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Equipment and Processing Report
The pharmaceutical industry has a history of developing innovative medicines and novel drug-delivery systems, but not all of its manufacturing processes use cutting-edge technologies. Demands to increase productivity in fill–finish lines are fueling the arguments of proponents of robotic automation to expedite manufacturing.
Innovation plays an important role in the pharmaceutical industry, including in manufacturing. Robotics is one area that offers opportunity for further advancement in areas such as fill–finish production.
In terms of accuracy and speed, robots far exceed what the pharmaceutical industry requires. But, for a long time, robots did not meet the industry’s requirements for aseptic manufacturing. Operators could not decontaminate robots with hydrogen peroxide in a way that could be validated. In addition, robots shed particles at unacceptable levels and often were made of materials, such as aluminum, that were not suitable for filling operations. But these problems have since been overcome, and technological advances are no longer necessary for drugmakers to implement robots. “They can do it today,” says Chris Procyshyn, CEO of VanRx Pharmasystems.
Many firms are trying to increase their flexibility to adapt to evolving patient needs and new products. Robots’ key advantage is that they can provide this flexibility, says Josh Russell, principal engineer in life sciences at Automated Systems of Tacoma. The vast majority of traditional filling machinery is dedicated to a specific container format, such as syringes, vials, or cartridges, and this design limits its capability. But robots integrated within an isolator–barrier system can fill–finish various container formats aseptically on a single modular system, says Russell. Robotic systems can minimize the operational and financial requirements for expanding filling capabilities and also enable facilities to be smaller and leaner.
Robotic filling systems also can help maximize equipment uptime because companies can change them over rapidly to another batch or product, regardless of container format, says Russell. Reconfiguring robotic systems requires few change parts, few process changes, and minor, if any, manual adjustments, unlike the changeover process for traditional filling systems. Robotic systems’ auto-adjust functionality manages production parameters and eliminates the need for operators to adjust the system manually.
To some observers, regulators seem to understand the advantages that robots can provide. “I don’t believe the regulators are standing in the way,” says Procyshyn. “If you come back to the regulators and say, ‘I can achieve a six-log decontamination. I operate at ISO 5 for particles, and I completed all of my validation media fills (and have the appropriate data to support this),’ the response from the agency is going to be, ‘OK. Sounds good to us.’”
“The future of aseptic manufacturing may come to rely heavily on robotic systems,” says Joerg Zimmermann, director of process development and implementation at Vetter Pharma-Fertigung. “Drugmakers are slowly abandoning the idea of discovering blockbusters and filling millions of units. Today’s clinical pipelines include many products that are highly specific to particular patients or patient subpopulations. These products will call for smaller batch sizes in production and more changeovers. Flexibility will become paramount, and robots will help manufacturers achieve it,” he says.
The regulatory atmosphere, current technology, and the characteristics of developing pharmaceutical products seem to favor industry’s adoption of robots for aseptic filling. “I don’t hear anyone saying that they don’t think robots are the future,” says Procyshyn. “The questions are how, where, and who, but it’s coming, for sure.”