By Robert McIlvaine and Betty Tessien of The McIlvaine Company
Worldwide there are more than 150,000 cleanrooms in use ranging in size from less than 100 square feet to over 300,000 square feet. More than 8,000 new cleanrooms will be built this year, of which the largest 800 will account for more than 80 percent of the total new space. These larger projects are tracked in the McIlvaine publication World Cleanroom Projects. Last month, this column reported on the worldwide cleanroom market for the flat panel display and semiconductor sectors. This month’s column examines the pharmaceutical and biotechnology sectors.
Pharmaceutical and biotechnology companies are actively selecting locations for investment in new facilities and facility expansion in several countries around the world. Bristol-Myers Squibb, which is considering where to build a $660-million facility, has narrowed its choices to Rhode Island, Massachusetts, New York and North Carolina as possible locations. The plant will manufacture viruses, serums and toxins for the diagnosis, treatment and prevention of animal diseases.
The Development Center for Biotechnology (DCB) is the Taiwan government-supported biotech, R&D and development organization. It has a number of responsibilities including linking industry with the academic sector in collaborative research, as well as providing contract R&D and manufacturing services for local biotech companies. The center has opened a cGMP and FDA-approved and -certified biopharmaceutical manufacturing facility, the largest of its kind in Taiwan, with bioreactors up to 500 liters in capacity. The center also operates Taiwan’s largest toxicology facility at its headquarters in Xizhi, outside Taipei.
Roche established the first wholly owned R&D center of any pharmaceutical company in China in October 2005. With three floors and 53,800 square feet of space, the building is set up for approximately 180 scientists and administrative staff members. The facility will focus on chemistry to support next-generation product discovery and development efforts including genomics and genetics research. Over the next three years, Roche hopes to add about 250 employees to the facility.
Meanwhile, Schering-Plough is constructing a large state-of-the-art pharmaceutical manufacturing facility just southwest of Mexico City, utilizing the latest ideas of the “clean core” concept. The factory also had to be designed to overcome intrinsic environmental hurdles such as a nearby volcano and its location in an earthquake-prone area. Clestra supplied the modular cleanroom facilities as well as the HVAC system. Jacobs Engineering was the architect/engineer for the facility. The general contractor was Bufete Industrial S.A. de C.V., a leading Mexican firm. The new three-story plant has 30,000 square feet of space on each floor. Of that, some 20,000 square feet can be built as cleanroom space. Utilities, maintenance areas and other uses account for the remainder of the space. The total cleanroom area is 52,000 square feet-with room for expansion. An ISO Class 8 (Class 100,000) facility throughout, it incorporates modular, enamel-coated steel panels for ceilings and walls, as well as epoxy-coated concrete flooring.
Snyder Langston has been hired by Amgen for preconstruction and general contracting services for a 42,000-square-foot, two-story clinical manufacturing facility in Thousand Oaks, Calif., containing over 15,000 square feet of ISO Class 5 (Class 100) to ISO Class 8 (Class 100,000) cleanroom manufacturing space, plus dedicated administration offices and laboratories. The facility will produce drugs in parenteral and lyophilized forms and fill both vials and syringes for clinical drug trials. It will also produce other dosage forms such as tablets and capsules. Reverse-osmosis water is supplied by a remote central utility plant and is converted into deionized water and water for injection.
Waisman Clinical BioManufacturing Facility in Madison, Wisconsin, conducts basic research through full clinical trials testing in gene- and cell-based human therapeutics. The facility is 10,000 square feet with 6,000 square feet of cleanroom space. It has two suites each for microbial products, cell processing, and mammalian products. Costing $8 million, the facility is one of 14 national centers dedicated to research on human development and developmental disabilities. The center also has an aseptic fill suite, quality control labs and a cell bank. Expansion is being planned as of March 2006, but it will be two or three years before it happens.
The U.S. government is building seven new research facilities that will dramatically expand space for research on currently incurable diseases. One of these facilities is the Center for Disease Control’s new BSL-4 lab in Atlanta. The highest-level-security research space will be 15,000 square feet and cost $214 million. Another highest-level-security facility will be at the Boston University Medical Center in Massachusetts, sponsored by the National Institute of Allergy and Infectious Diseases. The 12,430-square-foot research space will cost $178 million.
The National Institutes of Health has secured $128 million in federal funding for the National Emerging Infectious Diseases Laboratories facility in Boston, where some of the world’s most dangerous pathogens and infectious diseases, such as Ebola and West Nile virus, will be studied. Construction of the 190,000-square-foot lab is expected to be finished in 2008. The new lab will create more than 650 permanent jobs, including 150 for scientific researchers.
Fifteen percent of the Boston facility will be designated Level 4 containment. It will include its own ventilation, electrical, decontamination and waste disposal systems, plus a state-of-the-art security system. All utilities will be backed up by on-site power generation. Security and building automation will allow detailed monitoring of people and space. Air will be HEPA-filtered coming in and will go through two air-cleaning systems on the exhaust side. Solid waste will be subject to heat disinfection before discharge. The facility will be among the most “cautiously designed and constructed…buildings in the world” according to the planners.
Robert McIlvaine is president and founder of the McIlvaine Company in Northfield, IL. The company first published Cleanrooms: World Markets in 1984 and has since continued to publish market and technical information for the cleanroom industry.
Betty Tessien is the cleanroom publications editor for the McIlvaine Company.