ABSTRACT
INTRODUCTION Contamination is an important consideration in risk analysis in classical aseptic processing areas. Open processes, which require direct human intervention, represent a greater risk for contamination than closed processes. As a matter of fact, implementation of isolator technology has dramatically reduced the impact of the contaminated surrounding environment upon the critical zone of aseptic processing. Although isolators when properly validated and operated can reduce risk from environmental contamination to a level approaching zero, the transfer of materials (Fig. 1) in and out of an isolator [or other types of separative technologies such as restricted access barrier system (RABS)] represents the most probable reason for the loss of separative enclosure environmental integrity. The more secure the transfer system, the less threatening the external environment becomes, and therefore, results in more effective risk management.
