iSpeak Blog

Real-World Sterile Project Case Studies

Hite Baker

As co-chairs of the Barrier Track program at the 2018 ISPE Aseptic Conference, Michael Faia and I built this year’s program around real-world case studies from an all-star line-up of leading sterile manufacturers including: 

  • Biogen
  • Bristol Meyers Squibb
  • Bryllan
  • Fresenius Kabi
  • Genentech
  • Glaxo Smith Kline
  • Pfizer
  • Vetter

This optimized case study format tells eight stories of major, real-world sterile projects by actual owners.  These narrative-style presentations explain project goals, time lines, problems and challenges, and how issues were overcome.  We have maximized the engineering focus in 2018, covering technical issues, problem solving, risk analysis, and lessons learned using numerous pictures, layouts, diagrams, and data.

Highlights of the Barrier Track at the 2018 ISPE Aseptic Conference include sessions focused on:

  • Combo/Flex fillers and RTU components, make-vs-buy
  • Robotic advancements … are gloveless isolators catching on?
  • Legacy facility modernization including 2017 industry poll results
  • Hybrid RABS/Isolators with H2O2 room decontamination
  • Disposables and Technical Transfer
  • Multi product-family facilities to maximize capital assets
  • Update on Annex 1 and Grade A supply/local protection

The 2018 ISPE Aseptic Conference, 6 -7 March in Reston, VA, marks 27 years of providing critical information about engineering solutions and how to provide cost effective facilities which make best use of available modern technology to ensure that products of the highest quality are consistently and reliably manufactured.  The conference educates pharmaceutical manufacturing professionals, especially engineers.

Why attend?  

In two packed days, you will get a panoramic view of what is trending around the world and how leading companies in sterile manufacturing are bringing innovation and advanced aseptic technology on-line.  The 2018 ISPE Aseptic Conference will have a topic of interest for everyone!

I invite you as fellow engineers to check-out this optimized case-study format for the Barrier Track at 2018 ISPE Aseptic Conference.  Stay tuned over the next several weeks, as we continue to share more reasons on why the 2018 ISPE Aseptic Conference is the must-attend conference for aseptic processing. We look forward to seeing you there.

Register Today