Building Barriers

An industry expert discusses his involvement in barrier isolation technology.

Few, if any, people know more about barrier isolation than Jack Lysfjord, vice president of technology and international sales at Bosch Packaging Technology (Minneapolis). He has worked with the technology since its inception and has shared his knowledge and research worldwide. Among his contributions have been helping found the Barrier Users Group (BUGS) of the International Society for Pharmaceutical Engineering (ISPE; Tampa, FL), serving on the ISPE board of directors for four years, and chairing conferences around the world on barrier isolation. In recognition of his accomplishments, ISPE recently gave him the Richard B. Purdy Distinguished Achievement Award for significant contributions to the society. He recently spoke with Senior Editor Erik Swain about barrier isolation’s past, present, and future.

Q: How did you originally get involved with pharmaceutical filling and packaging and barrier technology?

A: I started at TL Systems [eventually acquired by Bosch] in 1981, to set up and manage the Standard Product Division, focusing on vial process equipment for parenterals.

Barrier isolation evolved in the late 1980s and onward in an effort to significantly reduce the particle level and bioburden by removing people from the process equation. The evolution of barrier isolation has kept my interest level.

Q: In all your time involved with pharmaceutical technology, where do you think the greatest advances in pharmaceutical packaging have occurred?

A: Cleanrooms, CGMPs/validation, computers, drug-delivery technology, barrier isolation, blow-fill-seal, containment, label printing on-line, and auto vial inspection.

Q: What do you think are the benefits from working extensively with a group such as ISPE? What would you say have been the best accomplishments of its Barrier Users Group?

A: It is a large, professional, growing, well-managed society. It has provided great opportunities for networking and has been able to enhance the industry’s relationship with FDA.

BUGS had a subgroup, LUMS, which built a prototype production system for vials and did media fills in a machine shop environment. [LUMS stands for a group of purchasers that included Eli Lilly, Upjohn (now Pharmacia), Merck, TL Systems (now Bosch Packaging), Despatch Industries, and Professor Pflug at the University of Minnesota.] The results were shared with FDA in Rockville, MD, in May 1995. This resulted in FDA opening up surrounding-room classification to 100,000, thereby reducing facility costs.

Q: How has barrier technology evolved, and to what extent do you think it has impacted the industry?

A: Initially, it was felt that simply enclosing existing equipment would work. Today, complete integrated barrier isolator systems with validation packages are where it’s at.

Q: Your study with Michael Porter of Merck, which showed barrier isolation systems were more widely in use than previously suspected, received a lot of attention when released. Have they had any subsequent impact?

A: Michael and I are working on another survey, so we have data from 1998, 2000, and will now have 2002. Growth in usage between 1998 and 2000, the number approved by agencies, and growth in Japan are the interesting points. It is particularly of interest how, globally, the industry accepts the technology.

Q: What do you think will be some key developments in the future for barrier isolation?

A: The future will be focused on reducing time from order date to producing product (delivery, validation, and agency approvals) and the addition of containment of potent products. As products increase in potency, containment will also include downstream equipment such as inspection, labeling, and cartoning.

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