Evaluating robotics for pharmaceutical packaging
06/01/2005
To determine if your cleanroom or contamination-controlled packaging line is ready for robotics, the overall benefits of automating must be understood
Ignacio Mu??oz-Guerra, General Director, AutoPak Engineering Corporation
Today’s pharmaceutical manufacturers are challenged by strict contamination-control requirements, increased brand turnover and broader product lines in a range of formats and sizes. To speed time to market and accommodate an assortment of packaging styles, pharmaceutical manufacturers need to increase flexibility on production lines and streamline the changeover process to maximize return on capital expenditure, all while staying within the boundaries of sterilization regulatory standards.
Incorporating robotics has proven to be a cost-effective and efficient solution. Offering speed, flexibility and ease of use, robots reduce contamination risk while providing greater flexibility and accommodating more products per manufacturing line than ever before. In 2004 alone, the North American industrial robotics market for medical and pharmaceutical applications generated revenues of $394 million, and it is estimated that this figure will reach $668.4 million by 2011.1
While it is clear that robots are carving a niche in sanitary packaging operations, it is important to note that not all pharmaceutical production lines are created equal. While sterile environments are faced with many of the same stringent production regulations, what works for one pharmaceutical manufacturer does not always work for another. The decision to integrate robotics into a pharmaceutical packaging line warrants careful evaluation and expert guidance.
Overall advantages of robotic automation
To determine if your cleanroom or contamination-controlled packaging line is ready for robotics, the overall benefits of automating must be understood. One of the most obvious advantages is increased line speed. Robots can perform uniform functions quickly with fewer errors and little downtime. This is highly relevant in pharmaceutical manufacturing, which requires high-speed, repetitive motions and accuracy. Moreover, using robots to perform routine, labor-intensive tasks frees personnel to focus their knowledge and skills on other aspects of production.
Robots also add flexibility to manufacturing lines. Because early robot models were difficult to reprogram, many packaging processes were manually operated to accommodate short product runs and changing specifications. But with today’s advancing technology, robots are easily retooled with user-friendly software.
In addition, installation and operation of robots are much less complex than in the past. Robots can now be integrated into existing systems in a matter of hours. Interfaces are more intuitive and user-friendly, simplifying operation.
As robotic automation grows in popularity, the cost to implement the technology is decreasing. In 2004, international robot prices were an average of 46 percent lower than in 1990. Moreover, as prices drop, quality and performance are improving. For example, robots in 2004 have 70 percent greater accuracy and 200 percent longer meantime-between-failure than in 1990, but still cost less. The price of a robot purchased in 2004 is less than one-fourth that of a robot in 1990 with the same performance ability.2 In short, robotic technology is more cost-effective than ever.
Clean packaging options
Despite the clear benefits of robotic automation and decreasing implementation costs, cleanroom manufacturers often find it difficult to justify the up-front investment. However, integrating robotics in a cleanroom line affords special advantages, including:
• Enhanced contamination control: Reducing manual labor lowers the risks of human error and contamination, important concerns of pharmaceutical and cleanroom manufacturers. For example, automated systems in pharmaceutical laboratories regularly achieve a contamination frequency level of 1 in 50 million as compared to just 1 in 20 in manual handling.3
• Improved lot consistency: Products processed in cleanroom environments must meet rigorous quality standards. The high degree of robotic operating accuracy results in less product damage, fewer defects and reduced waste. This lowers product liability costs and increases customer satisfaction.
• Reduced operating costs: Because one robot can typically perform the same manual work as three to five humans, employees can be diverted to more strategic functions outside the cleanroom. This will drastically reduce operating expenses, as human participation in cleanrooms is quite costly. Humans need to be outfitted in gowns, costing approximately $150 for a Class 1000 (ISO Class 6) environment, as well as gloves and hoods. Garments must be changed twice daily, a time-consuming and expensive process. Removing humans from labor-intensive positions also reduces workers’ compensation costs. In addition, plant costs decrease because product previously requiring three to five manual workstations can now be outputted with just one robotic cell.
• Increased production flexibility: Reprogramming a robot to accommodate new products is less time-consuming and costly than retraining humans. Because robots do not face the challenges of a lengthy learning curve, changeover is smooth and the probability of error lessened. This is highly relevant in cleanroom manufacturing, where there is no room for error.
• Space maximization: Cleanrooms are typically confined environments because the larger they are in area, the harder it is to control particle emission. By employing robots, manufacturers can reduce the area required to run a production line. Emergency exits, for example, can be eliminated. Additionally, robots can be placed in harsh and restricted spaces.
• Increased line safety: Companies must provide a safe work environment for their employees. This is difficult in cleanroom settings, which are typically not people-friendly environments due to factors such as dangerous chemicals, strong cleaning solutions and severe temperatures. Moreover, the packaging of pharmaceuticals often requires lifting and repetitive motions, major causes of back and neck injuries. With robots performing the more hazardous functions, workers can move into other positions. An overall improvement in line safety will lead to less downtime and greater efficiency.
