20th Anniversary Special Feature: Robot remedies for pharma's fraught future

When Bohemian Czech writer Karel Capek penned his play Rossums' Universal Robots in 1921, he couldn't have known that the Czech word for worker would become synonymous with both science fiction and, subsequently, industrial fact.

Robots first became commercially viable in the early 1970, and were principally deployed in rugged and repetitive duties such as welding and handling in automotive manufacturing lines. The first ABB robot, for instance, was installed in 1974 in the automotive field. Since then, more than 150000 have been installed globally — including a large proportion in the pharmaceutical field.

In the pioneering days of robotics in the pharmaceutical sector, the units were largely confined to highly repetitive laboratory tasks, such as the dispensing of sample dosages in clinical applications. Many of these early clinical robots were little more than programmable liquid handlers that provided a mechanical arm for high-throughput screening (HTS) systems, where the arm moved samples from one instrument to another. The industry was slow to adopt robots into manufacturing and packaging processes. One reason for this was, undoubtedly, the industrial nature of robots. Large, apparently oily, machines associated with metal manufacturing processes hardly seemed right for pharmaceuticals.

As the speed and accuracy of robots increased, their mass also reduced. This led to the development of smaller, more flexible machines capable of performing human-like tasks thanks to the ability to incorporate an articulated wrist, finger and thumb. The uptake of robotic automation in other sterile environments, such as food packaging and processing, also gave credence to the possibility of using robots in pharmaceutical packaging and processing.

Robots past

Looking back over 20 years ago, robotics found their way into clinical applications relatively early. Since the mid 1970s relatively simple selective compliant assembly/articulated robot arm (SCARA) robots with two to four axes were able to perform dosing and sampling operations with high repeatability and dosage accuracy. These type of robots remain commonplace in, for instance, blood and DNA testing. Indeed, some experts speculate that the early investment was ultimately costly and unproductive. Thousands of new chemicals were developed, but few were useful.

The advent of clinical standards, traceability and validation processes, such as the first Good Automation Manufacturing Practice (GAMP) and latterly FDA's 21 CFR Part 11, led to further applications of robots to overcome the possibilities of cross-contamination and human error. I doubt there were many, if any, industrial stand-alone robots deployed in the manufacturing processes at that time. Prior to focus shifting towards greater automation — prompted in part by the requirement to remove human error — pharmaceutical processing was on huge scales with little need for the flexibility of programming now required for processing smaller batches of product.

The first robots used outside of the laboratory were used in handling operations, such as end-of-line packaging. Typically, these units consisted of five- or six-axis articulated arm machines for palletizing or bulk packing. As such, they were very similar to their counterparts in engineering industries; although it would be wrong to suggest they were identical, but painted white. In fact there were few differences between robots for end- of-line pharma packing and any other industrial robot.

However, even the earliest robotic developments required machines that could operate in a clean room environment, because the possibility for contamination could not be allowed. Until the development of the all-electric robot (large robots were originally hydraulically powered with potential for oil leaks), clean room machines were impractical. Adapted industrial robots were also incapable of attaining the speeds and accuracies required for high-speed materials handling operations, such as picking and placing products, or even handling primary packages efficiently.

Robots present

What has probably imposed the greatest impetus for using robotic automation within the pharmaceutical sector is the need to reduce costs. Robotics also provide additional benefits including consistent quality, the ability to integrate other functions (e.g., visual inspection) and the ability to govern strict traceability.

Up until 10 years ago, robots were still, predominantly, confined to materials handling and remained downstream of the manufacturing processes. Now, it is much more common to encounter robot automation integrated into mainstream manufacturing lines. For example, with the rise in popularity of blister packs, it is possible to use the latest high-speed, high-accuracy FlexPicker-type delta robots to pick, manipulate and place pills, capsules or tablets into packs. The same robots can also handle the packs — both pre- and post-foil sealing. If flow wrapping or cartooning is included, the robots can still handle the feed placement.

