Barrier isolation technology growing Trend slows in pharmaceutical industry
Myron Struck and Kathleen Vail
Washington, D.C. — The shift toward the use of barrier isolation in developing cleanrooms in the pharmaceutical industry has slowed, with more smaller companies than large moving toward the use of the technology.
Small firms looking to establish an economical system for manufacturing pharmaceuticals are increasingly considering the use of barrier isolation, Michael E. Porter, senior product engineer at Merck & Co. (West Point, PA), says. Among them tend to be companies that deal with biopharmaceuticals and clinical applications. Smaller companies have been taking a quicker lead in the U.S., but the movement in growth remains in Europe.
“There is less apprehension but still a wait-and-see attitude in the U.S.,” says Porter, who was a presenter at the 1998 PDA Annual Meeting held in November in Washington, D.C.
Since barrier isolation systems` popularity began to skyrocket in 1995, only six of 34 manufacturers have earned Food and Drug Administration approval for the systems, with the majority of the systems involving Class 100,000 cleanrooms (55 of 79). Others are in place in Class 10,000 cleanrooms (13) and three each in Class 1,000 and Class 100 cleanrooms. (Five are in unclassified facilities.)
“We need improved transfer technology,” Porter says.
PDA, the 52-year-old international association for pharmaceutical science and technology, featured a seminar on the trends in barrier technology.
“I hear a cry for improved methods for getting materials in and out of the isolator,” Porter says, indicating that enhancing mechanical integration could enhance the growth of the barrier isolation use.
Right now, Porter says, the biggest users of barrier isolator filling lines are Novartis (7 lines), Baxter (5), Pharmacia & Upjohn (5), Eli Lilly (4) and seven companies with three lines (Boehringer Ingelheim, Cilag/Janssen, Evans Medical, ISB, Rhone Poulenc Rorer, Novo Nordisk and Confidential USA).
Jack P. Lysfjord, vice president for technology and international sales at TL Systems (Brooklyn Park, MN), says there is growth in the use of barrier isolation technology because of its lower contamination rate and the likelihood that its use will protect the operator from potent products.
Mimi Riazzi, assistant senior pharmaceutical chemist for Eli Lilly & Co. (Indianapolis, IN), says the challenge is to deal with contamination, biology, materials and location.
In contamination, Riazzi says, the danger is from bacillius stearothermophilus. In materials, glass, stainless steel, hypalon, polyethylene, Teflon, shrink wrapping, Ty-wrap, fiber optic cable, silicone and gaskets can present problems. In setting up the facility, dangers range from temperature distribution to how and where to set up vacuum lines.
Traditionally, Lysfjord points out, barrier isolation was used in the nuclear industry and in microelectronics, with increasing adaptation in pharmaceutical production.
Other growing uses include adapting barrier isolation for sterile pharmaceuticals, including prepackaged syringes and for hydrogen peroxide vapor monitoring.
Growth in the use of isolators has apparently stalled over concern about FDA approval and technology problems.
Generally, transfers of effective technology have been few. And the systems integration approach is still in its infancy, despite more than a decade of growth in the industry.
Still lacking is a solid coordination with software and mechanical systems makers, including the predominant problem associated with stickier glass vials used in testing and manufacturing.
Porter says that with improved environmental monitoring methods and the development of a shorter total cycle time for production, there could be growth.
The FDA has shown a willingness to “engage in discussions on the technology,” Porter says, “and there is an expectation of additional license submissions.”
Myron Struck and Kathleen Vail are freelance writers in Alexandria, VA.