Robotics in pharmaceutical manufacturing
“One must understand a process well to perform it successfully, but one must understand a process completely to automate it.” – Chris Procyshyn, CEO, Vanrx Pharmasystems
A central topic of focus for the pharmaceutical manufacturing industry today is robotics. There have been many aseptic fill/finish system upgrades which incorporate robots, however there is only one fully robotic isolated filling system. In 2010, Vanrx CEO Chris Procyshyn ‘wrote the book’ on the use of robotics in pharmaceutical manufacturing. His chapter “Isolated Robotics” in the publication Advanced Aseptic Processing Technology describes the ideal outcome of a digitally controlled, robotic, and flexible filling machine. Eight years after Vanrx’s contribution to the publication, and five years after the commercialization of Vanrx’s SA25 Aseptic Filling Workcell, Vanrx is still the only company with a gloveless robotic isolator on the market. This article will discuss the impact robotics has had on pharmaceutical manufacturing and what it means to be a fully isolated robotic filling system.
Simply putting robots inside a conventional filling system does not make it a robotic system
The purpose of robotics in many industries is to replace humans in performing repetitive or dangerous tasks. The implementation of robotics in pharmaceutical manufacturing is to create a safe, aseptic environment with little to no human intervention. After all, the dirtiest thing in the room is the operator. This is the reality of pharmaceutical manufacturing. However, the industry is only taking half-steps toward utilizing the full potential of robots.
The typical conventional filling system includes conveyors, mouse holes, star wheels, stopper bowls, glove ports, and a considerable amount of human intervention. Each of these elements either create particles, cause interventions, or add considerable risk that needs to be mitigated.
Some filling system manufacturers are now adding robots into their systems. However, these robots are only used for one step of production, such as moving vials from station-to-station or removing the cover from a tub of nested components. This is not a ‘robotic filling system’. It is a filling system with a robot in it. If a robot replaces one unit operation, it only makes a small gain in improving the overall process. This is far from producing the maximum possible improvement in safety or productivity, while also adding cost and complexity.
Furthermore, adding robots to the design of a conventional system is often the result of customer demands rather than manufacturing companies conceiving a full process based on robotics. This can result in a custom, one-off machine.
A fully isolated robotic filling system’s capabilities
The need for new filling technologies arises from current therapeutics in development. Nearly all are targeted towards small patient populations or are new modalities that necessitate creating new manufacturing methods. Therefore, pharmaceutical companies are required to supply targeted drugs to the market quickly and in high quantities.
A fully isolated robotic system is designed as a whole — an integrated system to utilize all robotic capabilities. In setting a design requirement with no glass-to-glass contact and no need for human intervention, the resulting robotic system provides low particle counts and the elimination of glove ports. Since the system is integrated and consistent, it provides a scalable and repeatable process. They are designed for simplicity with minimal moving parts and a streamlined layout. Removing this complexity allows the system to work flawlessly and to experience all benefits of a fully integrated system.
One company, one goal
Vanrx’s fully isolated robotic filling systems provide the adaptability of conventional manual filling, with the quality and precision of the best isolated filling systems. These standardized machines have the programmability to ensure high repeatability and aseptic assurance. Vanrx robotic isolators are designed completely under one roof in Vancouver, Canada, by people who have first-hand experience in developing biologic therapies. The company’s machines are designed by people with a complete understanding of aseptic filling, and therefore can fully automate the process.
The six goals of a fully robotic filling system
In the “Isolated Robotics” chapter of the 2010 publication Advanced Aseptic Processing Technology, Chris hypothesized that six goals would need to be accomplished for a fully robotic filling system to exist. These six goals are explained below with comments on how Vanrx has achieved the majority of them.
|All motion must be digitally controlled and operated, wherever possible||Completely digitally controlled with Industry 4.0 capability.|
|Design a system to fill any conventional vial or syringe||Can fill and close vials, syringes or cartridges.|
|Stopper vials or syringes in line with filling||Ability to quickly stopper containers in sequence|
|Aseptic and/or contained processing||Fully robotic, closed gloveless isolator|
|No aseptic interventions necessary||95% of the origin intervention sources have been designed out of the system. Problems are solved through interactions using robots.|
|No change parts required, other than fill tubing and needle||The Vanrx SA25 does require change parts due to differences between tubs, nests, and container configurations from container & closure differing manufacturers. Vanrx is working to overcome this through Matrix Alliance partnerships .|
What is the future for robotics and Vanrx?
Vanrx was the first manufacturing company to enter the robotic space and to produce a fully isolated robotic filling system. As robotics are defining a new paradigm for manufacturing injectable medicines, Vanrx continues to find ways of automating processes to make the manufacture of new therapeutics more efficient, safer and cost-effective.
“Technologies we develop today will enable the solutions of tomorrow, and given the dramatic improvement in mechatronics technology, it is foreseeable that the future facility will be unmanned” – Chris Procyshyn, CEO, Vanrx Pharmasystems
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Vanrx has contributed to past articles describing robotics in pharmaceutical manufacturing. Read further for more insight from Vanrx.
Chief content editor Karen Langhauser (Twitter: @PharmaMfg)
Vanrx’s CEO, Chris Procyshyn is a recognized expert on aseptic processing and is quoted extensively.
On the personalization of medicine:
“If you look at where we are today with the effects of genomics-based tools and genetics understanding, that’s all having an effect on making much more specific and smaller patient population therapies. And the effect is that we are not all going to take a blockbuster – we are going to take a very specific therapy for our condition, which will most likely be a smaller batch injectable with a higher price tag.”
On aseptic processing equipment standardization versus customization:
“We are talking about an equipment market where ‘custom’ used to be the rule. But today’s drug manufacturers don’t have time to be the guinea pigs for what’s never been tested before. Customers are looking for something that is predictable. At Vanrx, we build very consistent, standardized offerings, and consequently we can develop and refine and test at a very deep level,” says Procyshyn.
On the acceptance of emerging technologies by regulators:
“Ultimately, regulators have the obligation to make sure there is a supply of safe and effective medication. They are pushing for technology advancements. Keep in mind that they see everyone’s filing and everyone’s plant, so they know what best-in-class looks like. Consequently, they push for advances once they see what’s possible.”
Editor Hallie Forcinio (Twitter: @pharmtechgroup) spotlights the reasons why robotics in pharmaceutical manufacturing are increasingly popular, such as eliminating glass-to-glass contact and enabling distributed global production.
Robots not only provide precise, consistent handling, but also offer a high level of flexibility so systems can accommodate a wider range of containers and components with minimal or no change parts. “Flexibility is crucial for high-value, relatively low-volume products,” says Eric Petz, senior marketing manager at Vanrx Pharmasystems. “Batches are smaller, so you can’t have long changeover and startup times.”