Design of Critical Utilities for Biomanufacturing Facilities

Tuesday, April 15 – Friday, April 18 2014
8:30 am – 4:00 pm

This event was posted by Worcester Polytechnic Institute

Location: Worcester Polytechnic Institute


The construction and renovation of biomanufacturing facilities requires an understanding of how biomanufacturing processes need to operate within a facility and within the code and regulations set by the FDA. These include understanding process flow, safety regulations and clean utility requirements to ensure an economic and compliant design and appropriately installed utilities.                  

Construction firms, contractors and design architects wishing to be more successful with their biomanufacturing projects, or those wishing to begin servicing this industry, need to understand the critical regulations governing this industry, and how those regulations may impact the design and construction of utility systems in these facilities.

Key Learning Objectives

  • Biomanufacturing utility sytem design considerations
  • The role of Quality by Design (ICH Q8) in facility design
  • Regulatory expectations - Designing for Compliance
  • Defining the process - CQAs, CPPs, Design Space
  • Equipment and facility considerations
  • “Clean” Utility and Support systems
  • Facility and utility system qualification
  • Risk Assessment (ICH Q9)
  • Project Delivery platform impact

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