The Impact of Automation on Aseptic Processing - Pharmaceutical Technology

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The Impact of Automation on Aseptic Processing
The authors review the role of automation in aseptic processing and describe their experience in implementing advanced technologies, including the use of isolators and robotics.


Pharmaceutical Technology


Both machine automation and robotics play central roles in the operation of this production line. The depyrogenation tunnel has push-button setup and fully automatic sterilization of the cooling zone. It also has an automatic vial-counting system to ensure that each row of glass entering the tunnel is carefully arranged and introduced without crashing the vials into the previously loaded row. This automated feature reduces the likelihood of vial breakage.

The filling system has two weight-control features. The first is an automated mass flowmeter filling system in which all fill data are digitized and electronically stored. The second system is a gravimetric weight-check system that uses load cells to take empty and filled vial weights. The gravimetric weight-check data are also digitized and stored electronically. Both systems automatically alarm and reject out-of-specification containers. Actual fill-weight accuracies attained with the mass flow system are measured within 0.5% of the target.

The rubber-stopper supply system is fully automatic and uses the first VPHP-compatible robots installed and validated in the world. One such robot unloads sterilized containers of rubber stoppers from the autoclave, while a second robot lifts these cans and replenishes the load of stoppers in the feed hopper when signaled to do so by a level sensor. Thus, human operators are not involved in transporting containers of stoppers nor do they play any role in the feeding of stoppers into the feed hoppers.

Like the previously described vial line installed in the United States, the Handai-Biken system has fully automated lyophilizer loading and unloading. In this case however, the loading system is not only fully automatic, it is also VPHP decontaminated and operates within an isolator enclosure. This filling line is an excellent example of the marriage of machine automation and robotics with modern isolator technology. The use of isolators and VPHP decontamination requires that all components be resistant to long-term exposure to H2O2.

Conclusion

This article provides only a glimpse into the history of automation in aseptic processing and its development during the past three decades (8). Although our experience is extensive, we realize that there are many other examples of the use of automation in aseptic processing and the marriage of automation with modern separative environments such as isolators. We do not see the evolution in aseptic technology described in this article coming to an end; rather we believe it will follow an accelerating trajectory onward and upward. The future of aseptic technology lies in the continued implementation of automation with the ultimate goal being the complete elimination of interventions altogether. We have glimpsed this future with the design and installation of high speed "interventionless" aseptic processing systems operating at throughputs as high as 1200 containers/min.

Robotics continue to evolve as well, and VPHP-compatible six-axis robots are being designed for cytotherapy products among other potential production, research, and testing applications. These robots can be operated either under full electronic programmed control, or by humans controlling them by remote control devices called "Manipens." Current software allows the operator to quite literally train the robot to perform a specific task. These robots can interface well with single-use technologies (disposables) and are well-suited for aseptic compounding operations as well.

The future of automation and robotics in aseptic processing is an exciting one. Thousands of industrial robots are undertaking a wide range of manufacturing tasks in facilities throughout the world. Our industry has actually been relatively slow to adopt robots, but we believe change is underway and that the future of aseptic processing is one in which human contamination is no longer a risk (9).

Yoshi Izumi is executive vice-president at Shibuya Hoppmann Co., a subsidiary of Shibuya Kogyo, Co. Ltd. James E. Akers* is president of Akers Kennedy Associates and technical consultant to Shibuya Kogyo, Co. Ltd.,

*To whom all correspondence should be addressed.


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