The abovementioned factors can positively affect the overall profitability of the manufacturing process. But the exact amount of savings in each area must be determined in order to justify the expense of employing a robotic system. An experienced automation solutions provider can objectively evaluate your manufacturing line and assist in the decision-making process.
Choosing a robot that meets cleanroom regulations
Once it is clear that robotics can benefit your cleanroom packaging line, the next step is to select the robot best suited for your requirements (see Fig. 1). Due to the strict laws governing the use of robotics in sterile applications and the huge selection of robot models on the market, the guidance of a third-party robotics expert is helpful.
Selecting the right robotics integration partner is extremely important. A third-party firm with industry expertise can determine if and when the expense of robotics will be beneficial. The consultant can also pinpoint which areas of the manufacturing process are best suited for robotics, if any, since a robotic-free line may be ideal in some cases.
For example, irregularly shaped products that differ considerably can only be handled by highly advanced and customized robots. If these products are estimated to have a short lifespan, the expense of the robot will not be justifiable.
However, if robotics are determined feasible, several factors must be considered before selecting the specific equipment to be used:
• Particle emission: The American Federal Standard 209E mandates that cleanroom processors employ robots with controlled particle emission. Air in Class 100 (equivalent to ISO Class 5) cleanrooms, for example, can have a per-cubic-foot particle count of no more than 100 in a size range of 0.5 micron and larger within one foot of the work space.4 Traditional robots generate particles that are not acceptable in sanitary environments. On the other hand, cleanroom-friendly robots reduce particle generation by exhausting particles through their bases into air chases, for instance.
• Ease of cleaning: The FDA mandates that cleanroom lines be frequently cleansed. Therefore, easily sterilized robotic models are a must. Pharmaceutical line robots must be able to handle end-of-shift spray wash-downs.
• Surface specifications: The surface of the robot must conform to cleanroom guidelines. Painted steel and anodized aluminum are authorized, with polyurethane as the recommended coating. However, decorative and galvanized finishes are not permitted. Nonpainted parts must be protected from corrosion.
• Seals: Robot joints and caps must be welded and tightly secured to prevent leakage and dirt build-up, and facilitate cleaning. The seal and gasket materials must be FDA-approved.
Other factors to consider include product characteristics, such as size, shape and weight, plant layout and existing ancillary packaging equipment.
Robots in cleanroom packaging
There is a vital role for robotics to play in cleanroom pharmaceutical packaging, including palletizing, material handling, case packing, and pick and place functions.
 Figure 2. This robotic palletizer loads boxes onto pallets, eliminating manual heavy lifting. |
Pick and place robots move products from one area to another. In the pharmaceutical industry, these robots are typically used to pack goods into trays or secondary packages (see Fig. 2). Because the motion is repetitive and straining, robots perform better than humans. Robots will also lower the contamination risk.
Applying robotics to both palletizing (loading and unloading packages on pallet bases) and case packing has great advantages as well. From an ergonomic standpoint, robots alleviate the need to repeatedly lift heavy items manually. Robots also impact productivity by increasing palletizing/packing speeds and throughput. Security is also enhanced through automatic bar code reading, which verifies which boxes to palletize/pack. The initial expense of palletizing and case packing robots can typically be justified within one year.
Successful integration
By implementing robotic solutions, cleanroom manufacturers stand to reap significant benefits including enhanced contamination control, improved lot consistency and quality, greater throughput, increased production flexibility, better safety in manufacturing and increased profits. Even so, the decision to add robotics is not one to be taken lightly, especially for cleanroom manufacturers.
To determine if your cleanroom packaging line is ready for robotics, thoroughly evaluate the technology’s benefits and accordance with regulatory stipulations. Apply these advantages to your line to establish whether the savings will surpass the initial expense. An experienced robotics integration firm can facilitate this process, allowing you to leverage robotic technology to develop an efficient cleanroom solution. III
Ignacio Muñoz-Guerra, founder and general director of AutoPak Engineering Corporation, has over twenty-five years of experience in developing innovative solutions for pharmaceutical and consumer good packaging lines. Muñoz-Guerra received a B.S. in Mechanical Engineering from Princeton University. He can be reached at [email protected] or (787) 723-8036.
References
1. “Industrial Robots Poised for Strong Growth in Medical and Pharmaceutical Applications.” Frost & Sullivan. March 30, 2005.
2. “Robot Investments Surge to Record Levels.” United Nations Economic Commission for Europe. February 4, 2005.
3. Whitton, Simon. “Life Science Laboratory Automation.” Advances in Life Sciences. February 2, 2002.
4. Food and Drug Administration (FDA). “Sterile Drug Products Produced by Aseptic Processing Draft.” http://www.fda.gov. May 2005.