Isolaators

Isolaators are enclosed devices that create a controlled environment to protect products from contamination and to shield operators from hazardous materials. They are sealed or semi-sealed chambers that filter the internal atmosphere and can maintain positive or negative pressure relative to the surrounding room. The concept is widely used in aseptic processing, handling of toxic or sensitive materials, and processes requiring strict contamination control.

Isolaators come in several configurations, including glovebox isolators with integrated glove ports for manipulation, and closed or biosafety isolators that maintain aseptic conditions or contain hazardous agents. Some systems include additional features such as inert gas purge (often nitrogen), controlled humidity, and environmental monitoring.

Key components typically include high-efficiency particulate air (HEPA) or ULPA filters, controlled airflows, glove ports, an airlock or entry chamber, and sensors for pressure, temperature, and particle counts. Sterilization and decontamination are integrated through cycles such as chemical agents or vapor-based sterilants, and some models support in-situ sterilization between operations.

Applications span pharmaceutical manufacturing and aseptic compounding, cell culture and virology work, electronic and mechanical assembly requiring air-free environments, and chemical handling involving air-sensitive reagents. Isolaators protect product integrity and worker safety, enabling processes that would be compromised by ambient contamination or exposure.

Maintenance and validation are essential: routine leak testing, filter integrity tests, and formal IQ/OQ/PQ commissioning ensure performance. Standards and guidelines often reference cleanroom classification, validated contamination control, and appropriate biosafety levels.