PME 537:Sustainable Design and Operation for FDA Regulated Facilities
Course addresses the sustainable operation and design of facilities and sites subject to regulatory requirements of US federal agencies such as FDA, NIH, OSHA, EPA, DOE and/or applicable international regulators. Course presents timely issues, challenges and potential benefits of implementing sustainable means and methods to meet new Green Codes and Design Standards that are either in draft review or final version for the regulated facility, whether in planning, design, construction or operation phase. Regulated buildings typically have their own unique requirements in their operation, which require special knowledge to comply and or mitigate safety and regulatory issues, while minimizing impact of rising energy costs to manufacturers, saving scarce resources, and protecting the environment. Furthermore, course introduces the students to resources, survey information of latest sustainable/Green thinking in Green Chemistry, Sustainability and Energy Efficient Design and Products to reduce waste, energy consumption, eliminate unnecessary or optimize manufacturing steps, cut operating costs and be environmentally sensitive. Topics include: Global trends in Green Regulations and Design Standards, history of “Sustainable Design,” examples of sustainability in large companies, site selection issues, water resource conservation, architectural issues and material selections, energy resource conservation and efficiency design for mechanical, electrical, and plumbing (MEP) systems in regulated facilities, energy performance of buildings, waste and environmental issues, material resource conservation and efficiency (disposables, packaging), construction techniques toward a sustainable certified facility, sustainable design for cGMP facilities and labs, building operations and maintenance. Course will provide useful, current and practical knowledge of Green and Sustainability Design and operation to individuals who are in or entering a technical career in regulated industries such as pharmaceutical, medical devices, and other sectors that have energy-intensive and regulated facilities.
Michael Perciali, AIA, NCARB, is an Architect Consultant with more than 20 years of professional experience in the architectural field, focusing on design and implementation of construction projects, primarily involved in cGMP facilities for the, BioPharma, Process and Research & Development facilities, Nuclear facilities and other industries. Specific projects encompass biotechnology research and pilot plants, primary manufacturing of active pharmaceutical including potent compounding, sterile fill/finish facilities, secondary manufacturing, clean rooms, bio-safety containment facilities, laboratory buildings, with all the required support functions. He is familiar with the design of high hazard buildings, and knowledgeable of NFPA, FM, NIH, NRC and building codes. His experience includes several major facility projects located throughout North America, Europe, West Africa, Central and South America, and South East Asia
Research & Education
Education
He earned a BS in Architecture from Ion Mincu Architectural Institute, Bucharest, Romania, and a Master of Architecture from Illinois Institute of Technology, Chicago
Experience & Service
Experience
Michael Perciali, AIA, NCARB, is an Architect Consultant with more than 20 years of professional experience in the architectural field, focusing on design and implementation of construction projects, primarily involved in cGMP facilities for the, BioPharma, Process and Research & Development facilities, Nuclear facilities and other industries. Specific projects encompass biotechnology research and pilot plants, primary manufacturing of active pharmaceutical including potent compounding, sterile fill/finish facilities, secondary manufacturing, clean rooms, bio-safety containment facilities, laboratory buildings, with all the required support functions. He is familiar with the design of high hazard buildings, and knowledgeable of NFPA, FM, NIH, NRC and building codes. His experience includes several major facility projects located throughout North America, Europe, West Africa, Central and South America, and South East Asia.
General Information
He is a Registered Architect in NJ, PA, IL, WI, MD, and MI, and is certified by the National Council of Architectural Registration Board
