Bengt Stom

When Bohemian Czech writer Karel Capek penned his play 

 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.  

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.  

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. 

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. 

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. 

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.  

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. 

Articles

Robotization of end-of-line packaging systems enables manufacturers to maintain high production rates while accommodating flexible and varied product packaging requirements.

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

Never has greater pressure been applied to pharmaceutical manufacturers. Shelf space competition for branded drugs has reached aggressive proportions and now even prescription drugs vie for pricing and delivery. Against this is a backdrop of ever-increasing downward price pressures, and a spectrum of progressively more stringent legislative and quality requirements. Finally, regional markets now demand different tamper evidence technology, anticounterfeiting measures and safeguards against interference by biological terrorists. Much of which points to the need for innovation in packaging — not just in terms of pack styles and sizes, but also cost. 

All pharmaceutical companies, whether they are large multinationals making branded products, producers of generics, contract manufacturers or co-packers, face the same downward price pressures. The industry has never been so competitive and, in spite of rising demand and emerging markets, costs remain a primary driver in manufacturing investment — particularly in packaging. Paradoxically, against these price pressures, the demand for quality, traceability, validation and tamper evident packaging all potentially conspire against the manufacturers that are trying to reduce costs. 

Coupled with these factors, most pharmaceutical companies also face the challenge of increasing costs through to ongoing globalization, and the growing importance of product differentiation for primary and secondary packaging. This necessitates new levels of efficiency, cost-effectiveness and flexibility within the packaging process. In addition, packaging methods must be integrated within the entire supply chain — there has to be an interface with the preceding drug manufacturing steps, as well as the warehouse and distribution steps that follow.  

Furthermore, the packaging must guarantee product stability within a specified time frame and ensure safe, secure storage and transport until final use. It must also satisfy its function as a marketing and communication device and, finally, there is the increased importance of patient convenience alongside child resistance, tamper evidence and protection against counterfeiting. 

New packaging styles and formats bring about fresh challenges for integration, system validation and security measures — including not just tamper evidence, but also patient information leaflets, and track and trace data (such as barcodes and RFID tags).

The net result of these pressures is that pharmaceutical companies must now carefully examine their production methods, costs and flexibility. Manufacturing processes are largely governed by the laws of chemistry and present few opportunities for savings achieved from efficiency or efficacy improvements. At the end of the line, however, there remains scope for investment that can yield dividends; not just in economies and cost reductions, but also by introducing commercial differentiators such as pack sizes, types and styles. 

Many analysts in the industry suggest there will never again be blockbuster drugs. Even if this sweeping statement is not entirely founded, it does highlight the unequivocal shift towards greater competition and variety in pharmaceutical products. Moreover, this is a trend that shows no sign of abating. To satisfy the changing market needs for variety and flexibility, the industry might perhaps look at its high volume, high variety counterparts in the food sector. 

Customer-specific and innovative packaging designs are gaining importance, while the variety of products is increasing and batch sizes are shrinking. Hence, there is increasing demand for intelligent, versatile packaging systems that can handle a multiplicity of different products safely, quickly and cost-efficiently at the end of the production line. 

Modern packaging machinery can accommodate all sorts of programmable flexibility; in blister packing, wrapping, cartoning and secondary packing, but it is the handling and in-line quality control where challenges remain.

In addition to saving space and costs, robots can also ensure the required precision and reliability of packaging operations. Easy robot programmability is the key to enabling minimum resetting times when the plant is set to new products or packages, but also the combination of advanced software, diagnostics and modern machine vision systems can integrate the entire process through packaging lines. The benefits of a truly effective, amalgamative approach to automation are the overall reliability and profitability of the resultant system, and the ability for systems to share common control platforms. This enables electronic signaturing, foreshortened and cheaper validation because of common hardware and software platforms, simplified and cheaper maintenance, and even shared risk on the output and uptime of the lines. 

Robots have been used in the packaging industry since the late 1970s, originally to handle heavy goods in the palletizing process. The pharmaceutical industry has been somewhat slower to react because the palletizing of bulky packages is rare. However, the use of robots in all types of packaging has now become established and they form the basis of more than 25000 units around the world. A wide range of different robots make up this figure, as they are used in many areas of packaging; from the handling of unpackaged goods, to the secondary packaging stage, right up to palletizing and transportation. In pharmaceuticals, they are largely restricted to feed placing, secondary handling, cartoning and, occasionally, palletizing. 

Predominantly, robots are used to pack large numbers of small products into multi — or mixed — packs within a very short time, such as blister cards into cartons or onto conveyors for wrapping. Increasingly, products such as medical devices (e.g., inhalers and prefilled syringes) are packed using robots.

In the food industry, high-speed packaging lines have been developed for high volume output and many of the systems are capable of packaging several thousand products per minute. These speeds are rarely required by the pharmaceutical industry and linear high-speed systems are almost never needed at all for end-of-line packing, cartoning and palletizing. Flexibility, availability and reliable uptime efficiency are far more important. 

For end-of-line-packing, the preferred choice is to adopt robot cell arrangements. In such a configuration, multiple axis — usually six-axis — machines perform a variety of flexible functions. These can include case or carton forming, as well as picking and placement of the products into the completed cases. Ancillaries, such as check weighers and packaging printing (e.g., barcoding) can be incorporated and located within the cell to consume minimal floor space. Indeed, the cell approach consumes significantly less floor space than a comparable linear packing line. Additionally, access to the ancillaries also makes maintenance or replacement of units quick and easy — an important consideration where availability of the system is key. 

