By Joshua Russell
The aim of advanced aseptic processing is the elimination and absolute control of all sources of contaminants – most importantly, humangenerated contamination. Robotics and isolator-barrier systems will be the core technologies to advance this initiative further.
The industrial manufacturing of injectable drug products presents very different and difficult challenges when compared with other industrial manufacturing applications. In order to enhance patient safety and ensure product quality, the pharmaceutical industry has been implementing advanced aseptic processing (AAP) systems that utilise advanced forms of automation, robotics, machine vision and separative devices in an effort to protect the pharmaceutical product from contamination. These separative devices fall into two categories: restricted access barrier systems (RABS) and isolators. Although driven by different reasons, isolatorbarrier systems and ANSI/RIA R15.06 (‘Safety requirements for industrial robots and robot systems’) have the same objective: to restrict operator access to the most critical areas of the machinery. A RABS or isolatorbased robot system, when properly implemented according to ANSI/RIA R15.06 and current Good Manufacturing Practices (cGMPs), will provide a robot cell that meets the requirements for AAP.