Figure 3: A robotic autosampler loads test tubes into an analytical instrument.(

Various primary packaging configurations can also be handled. "If you're packaging in a blister pack from a small dosage all the way to a large capsule, robots allow you to have a quick switchover and do high-speed repetitive moves or motions that, in many cases, an operator cannot handle," says Doug Burns, head of the sustainability group at Rockwell.

Tallian identifies at least two major factors for the increased demand for robotics in packaging. First, some large retail outlets are now demanding different packaging configurations. Instead of, or in addition to, the large-count pill bottles (e.g., 250–300 count bottles) that traditionally have been shipped to a retailer's pharmacy, retailers want smaller-count, easy-to-use configurations so that their pharmacists do not need to handle the product on site.

Potential applications

Although many companies have successfully incorporated robots into pharmaceutical laboratories and packaging, they have been slow to use them for manufacturing applications, says Martin Van Trieste, vice-president of quality at Amgen (Thousand Oaks, CA).

Because it is a repetitive activity that requires great reproducibility to produce a high-quality product, aseptic filling would particularly benefit from robotic automation. "Successful aseptic filling requires impeccable operational discipline to consistently produce sterile products. We also know that the human body is the greatest source of contamination in a pharmaceutical cleanroom. Any technology that can remove the operator from the cleanroom logically will provide for a higher probability of producing a sterile product," says Van Trieste.

In addition, robots could enhance quality assurance and quality control by enabling 100% inspection, which is difficult for humans to achieve. A robotic system consisting of several cameras and a conveyor belt "could actually take a picture of each pill as it goes down the line and kick off any minor, imperceptible flaw, so that only perfect product gets through," says Barrett. Robots can check products for weight, color, or barcodes, he adds.

Criteria for using robots

Robots are not appropriate for every pharmaceutical process, and manufacturers should consider certain criteria to determine where to apply this form of automation. In general, a highly repetitive and highly precise process is a good candidate for roboticization. Many robots perform at high speed and are adapted to high-volume processes. And robots could also perform low-volume operations that completely consume an employee's time.

Quality control is another criterion to consider. "If you want to have a highly repeatable process, particularly if it's a fairly delicate process, robots are extremely repeatable," says Carlisle. Robots also are a good choice in cleanrooms and other operations where contamination must be controlled, he adds. The machines can protect drugs from contamination and shield humans from potentially harmful products or processes.

Drugmakers can seek outside advice when determining when to incorporate robots into their operations. A robotics integrator can perform a line audit and evaluate a company's manufacturing and packaging processes to identify opportunities for robots to improve processes (e.g., by increasing speed, increasing efficiency, reducing rework, and reducing scrap). A robotics integrator can also assess the sophistication and training of operators and maintenance personnel and propose the correct training for the application and the support structure, says Langosch.

The economic case

Before implementing robotic systems, a company must consider their economic implications. The cost of robots, like that of other established technology, has been steadily decreasing. "Replacing a piece of outdated or slower equipment with the flexibility and sustainability of robotic automation makes good fiscal sense," says Langosch.

The cost of implementing robots in pilot production "amortizes itself in a reasonable return-on-investment time," says Barrett. Robots' flexibility allows companies to produce small lots of a drug and to change to a different product quickly without incurring the capital cost of fixed-price automation. "That makes it very viable, especially for vendors that are working on genomically targeted drugs and niche markets," says Barrett.

On the other hand, robotics would probably be far more expensive at the consumer-product scale than setting up the process line would be. "If it's going to cost you $2 billion to build your factory and produce aspirin, then the cost per aspirin is very low. If you can't guarantee you have that quantity per year, then it's economically more viable to do it with robotic automation," says Barrett.

Sometimes robots can be deployed strictly to reduce costs. But pharmaceutical companies can find more opportunities for robots to improve product quality and employee safety, adds Van Trieste.

Others argue that adding robots to pharmaceutical processes usually makes good economic sense. "By taking into account increases in productivity and efficiency and reduction in scrap, garments, rework, and manpower cost, the cost of robotic automation is often justified," says Langosch.

Installing and controlling robots

The easiest way to install a robot is to buy a process that already includes one. When this is not possible, a drugmaker must buy a robot or design one that is appropriate for its process. In either case, the company will likely need the help of a mechanical engineer and a software engineer. Manufacturers of robotic systems "have made great strides with their software and tools, making implementation easier," says Van Trieste.

Usually, a robot is installed into a work cell. "Robots are completely compatible with other unit operations and packaging equipment," says Langosch. A mechanical engineer can help the company adapt the workcell to accommodate the robot. A software engineer can write a program that controls the robot and allows it to communicate with the other instruments in the cell. During installation, manufacturers should follow guidelines for guarding and safety such as the American National Standards Institute's RIA R15.06-1999 Robot Safety Standard, says Langosch.

After a robotic system has been installed, a robotics engineer must test each part of it to ensure that it performs correctly and is programmed appropriately. All human–machine interfaces must also be checked. In general, companies only make minor modifications to the system after it has been installed. Manufacturers should periodically check the performance of their robotic systems after installation Figure 2: A high-speed robot (ABB IRB 360 FlexPicker) picks and places vaccine droppers.to verify that they're performing properly.

Constant and consistent preventive maintenance is critical to ensure that robots perform well. Companies should establish a preventive-maintenance schedule and look for problems such as leaks and wear on pulleys, gears, or moving parts.

Installing a robot is usually no more complicated than installing most packaging machines, and a robotic integrator can address problems that arise during the process, says Langosch.

Many of the major robotics manufacturers have their own application software package, which makes control easier than writing lines of program. For example, ABB's Pickmaster ease-of-use programming package is presented in a drag-and-drop Windows environment that develops about 95% of the robot software without having to write the software.

Traditional robotics use a dedicated robot controller, but there are options where one can integrate control of the robot directly into the main line controller. "That is what we have been promoting," says Bob Hirschinger, product marketing manager at Rockwell. "Often we have primary line control with our control products and we've added capability to those controls that allow us to directly control robotics without the need for the dedicated robotics controller. A broad range of transforms and high level robotic functions facilitate fast and easy integration of robots."

"In pharma applications, it also makes validation easier on the machine because you can integrate control of the robot into the machine controller so you can have integrated recipe management and integrated calibration. It is much easier to collect track-and-trace data," says Burns.