Pharmaceutical Technology - May 2022

Pharmaceutical Technology- May 2022

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Page 42 of 63

42 Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK P h a r mTe c h . c o m Aseptic Processing products, such as the Draft EU GMP Annex 1, in Chapter 2 one finds the following information: "The manufacture of sterile products is subject to special requirements in order to minimize the risks of microbial, particulate and pyrogen contamination. The following key areas should be considered: "Facility, equipment and process design should be optimized, qualified and validated according to the relevant sections of the Good Manufacturing Practices (GMP) guide. "The use of appropriate technologies (e.g., Re- stricted Access Barriers Systems (RABS), isola- tors, robotic systems, rapid microbial testing and monitoring systems) should be considered to in- crease the protection of the product from potential extraneous sources of particulate and microbial contamination such as personnel, materials and the surrounding environment and assist in the rapid detection of potential contaminants in the environment and product" (1). The document's mention that "robotic systems should be considered" lends further significance to the issue of robotics in aseptic manufacturing. Development of the first robotics solutions for this purpose has been underway for some time, and there are already fully automated aseptic filling lines with robots and no use of gloves (see Figure 1 as an example). The following considerations are important for their implementation: • Installation of robots to avoid disruptions of first air • Robot movements should involve no particulate or microbiological risks • Automated microbiological monitoring in the isolator • Automated transfer to and from the filling sys- tem without the use of gloves at the isolator • Robust design for isolator and filling system since no manual intervention is possible. Other important factors play a role in using robotics for aseptic manufacturing, such as how microbiological monitoring in the isolator on the filling machine can be automated without the use of agar plates but instead using new technology (e.g., sensor-based microbiological contamination monitoring). Sustainability is a further focus; for example, manufacturers must consider how the packaging of ready-to-use containers, such as sy- ringes or vials, can be simplified with respect to both automation and waste prevention. Sustain- ability and the reduction of carbon footprint will also occupy the pharmaceutical industry in the years to come. Smaller facilities and increased au- tomation can contribute in this regard. The next section of this article describes how robots are and can be used in aseptic manufacturing. Robotics in the pharmaceutical industry In the past decades, robotic technology has gained more significance in the industry. Robots are in- creasingly deployed to take over tasks that are re- Figure 1. A gloveless isolator containing robotic automation (built by SKAN and Groninger) operates as a fully closed aseptic system. Image courtesy of SKAN. FIGURES COURTESY OF THE AUTHORS

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