Some handling processes use SCARA or hexapod delta robots. Thanks to the compact dimensions of the delta kinematics, and the associated high speeds and acceleration properties, it is now possible to handle high numbers of products in confined spaces, in a very short time, and with relatively low energy requirements. Some of these robots have acceleration up to 10G with picking capabilities of more than 300 parts/min. 

The fast handling speeds are down to the fact that in today's generation of robots, the control concept makes use of the very latest advances in computer processing speed. PC-based solutions, with their open architecture, have really made their mark.  

Some applications use machine vision systems and image processing and, for more reliable operation, this can be directly incorporated into the motion controller of the robot. This comprehensive integration of all components into one platform facilitates efficient communication and guarantees reliable robot operation. Peripheral devices, which are used in large numbers in packaging systems, are also easily combined into a system through standard interfaces or field bus. 

Users are now able to control robots via user-friendly programming interfaces, which have been simplified so that engineers familiar with programmable logic controls (PLCs) are also able to program robots. The user interface for every robot is a screen where it is easy to 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. Smaller operators are increasingly adopting this open technology, leading to a boom in the use of robots. There are also advantages when it comes to service and maintenance.

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 stage. This is often achieved manually or by using more conventional methods such as "side loading" or "wrap around" solutions. Conventional methods offer little flexibility and take up a great deal of space, while manual workers can be expensive. As a result, for both ergonomic and economic reasons, robotic systems are very much in demand in this area. The story is similar in secondary packaging, where the trend of replacing manual work with flexible robot systems continues unabated. Again, the use of six-axis machines brings enormous benefits in terms of the flexibility and capability to handle varying products — particularly when configured in cells rather than lines. 

In both primary and secondary areas, replacing humans with robots can be a major cost consideration and robot suppliers should be conscious of supplying machines at acceptable price levels.  

In a recent study conducted at a pharmaceutical manufacturing plant in the US, ABB calculated the labour costs for running a line with purely manual operation, using a traditional, commercially available case packer and a robotic solution. Taking into consideration changeover times, adjustment, downtime, testing samples, cleaning and visual inspection, the results showed a labour cost per shift of $4500 for a purely manual line, $1000 using case packing machinery and just $500 deploying a robot cell solution. 

Handling of all sorts of products can be achieved using robots and there are many standardized solutions that can be incorporated into system concepts that extend the packaging process. Cartoning systems are predominantly offered with differing numbers of product infeeds, and the cartons can also be handled by the robots or fed in manually. With standardized carton sizes, the complexity of a system is limited and simple operation via a menu can be achieved. The flexibility of the robot is also high because it is possible to work with different gripper variants. 

Robots possess many features that render them invaluable in pharmaceutical businesses. Robots have the ability to create greater pack variety and can integrate packaging processes. For instance, the simple inclusion of patient care leaflets poses an additional packaging need — especially if the information is market dependent and has in itself a number of variants. There is also the ability to package multiple packs — such as one blister card, two or more in varying pack sizes within a single line. 

Some advanced systems enable the robots to automatically configure themselves according to preordained recipes, such as being able to change grippers as well as the motion programs, and, as the automation is secure, such arrangements simplify validation processes. 

Robots can also be ideal for automatically compiling packs such as:  

Assembled packages, such as for wrapping inhalers with associated ancillaries and leaflets.

Multipart drug treatments, for example, certain cold and flu remedies that have day and night time tablets.

Some linctus products, including measuring spoons or cups within the carton.

In a recently installed end-of-line packing system for a Japanese manufacturer of inhalers, an expensive plastic case design could be replaced by a cheaper cardboard version because vacuum dust extraction was able to be incorporated within the robot cell. The robot was also programmed to apply a clear plastic label to identify if dust or particulate contamination was evident on the outside of the inhalers. Similarly, the cell was able to apply a tamper evident seal to the carton. 

As part of an overall system, robotics technology complies with the stringent validation requirements of both GAMP and FDA 21 CFR Part 11. As robots, once programmed, are infallible, all that needs to be done to ensure compliance with validation is to have the customary software locks and electronic signatures, which are becoming commonplace with pharma process software. 

Also, with flexible systems where perhaps several pack styles are produced on a single line, the individual programs can be similarly secured. All that then needs to be done is to ensure the correct grippers are fitted — a function that may easily fall outside validation requirements as it is unlikely to affect the process itself if an error were to be made. 

In the most futuristic setting, cartons will be transported automatically by wire or laser guided vehicles that are fitted with sensors that enable them to find their own way to the storage areas. 

Robot technology means that it is now possible for a fully automated system to take a pharmaceutical product from the manufacturing process right through to the delivery point. Further development of the open control technology and existing robot mechanisms will lead to robots taking on ever more critical roles in systems of the future. Inflexible proprietary automation counterparts will be pushed further into the background and may possibly disappear completely from potential pharmaceutical applications. 

is the global segment manager pharmaceuticals for consumer industries at ABB's Robotics Division. His experience extends to working with global pharmaceutical giants through to small contract manufacturers and co-packers. 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. 

Never has greater pressure been applied to pharmaceutical manufacturers. Shelf space competition for branded drugs has reached aggressive proportions and now even prescription drugs vie for pricing and delivery. Against this is a backdrop of ever-increasing downward price pressures, and a spectrum of progressively more stringent legislative and quality requirements. Finally, regional markets now demand different tamper evidence technology, anticounterfeiting measures and safeguards against interference by biological terrorists. Much of which points to the need for innovation in packaging - not just in terms of pack styles and sizes, but also cost.