Regulatory aspects of isolation/barrier technology.

This paper represents the best information available to the author at the time of it's preparation, May 1995. The regulatory environment is not static. In late June, the European Union (EU) initiated consultation on the revision to the sterile products annex to the EU GMP directive. Also in June, ISO/TC 198 issued the third committee draft of Aseptic Processing of Health Care Products for a three month ballot. Both documents contain guidance for isolation systems. The reader should be aware that changes are occurring, and be alert for important regulatory developments which may affect the issues outlined in this paper.