commissioning and IQ/OQ was completed in January 2006, and the first products were run on April 11, 2006. "The facility is now fully commissioned and fully operational with all functionalities up and running, says Fiebig.

"The building was designed by us together with outside architects. The main idea was from our company, and we shared those with the architects who further expanded on them to create proposals," says Martina Schleicher, architect and project manager who served as Boehringer Ingelheim's Project Team Leader.

The designer, architectural engineer and general planner for the project was Munich-based Henn Architekten--which also served as the construction manager (responsible for architecture) along with Ottobeuren-based Ingenieurburo Mayer, which handled the domestic engineering. The main general contractor, including HVAC, was Stuttgart-based Axima GmBH, while the piping subcontractors were Lohr GmBH and Ravensburg and Hecht GmBH. Stotz GmbH served as the electrical installation subcontractor while the automation and control supplier was Starkstrom Systeme GmBH.

Schleicher explained that nearly all the equipment and services were provided by regional suppliers. "One major exception was ECOS, the supplier of the cleanroom walls and ceilings, which is based in Austria and which is also nearby," says Schleicher.

"In the beginning there were many visits between us and the architects, and the same is true for all the equipment and component suppliers. Later on several of them moved onsite. When construction began we installed office space for them so that the heads of teams, even from other companies, were located on site," says Schleicher.

"Suppliers generally came to the site when they had to deliver equipment, and we conferred with them in project team meetings but, in general, they did not maintain offices at the site.

"The company has long standing relationships with most of the suppliers, not all. In general, the main factors when selecting suppliers are the cost of the equipment and their proven know how and expertise," says Schleicher.

"Overall, this was a really cost efficient project, perhaps one of our best," says Fiebig. "Martina Schleicher worked closely with the board to justify costs depending on the stage of the project. I believe we were always under the limit, and when the project was finished, it was well within budget," says Fiebig.

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Functional Flexibility Key To Successful Design

The biggest challenges faced by the team revolved around the integration of the numerous functions at the facility. "This is a multipurpose facility that includes as much flexibility as possible, and we had to include functions that would sometimes appear a bit contradictory - such as the development and GMP manufacture of clinical trial supplies.

"One technical feature was that each floor for processing had another floor on top for technical support or maintenance. Our aim was to create the conditions for maintenance to be done outside the processing and GMP area as much as possible.

Also related to this is the layout, which allows all processing rooms to be connected to a technical backbone area. "This means that most of the equipment could be installed in the walls such that the equipment could be accessed from the technical backbone without intruding on the GMP of the processing area," says Fiebig.

The flexibility of the layout also allows for rooms to be changed readily. "The rooms are situated to allow natural daylight in and this provides a pleasant working environment for the workers.

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"There were also efforts to ensure energy saving. The offices were carefully positioned to make use of natural ventilation, such that there would be no energy requirement for air conditioning. In addition, a heat recovery system, installed for the whole building, contributes to energy conservation. In the processing areas we can change the air depending on demand, often based on the kinds of processes being run. Our approach does not use a standard air conditioning system that runs all the time," says Fiebig.

Environmental protection has always been a key issue in the creation and running of the facility. Separate exhaust systems were installed for contaminated air, and installed heat recovery and control systems helped to save energy. Power provided by an in-plant power station equipped with cogeneration assured high efficiency. Waste water was reduced via a canalization system, and the site's own water treatment plant neutralized sewage completely. In the early stages, construction materials were reduced and chosen to be environmentally compatible or recyclable. The separation of waste and recyclable materials is generally performed at the site.

According to Schleicher, "One significant challenge was that we did not have a real benchmark for this project, because Boehringer Ingelheim had not constructed a similar building before, so it would appear there was no internal benchmark.

"It would appear too that there were not many similar buildings within the pharmaceutical industry in other countries as well that integrated this wide a scope of functions."

Fiebig explains that in general the company's research did not identify any project that could be emulated and still fulfill all the requirements for this facility. "All the projects we looked at were either dedicated to solid dosage forms or non-solids or they were more or less for the production of commercial products. "In a true sense, we built something new, a net addition and advancement to pharmaceutical technology," says Fiebig.

Without a doubt, the working conditions for the staff in the new facility improved substantially. "We were scattered around in the old facility and communications between different functions, such as formulations development and scaling up, which are different but must work closely, was not good because they were in different buildings in different areas of the site," says Fiebig.

Sven Schreder, Vice President, Pharmaceutical R&D, whose department consists of more than 150 workers, concurs. "The biggest part of my department, about 130 people, is now located in this building. "The new facility improves and optimizes communications by providing large common areas for staff interaction," he says.

"Technically, we are more flexible and state-of-the-art than ever before. This is an important step forward. Another is the ability to handle high potency compounds. In the past our space was limited and we had few types of equipment for handling high potency compounds. In general, we were seriously constrained by the availability of technology for key tasks," says Schreder.

Schreder says, "This is now one of the most state-of-the-art facilities for R&D. Many other companies have visited us because of their plans to construct similar facilities."

"I would classify the facility as cutting edge particularly in some areas such as the handling of highly potent agents in development areas. This is true not only within Boehringer Ingelheim but when compared with other companies within the pharmaceutical industry," says Fiebig.

He too points to the number of pharmaceutical companies visiting the facility and says, "Other international pharmaceutical companies would like to learn from this facility--this leads to the conclusion that this is not only state-of-the-art but definitely cutting edge as well," says Fiebig.

The Future Looks Bright

Looking to the future, Schreder says, "We now have the capacity to expand our operational activities."

Fiebig says that over the next few years, "We are thinking of bringing in new technologies, and since we have the built in flexibility because we can change the walls quite easily this will not present a major challenge."

Turning to the question of what might have swayed the judges to select the facility for the award, both Fiebig and Schreder readily point to the level of integration in the facility.

Both executives believe that other major contributors include the state-of-the-art GMP facilities, the overall flexibilities built into the site, the establishment of areas for the safe handling of highly potent active materials and the technical concept around HVAC systems that allows cost effective and sustainable operation of the building.

Still, they regard the high level of integration within the facility as the standout. "I think that the integration of all the different functions in combination with the flexibility, without any real benchmark building being available, has to be one of the key contributors to the granting of the award," says Fiebig.

By Bernard Tulsi

Contributing Editor
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Title Annotation:Facility Of The Year Award
Author:Tulsi, Bernard
Publication:Pharmaceutical Processing
Article Type:Company overview
Date:May 1, 2008
Words:1956
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