ABSTRACT
What is an Isolator from the Inspector’s Point of View? A section on Isolator technology forms part of the European Union Guide to Good Manufacturing Practice (EU-GMP), Annex 1 (see the text extract that follows) (1). However, no definition of an isolator is provided there or in the Glossary to EU-GMP. Annex 1 addresses the manufacturing of sterile medicinal products, which is of course an important point of emphasis for inspectors. The section detailing isolator applications is not expansive, and provides limited discussion regarding the various types or uses of the technology. This is relevant since another application of the use of isolators is in sterility testing. The EU-GMP has no reference to isolators from this perspective since the process for the undertaking of sterility testing is specified and described in the European Pharmacopoeia (The Harmonized Test for Sterility in Ph.Eur. 2.6.1 contains a very general statement about the testing environment and does not explicitly refer to isolator technology) (2). The different types of isolators are, however, described in other regulatory (or close-to-regulatory) documents such as the FDA Aseptic Processing guidance and the PIC/S Isolation Technology document, where the use of open and closed isolators is described (3,4).
