Planning the Successful BioPharm Facility Modification

Duration: 2.25 hours
ISPE CEUs: 0.2

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As the biopharmaceutical industry has matured and evolved, owners and design service providers increasingly find themselves faced with the task of retrofitting existing operating manufacturing facilities. These projects may be to shore up aging infrastructure and mechanical systems as they near the end of their useful life, to increase throughput capacity, or perhaps re-purpose older facilities as new ones come on line. Limited capital may make retrofitting existing facilities a very viable choice to meet the needs of a product launch or production capacity increase. Others have gone this route to achieve ‘Global Compliance’ from a cGMP/ Regulatory Compliance perspective in order to increase the potential markets for products produced within the facility.

Regardless of the project driver, the technical complexity and level of logistics planning involved with this undertaking can often overwhelm the design team if they are not adequately prepared and armed with the information necessary to achieve their end goal. Add to this the fact that the front-end/ conceptual design and scope of a GMP/regulatory compliant facility needs a logical, step by step approach to the planning and pre-work associated with this uniquely challenging endeavor. Specific direction is given identifying critical information to address regulatory compliance, risk mitigation, and construction logistics planning as well as building code and life safety issues. Potential barriers to success and stumbling blocks are included to eliminate unpleasant surprises during project implementation. A recent retrofit case study is featured.

How You Will Benefit

At the end of this session, participants will be able to:

• Understand retrofit design process considerations
• Explain why a retrofit may be a viable choice rather than new construction
• List the front-end, conceptual considerations that will inform decision-making
• Identify potential barriers

Specific guidance will be given for the following:

• Identifying critical information to be gathered before initiating the design effort
• cGMP/regulatory compliance implications
• Risk mitigation
• Construction logistics planning
• Building code and life safety issues

Technical Documents

• ISPE Baseline® Guide Series

Who Should Attend

Owners/facilities managers, design service providers, engineers, architects, planners, and project managers

ISPE Communities of Practice (COPs)

• Sustainable Facilities
• Project Management (PM)

Session Leader

• Robert Allen, Tech Dir Facilities Integ., Fluor Daniel, USA

Session Speakers

• Santos Herrera, Project Manager, Fluor Enterprises, USA
• Timothy Jackson, Director, C&Q, Fluor Corp, USA
• Ashley Taylor, Exec. Director, Plant, Amgen Inc, USA

Continuing Education Units or CEUs are a way to document time spent in educational programs. ISPE CEUs are calculated as follows: 1 CEU = 10 hours of education time. Thus 0.1 CEU is equal to one hour of education. Download a form to apply for the CEUs for this program.