An Introduction To Biopharmaceutical Facility Design & Layout

By Herman Bozenhardt, Bozenhardt Consulting Services, and Erich Bozenhardt, IPS-Integrated Project Services

This article is the second in a six-part series on how single-use systems are changing the modern biotechnology facility and process design paradigm.

Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. As described in our previous article, the implementation of single use systems (SUS) is enabling an evolutionary step in the nature of bioprocessing, allowing for a smaller plant footprint and elimination of several common operations. Now, we will discuss how to build a facility around the SUS process technology discussed last month. This article will explore modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance. The next installment will cover design implementations and options.