The Future

Robotization of end-of-line packaging systems enables manufacturers to maintain high production rates, while accommodating flexible and varied product packaging requirements. For instance, packaging facilities for blisters and wallets can have many robot cells featuring a variety of different robots.

In many packaging lines, primary packaged products are usually discharged from the packaging process in a single track before being passed on to the secondary packaging process. This is often achieved manually, which can be expensive, or by using conventional methods such as 'side loading' or 'wrap around', which offer little flexibility and take up a great deal of space. As a result, for both ergonomic and economic reasons, robotic systems are very much in demand. The situation is similar in secondary packaging where the trend of replacing manual work with flexible robot systems continues unabated. The use of six-axis machines brings enormous benefits in terms of flexibility and capability to handle varying products — especially when configured in cells rather than lines. The principal benefit of cell type arrangements — apart from floor space savings — is that if any station within the cell requires repair, replacement or maintenance, it does not necessarily affect the other stations in the cell. This means that production can often continue without the need to stop production, as is always the case in linear arrangements.

Many high-volume treatments are manufactured in several countries. When products are sold in millions daily, packaging the tablets for the marketplace can cause a number of headaches. The tablets are often moisture sensitive and must be wrapped in a sealed foil blister pack. Unfortunately, the blisters are often quite large and can be damaged in pockets or handbags. To overcome this, some manufacturers have begun to use wallet packs, where the pack folds over on itself. The interlocking blisters and the outside is protected by a wrap-around card sleeve.

The end result resembles a wallet and protects the tablets while they are being carried. In this case, a computerized, robotized packaging line becomes particularly attractive because of the sheer complexity of the packaging line. Coupled with the fact that these high-volume treatments often have a number of pack variants, at least in terms of quantities of pills, the need for flexibility is of paramount importance. The end result can mean dozens of combinations of blister packs, wallets and shipping cases, which are further complicated by the fact that each one must be identified with a unique barcode. Human processing of the complex variety of pack combinations could slow production or require the opening of extra lines, whereas a typical robot cell might consist of two robots: a small articulated arm machine and a larger carton-forming robot.

The advent of high-accuracy, high-resolution vision technology has added two dimensions to pharmaceutical line automation. Integrating vision into robotic automation enables safe, reliable product and packaging inspection, and there is also the possibility of using this technology for orientating randomly scattered products on conveyors when picking and placing. Such developments have been a huge success in the manufacturing and sterile packaging of medical devices, prefilled syringes and similar products.

FlexPicker-type delta robots can automate the pick-and-place of, for example, flow-packed teat pipette droppers from a conveyor belt (where they arrive scrambled), and then insert each dropper in a carton along with a bottle containing penicillin. This can be done at amazingly high rates. The challenge here is not so much in processing and placing the bottles in cartons, which is not an unusual demand, but in handling the flow-packed dropper, in particular at rates up to 150 items/min. Moreover, the behaviour of the flow packs is variable as some packs adhere perfectly to the product while others swell, which makes them difficult to handle and position correctly for feeding into the cartoning machine. FlexPicker parallel robots solve this problem. The robots pick up the droppers from the belt on which they arrive scrambled, and then the droppers are viewed and identified by a guidance control system with integrated vision.

The system works in several stages that entail the temporary storage of the flow packs in mini-pallets, their subsequent orientation and, only after that, insertion into a cartoning machine.

The solution means the overall layout of a machine takes up less space because delta robots are suspended from the top of the machine and require no work envelope for the 'elbow' to swing out (as is the case with more conventional six-axis machines). Secondly, there are a limited number of critical points and, lastly, a robotized system in the mid- to long-term, guarantees lower maintenance costs and less complex tooling compared with mechanical solutions.

But what really makes the difference is the flexibility. By replacing the end-of-arm-tooling (EOAT) on the robots, they can handle dissimilar products — anything from syringes to spoons instead of droppers.

If in the past, packaging lines were only devised for a single product and format, they now have to be flexible, efficient and adaptable to different products and formats. With these complex demands, robots can give the best answers, as has already been demonstrated in the food and many other industrial sectors.

