Pharmaceutical Technology - May 2022

Pharmaceutical Technology- May 2022

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44 Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK P h a r mTe c h . c o m petitive and thus not value adding, which enables operators to focus on key manufacturing processes. Further, the use of such systems also relieves work- ers from hazardous or health-threatening work, such as the handling of highly potent drugs, chem- icals, or heavy loads. Compared to other branches of trade, such as the automotive or semiconductor industries, the pharmaceutical industry falls be- hind when it comes to the deployment of innova- tive robotic technology. Why is this the case? Physical and mechanical requirements that come with the use of robots in pharma include the quality of the surface finish, resistance against common cleaning and decontamination agents (e.g., isopropyl alcohol, hydrogen peroxide), and reduction of particle emissions. A bigger challenge, however, is that pharmaceutical development and production are subject to a highly regulated en- vironment. Many activities include verification, testing, comparison, and calculation procedures. So far, these activities are carried out by skilled and trained personnel. If these are transferred to a machine and thus to a program sequence or an algorithm, good manufacturing practice regula- tions require assurance that the actions are under control, repeatability is given, and all activities are comprehensible and documented. All of these aspects represent a challenge for both the equipment supplier and the customer and, so far, have retarded a speedy implementation of this technology throughout the pharmaceutical indus- try. Now, however, the industry is facing a chang- ing portfolio (e.g., cell and gene therapies, person- alized cancer vaccines), and development of these new therapy types may lead to a different setup of the technical environment, where robots are used to increase the pace of development (e.g., in the analysis of gene sequences). Robotic technology is a driver to speed up pro- cesses and make them safer and more efficient, while lowering cost by reducing the workforce performing repetitive and non-value-added work. It should be considered that the increased use of robots also requires a different set of skills in op- erations. Automation experts are key to an effec- tive application of robotics. Aseptic Processing Scale up Scale out Development Commercial Scale Equipment Development Multiple identical development-scale Equipments Long & expensive Tech Transfer Phase Rapid Tech Transfer due to technical Equivalency Figure 2. Scale-up compared to scale-out as a manufacturing strategy. Figure is courtesy of Markus Stuebchen.

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