WORKING IN ISOLATION

摘要

Isolator technology has come a long way in recent years, and there is no sign that the flow of innovations is drying up. Progress is being driven to a large extent by the pharmaceutical sector - the continuing growth of biological medicines and the development of increasingly potent active ingredients (HPAPIs). In both cases operator safety and drug quality are of paramount importance. In the UK, the Health and Safety Executive (HSE) and the Medicines and Healthcare products Regulatory Authority (MHRA) issued updated guidance on factors to consider when selecting either negative or positive pressure isolators for the aseptic reconstitution of cytotoxic drugs. The guidance is aimed at NHS pharmacies and licensed contractors, and updates the version published in 2003 following the input from key stakeholders.