ABSTRACT
The isolator also relies on the integrity of its physical structure for maintaining the internal air quality. There seems to be more debate about the leak testing of isolators than any other aspect of their performance, almost on par with the debate about room conditions. First of all, there is the philosophical debate as to whether leak testing is needed at all. Any leakage in a positive-pressure isolator for sterile application will be outward, protecting the product; the converse is true for negative-pressure containment in toxic applications.