Robots future

So what scope is there for the future use of robotic automation in the pharmaceutical industry?

Figures from the Robotic Industries Association in the US, published in August 2007, suggest that the future for robotic automation is extremely bright. Sales into the sector during this period climbed by 13% in the —the highest rise of any sector outside the automotive industry (which experienced an unusually strong cycle in the US during 2007). The growth in general automation will be aided by the development of lighter, faster robots with increasing sophistication in relation to vision, sensing and software. This will apply to four-, five- and six-axis machines, as well as to high-speed delta type robots. The design of these machines will specifically address clean room issues and wash down requirements.

Gripper technology will also develop as lightweight high-speed robots attain greater load-carrying capacity, enabling more sophisticated gripper tools at the load point. The ability to incorporate pneumatic, vacuum and mechanical systems within grippers will allow for complex manipulation at very high speeds.

As pharmaceutical packaging becomes more elaborate in an effort to increase security, improve patient convenience and compete on pharmacy shelves, the need for automated assembly of the various components of the package will drive further robot investment. This is already being seen in products such as birth control pills and other medications that are taken regularly, where the packaging can include handy wallet packs along with the conventional blisters and patient instruction leaflets. Such assembly operations are ideal for pick-and-place robotics.

Another trend expected to increase is the development of robot cells rather than linear systems. The cell approach is common in other areas of manufacturing and involves a single multiple-axis robot capable of completing several tasks within the cell. The benefit, apart from floor space reduction and lower costs of automation, are that any one operation in a cell can be maintained independently from the rest — for example, by having dual redundant equipment in the event of an outage on one station. This arrangement is beginning to find favour in pharmaceutical applications and is expected to grow.

There will also undoubtedly be a significant increase in the use of robotic automation in the medical device sector for packaging and materials handling operations. Again, the assembly of packages is a perfect task for robotic automation.

In general, developments in electronics will spur new generations of even more intelligent machines. Servo motion loops (the data communications loop between an input such as a vision system or sensor, the motion controller and the motors themselves) will become tighter, and increased bandwidth will give even faster response times and accuracy. In turn, these developments will lead to improved vision systems and the ability to integrate more data into machine operations, allowing closer control over processes. Simultaneously, software developments will see robots, and automated machinery in general, become even easier to program. Users are already able to control robots via user-friendly programming interfaces, which have been simplified so that engineers familiar with programmable logic controls are also able to program robots. The user interface for every robot is a simple screen and the user can easily implement parameter changes during operation, which significantly increases the quality and efficiency of the system. Simple machine programming can also be used for new product shapes and sizes, as well as the possibility of viewing production statistics.

This open technology is being used more and more by smaller operators. For this reason, there is currently a boom in the use of this technology in stark contrast to the comparatively inflexible proprietary systems. There are also advantages when it comes to service and maintenance as many of the diagnostics and fault finding tasks can be achieved using remote access via the internet and using familiar standard web browser technology.

Conclusions

Robotics have been present in the pharmaceutical industry for more than two decades. Once confined to clinical laboratories, the machines have found their way into the packaging processes and will continue to find new applications throughout the manufacturing arena.

The future is always hard to predict, but it will be determined by technological developments, commercial factors and by changes within the pharmaceutical industry. What is certain is that robotic automation will continue to spread within the sector. Such are the commercial — and financial — pressures globally that, within a relatively short time, those who have failed to invest will struggle to compete.

Bengt Stom is the global segment manager pharmaceuticals for consumer industries at ABB's Robotics Division. He is responsible worldwide for all activities in the consumer industry pharmaceuticals and medical devices segment and drives global objectives through local initiatives. He coordinates activities by identifying and addressing the needs of customers in the sectors. His experience includes working with global pharmaceuticals giants through to small contract manufacturers and copackers. He contributes input from the field to assist new product developments and then communicates those improvements locally and worldwide.

He has worked in the packaging industry for many years, the past 11 of which with ABB. Prior to this, he worked for a packaging machinery manufacturer.