This FDA-approved, GMP-compliant lab provides premiere pharmaceutical analytical testing services.
Boston Analytical is a premier Good Manufacturing Practice (cGMP) compliant laboratory. They are registered with the Federal Food and Drug Administration (FDA) and US Drug Enforcement Administration (DEA) for pharmaceutical analytical testing and have International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) certifications. Boston Analytical’s testing services are used by worldwide Pharmaceutical, Biopharmaceutical, and Medical Device companies.
Boston Analytical was in three buildings and multiple units and sought to consolidate and expand their operations. Most of their newly outfitted 30,000 s.f. space is production space for testing: 20,000 s.f. of chemistry, stability, and microbial labs, as well as 2,000 s.f. of ISO 8 to ISO 5 clean rooms. The remaining space supports office and administrative functions, including reception, open and closed offices and conference rooms, and a kitchen/dining area.
Margulies Perruzzi Architects (MPA) performed the programming to determine the spaces that Boston Analytical needed and then designed the new offices. MPA coordinated closely with contractors to provide appropriate space for the specialized mechanical and support systems required to maintain the strict airborne particulate and cleanliness standards, including: high-efficiency particulate air (HEPA); wastewater treatment; and reverse osmosis and deionization (RO/DI) systems.
Adherence to schedule and budget were key as Boston Analytical had to carefully move on a phased basis so that they could conclude work in the existing space and then move to the new space after it was validated and certified for production.