Restricted Access Barrier Systems (RABS) & Isolators: The Perfect Combination of Robot System Safety and Aseptic Drug Manufacturing
نویسنده
چکیده
Industrial manufacturing of injectable drug products presents very different and difficult challenges when compared to other industrial manufacturing applications. In order to enhance patient safety and ensure product quality the Pharmaceutical Industry has been implementing systems called Advanced Aseptic Processing (AAP) systems. Advanced Aseptic Processing systems utilize advanced forms of automation, robotics, machine vision, and separative devices in an effort to protect the pharmaceutical product from contamination. In the pharmaceutical industry these separative devices fall into two categories: Restricted Access Barrier Systems (RABS) and isolators. Although driven by different reasons, Isolator-Barrier Systems and ANSI/RIA R15.06 (Safety Requirements for Industrial Robots and Robot Systems) have the same objective: restrict operator access to the most critical areas of the machinery. A RABS or isolator based robot system, when properly implemented according to ANSI/RIA R15.06 and current Good Manufacturing Practices (cGMP’s), will provide a robot cell that meets the requirements for Advanced Aseptic Processing.
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