Optimizing Integration of End-of-Line Packaging Systems for Medical Devices
Integrated systems enhance product integrity and improve product safety and regulatory compliance
By Jason Enninga, Vice President for the Robotics and End-of-Line group at Brenton
The primary purpose of secondary packaging is to ensure the safety of a product during storage and transportation. The integrity of secondary packaging is particularly important with medical devices, such as tongue depressors, syringes, blood glucose meters, programmable pacemakers and others, where product safety is by far the most prevalent consideration for these mission-critical items.
The FDA does not just monitor and control the manufacture of medical devices, it also ensures the packaging used is safe and effective at keeping the contents clean and germ-free. The FDA expects manufacturers to provide packaging that protects against environmental conditions, such as the transport and aging of the packaging material itself, which could weaken over time and expose the contents to pathogens.
Because of the critical nature of medical devices, these requirements demand a higher expectation of performance from end-of-line secondary packaging systems like case erectors, case packers, case sealers, labelers, palletizers and stretch wrappers, as well as the material handling systems that connect them.
For medical device manufacturing, end-of-line secondary-packaging systems must produce reliable and cost-effective results, while complying with FDA guidelines. This includes high-volume throughput, packaging flexibility, handling of delicate medical devices without damage, and maintaining industry standards for cleanliness and sterility.
Turnkey integration of end-of-line packaging systems
Maximizing the capabilities of these individual packaging systems depends upon how smoothly they are integrated into a singular, optimized packaging line.
End-of-line solutions for medical device manufacturing – particularly when robotics is employed for pick-and-place case packing or palletizing – may appear as straightforward as acquiring and programming the machinery and robots. But in reality, this is just the beginning. Programming is the easy part. Making the ancillary systems work together, and presenting the products to the individual systems and robots so they are not doing more work than is necessary can be challenging, requiring considerable expertise.
This expertise can be found exclusively with the end-of-line original equipment manufacturers (OEMs), in terms of understanding the upstream and downstream inputs and outputs to the machines that will serve to optimize the entire system. End-of-line machinery today has the latest in servo-motion control technology for fast and reliable changeovers, superior diagnostics for quick identification of root-cause issues, and first-rate technical support, all of which contribute to high-end overall equipment effectiveness (OEE) metrics.
An OEM’s turnkey integration typically includes evaluation of all the machines on the line for safe operation as defined by current industry standards, and taking steps to bring these systems up to those standards by adding guards, emergency shut offs, hold-in-place actuators, etc. Simply bolting on conveyors between machines and writing control code to ensure proper handshakes between programmable logic controllers (PLCs) is not enough.
Some packaging machinery OEM’s are uniquely positioned to deliver a pre-tested, fully-functioning end-of-line system assembled in one location at the OEM’s plant, rather than assembling the line and testing it at the medical device manufacturer’s facility. This gives medical device manufacturers the opportunity to evaluate the performance of the entire line before installation, which is considerably more time-efficient and less costly than machine-by-machine demonstrations in isolation.
Hard automation versus robotic end-of-line systems
Installing either hard automation or robotic systems into an end-of-line packaging operation for medical devices are an application-by-application decision based on the items to be packed, the pack configuration, desired speeds, the space available at the facility, and a company’s general equipment philosophy. Finding the best solution requires an analysis of the product, the package, a company’s current needs and its potential plan for future growth.
Typically, if robotics is incorporated into an end-of line solution, the ability to more efficiently process multiple SKUs, manage varying product sizes and create many pack configurations results in more streamlined throughput with reduced labor costs. Whether robotic or hard automation, these systems can be seamlessly integrated with preferred or existing equipment, case erectors, case sealers, palletizers, stretch wrappers and labelers to provide a turnkey integration.
Material handling with pick and place robotic systems
Utilizing 5- and 6–axis articulating-arm robots, delta-style high-speed robots, and 4-axis SCARA (Selective Compliance Articulated Robot Arm) robots, a wide range of applications are possible for pick-and-place, sorting and inter-plant routing for end-of-line material handling. These robots are well suited for picking products and placing them into secondary packaging with excellent repeatability performance and high-level accuracy which supports handling sensitive and fragile medical devices.
Robotic material handling systems are low maintenance, flexible and reconfigurable, and especially beneficial in end-of-line packaging when dealing with hazardous and potentially injury-causing materials.
Much of the technology of pick-and-place with robots is involved in engineering end of arm tooling (EOAT), used to pick up the items. The design of clamping and vacuum-based arm tool picking solutions contributes to establishing precision product placement and handling, and successful pick rates without product damage.
For example, with flow-wrapped products, too much vacuum on the EOAT will pull air through the plastic or cause the plastic to get puckered or deformed, but the vacuum has to be adequate to move the product successfully. Clamp-style tools need to be robust enough to survive a crash, but not too heavy that they require a larger robot to handle payloads and the inertia at play.
There is also the metering and presentation of the products into queue to be picked by the robot. Aside from PLC functionality, also at play is a system of sensors and signals that tell the robot when and where a product is in position to be picked, and if a product has been missed and left behind. Vision systems permit random picking and arrangement of products as desired. Factually, this is where the real skill in robotics pick-and-place automation comes into play to effectively manipulate on small scales, with odd product sizes, and randomly oriented pieces.
Palletizing reduces product damage and shipping costs
Robotic palletizers provide considerable improvements, including more options for customized pallet configurations, faster changeovers for different packaging runs, tighter and more cubically-optimized pallet loads for reduced shipping costs and less possibility for product damage.
Automated infeed palletizers are ideal for packaging operations ranging from 30 to over 100 cases per minute, and can serve single- or multiple-packaging lines. Robotic palletization, however, provides significant advantages. Today’s robotic palletizers are capable of building a higher, more dense and more stable pallet than prior systems, with improvements in speed, order accuracy and flexibility.
The execution of pallet-building functions calculates the case and packaging contact surfaces, and determines the layering of the individual packages, which is critical to producing a stable palletizing pattern. Stacking criteria is modified by a number of factors including size and shape of the case or package, crushability, stability factors, volume of cases per layer, number of layers and the layer patterns.
The latest robotic palletizers can handle speeds of 20 cycles per minute, while handling cases, bundles, bags or large objects with complex pack patterns. The entire cycle from in-routing of cases into the palletizing station, case identification and labeling, palletizing, stretch wrapping and pallet license plating is accomplished within the palletizing station.
Robotic palletizers, as well as conventional automated infeed palletizers, when smoothly integrated with upstream end-of-line systems, deliver reduced labor hours and reduced downtime, with more consistent end-of-line throughput.
Enhanced product integrity improves patient safety
Medical device manufacturers are continually focused on enhancing product integrity to improve patient safety. Optimizing the integration of end-of-line packaging systems facilitates streamlined throughput for the handling of these life-critical medical device products.
Those healthcare industry manufacturers that endeavor to make the upgrade to these systems will not only experience reduced product defects and a higher level of product quality, but also a more efficiently run and profitable plant.
About the Author
Jason Enninga is the Vice President for the Robotics and End-of-Line group at Brenton. He can be reached at Jason.Enninga@promachbuilt.com.