Industry professionals from across the globe gathered in Strasbourg, France for the ISPE Conference on Managing Knowledge through Science and Risk Assessment from September 28 to October 1 at the Palais de Congres. Innovation in isolation technology applications was the focus for the Barrier Isolation Forum, moderated by Charlotte Enghave of NNE Pharmaplan and Jack Lysfjord of Lysfjord Consulting LLC.

Speakers from both equipment companies and drug manufacturers presented the latest in isolator technology and the maturing field of isolator integration of new technologies. Thomas Huber of SKAN presented his analysis of isolator technology adoption and its current growth phase state in the industry, as well as SKAN’s latest product innovations and future plans for development. Roche presented its impressive new Kaiseraugst Parenteral Production Facility, which features multiple isolator and RABS lines with a focus on loss prevention and line efficiency.

Phillipe Fontcuberta presented on the application of e-beam technology in isolated filling operations, and the importance of process variables in the implementation of e-beam systems. Rounding out the presentations from industry, Koji Kawasaki presented on the Japanese perspective in isolator and RABS installations with advanced technologies and integration requirements.

Ian Thrussell of the UK Medicines and Healthcare products Regulatory Agency spoke on his personal experiences in isolator technology from both the manufacturing and regulatory perspectives. Stressing the importance of understanding of the manufacturing process in design of isolator systems, Mr. Thrussell provided discussion on the regulatory implications of improper design and operation of isolator systems, as well as the opportunities and superiority of well thought out systems when compared to conventional cleanroom technology.

Chris Procyshyn of Vanrx presented the launch of the Raptor system and discussed the design approach and philosophy for process integration and adaptability. As isolator technology becomes the standard in aseptic operations, robotic technology is a natural and important accelerating technology enabling risk reduction and efficiency in the modern pharmaceutical facility. Vanrx’s vision-guided robotics systems was demonstrated through video and future steps for the Raptor system discussed.

From this conference and others in 2009, a clear picture of isolator technology being the new and current standard for GMP aseptic operations has emerged. Companies across the globe are successfully employing isolator technology and realizing enormous cost and quality benefits as a result.

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