ABSTRACT
The rough estimate that 80% of all small-volume injectable and ophthalmic products are aseptically filled has led to a number of innovations designed to increase the level of sterility assurance during aseptic operations. Barrier isolator technology is designed to isolate aseptic operations from personnel and the surrounding environment. Considerable experience has been gained in its use for sterility testing, essentially eliminating false-positive test results. Efforts in adapting automated, large-scale, aseptic filling operations to isolators have steadily gained momentum and will continue to grow in application in sterile product manufacturing (1,2).
