Do Sterility Test Isolators Need To Be So Complicated?

By Gary Partington

A good example of how simple isolators have been made complicated can be found in sterility test isolators. Isolators have been around the pharmaceutical industry since the early 1980s and in the nuclear industry (glovebox technology) since the 1950s. Isolators are used to create an airtight barrier or enclosure around a piece of equipment or process to provide absolute separation between the operator and product. The operator can perform tasks through half-suits or glove ports. Isolators provide a specific environment inside the isolator using HEPA filters. The environment can be positive pressure or negative, can have humidity control, oxygen control, use unidirectional airflow, and can either protect the product from the operator (as with aseptic processes) or protect the operator from the product (as with potent product handling).