Meeting Unique Requirements for Facility Design and Production

September 06, 2017

ISPE 2017 Annual Meeting & Expo

The ISPE 2017 Annual Meeting & Expo is fast approaching! As our Chairman, Mike Arnold expressed in his 11 July 2017 Chairman’s Chatter, “This event showcases the latest, successfully employed strategies and technologies that meet today’s growing complexities in the pharmaceutical industry.”  

To keep up with these commitments, the program committee members behind the Facilities and Equipment educational track have selected and organized a series of highly technical sessions emphasizing practices and approaches to solve and/or improve the design, construction, maintenance, and management of biopharmaceutical installations.

This year’s Facilities and Equipment track will enhance your knowledge in these core areas: 

1. Facilities of the Future

  • Create and map out a program to properly apply the basis and structures to significantly improve cost of ownership and life cycle of capital projects.
  • Understand the advantages of utilizing novel modeling techniques, simulation and animation to enhance operation and efficiencies in lab research facilities.
  • Learn the key issues of Levels of Protection in an OSD facility, and the risk-based elements associated with modern facility layout and HVAC design.
  • Explore, understand, and apply principles and practices to meet full potential to reduce quality risks, project delivery time, and improve operational performance and reliability while satisfying regulatory expectations.

2. Facilities Maintenance

  • Review the design and operation fundamentals of new and legacy sterile manufacturing facilities.
  • Discover how to best achieve flexible solutions to deliver pipelines and ensure supply to patients.
  • How existing facilities can be streamlined to increase production with limited investment.
  • Explore challenges and approaches for project owners, designers, and contractors to balance cost, quality, and schedule for accelerated project delivery.

3. International Facilities

  • Review Amgen’s 10-year process to develop their biotechnology manufacturing platform from large scale stainless steel processing to a next generation all disposable single use manufacturing facility in Singapore.
  • Learn how KUBio, a turn-key solution, its design focusing on single-use manufacturing and optimizing the facility function around manufacturing efficiency, speed to market and reproducibility. Real life experience by JHL Biotech in Wuhan (China).

4. Biotech Facilities

  • Analyze how a design and construction project driven by speed to market and cost of goods and quality of product, will benefit by an integrated project delivery approach where the owner, engineer and constructor are aligned and committed to design-in proven modular construction 
  • Understand the range of current options available, and the trade-offs associated with flexibility, schedule, cost, labor location, and other factors when selecting the delivery approach and facility type/technology applying to manufacturing technology.
  • Learn how Biogen designed and constructed a new fast track oligonucleotide manufacturing facility to support clinical and small scale commercial manufacturing.

5. Facilities Management

  • Identify all the resources and process touch points needed to meet project goals to shorten timeline to market delivery in the biopharmaceutical industry.

6. Sustainability/Critical Utilities

  • Explore how sustainability is key to the future pharmaceutical facilities; benefits of dynamic simulation and modeling to maximize the engineering solutions of facilities throughout the world.
  • Learn how the pharmaceutical industry must implement water conservation programs for economic and social reasons. 
  • Understand how to properly sample pharmaceutical water systems and reduce the potential false positive or negative sampling results.

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By: Michelle M. Gonzalez
Engineering Director (Retired) AMGEN, Inc., 
BioPharm Engineering Consultant
Facilities and Equipment Track Director