Customizing Form-Fill-Seal Lines
To support today’s medical device packaging requirements, equipment manufacturers are working diligently to customize packaging lines, especially those including form-fill-seal machinery. “Most device manufacturers have their own requirements, which we must blend into the design of any line,” says Bob Koch, director of sales for Multivac Inc. “This is the norm, not the exception.” Multivac provides thermoform-fill-seal and vacuum-sealing machinery as well as ancillary equipment for feeding, printing, and inspection.
Kevin Ryan, pharmaceutical/medical technical sales at Formost Fuji, also sees demand for some customization. “All packaging solutions start with the product requirements and tend to be unique solutions for the application. However, by providing the flexibility and intelligence capability on the standard machine, the unique requirements of the application can be achieved with machine settings.” Formost Fuji provides flow wrapping machines that can be used for pharmaceuticals and medical devices.
Vin Faherty, product manager for Harpak, reports that “customers are requesting very specific requirements as to controls, software, and customization of operator interface. Requests are centering around FDA concerns, such as the ability to track the process. Software validation is another area of concern.”
In addition to “state-of-the-art control systems,” Mike Summersett, director of operations, horizontal product line, for Ossid LLC, is seeing growing demand for reliability metrics tracking (RMT) for equipment. “RMT in its essence is the measurement of equipment efficiency,” he says. “For each customer, this is a unique set of parameters that they want the ability to track. It can range from downtime monitoring to temperature or pressure trending. The final outcome of it all is more up time, predictive maintenance, and most of all, product quality. We will be working to expand the role of RMT in our control architecture for our customers’ success and our process knowledge.”
In addition, medical device manufacturers are asking how Harpak “can help to shorten the validation process once equipment arrives in their facility,” Faherty adds. “We continue to offer pre-validation runs where we develop a process running at a set cycle time.”
Faherty explains that one of Harpak’s latest applications has been the integration of a complete system. The project encompassed functions “from loading of primary package to the discharge of products,” he explains. “This represents a turnkey integration of an entire packaging line.”
Summersett of Ossid sees increased requests for turnkey projects. “In this trend we are seeing more and more requests not only for our horizontal form-fill-seal machinery, but also for product-handling equipment both upstream and downstream from our machines.”
One such project entailed a medical device packaging line that had a requirement for a unique discharge from the machine to accommodate downstream activities, explains Summersett. “This was a long device that was being packaged, so the means became more complicated than usual,” he says.
At Pack Expo International in Chicago, Multivac will showcase an automated packaging line featuring its R535 horizontal form-fill-seal packaging machine. Able to handle a range of flexible or rigid multiple-layer materials, the R535 employs a die changeover system designed to minimize downtime during format changes and a new waste disposal system for efficient trim removal at the end of the machine.
According to Multivac, the company can customize the R535 from end to end for a complete automated packaging line. “You’ll have a single point of responsibility and accountability for your packaging installation—even when we incorporate systems from third-party suppliers,” says Koch.
Multivac’s demonstration will show the R535 featuring a Multivac H240 robotics portal equipped with twin Delta robot pickers guided by an integrated vision system. Koch explains that the robotic arms can pick randomly fed items from a supply
conveyor at a rate up to 95 items per minute and orient them correctly into the thermoformed cavities. A feeding unit can add inserts, and a Multivac labeling system can produce customized labels for each package in the array featuring serialization and then label each insert. The labeler can be fully integrated into the overall control platform of the line. The array indexes into the sealing head, where a top film seals the contents inside the packages.
After exiting the sealing head on the Multivac R535, all packages are subjected to a contact-less 100% seal inspection with a dynamic scanning system seamlessly integrated into the machine. Koch reports that the vision-based system can reliably detect incomplete sealing seams, imperfections in the seal area such as bubbles or wrinkles, and contaminants as small as 0.5 sq mm. Individual non-conforming packs are documented in the line’s motion control system and can be marked and ejected specifically at the exit of the line by a discharge handling robot or other end-of-line solution.
Once inspected, the packages are cut free of the web in a sequential process with energy efficient electric cutting units, explains Koch. Packages then exit the machine into Multivac’s H050 robotic handling system, where the five tracks of products are placed into a stacked single track configuration for pack-off.
Summersett reports Ossid is getting more requests for package printing and vision inspection for print confirmation. “We continue to partner with good printer companies and vision systems that integrate well into our machines.”
Medical device manufacturers are also interested in controlling costs where they can. “Primary concern has been and will continue to be product protection inside the package. This is always challenging when combined with the need to reduce packaging costs as much as possible,” says Summersett.
Harpak’s Faherty sees such trends in several industries. “In all market segments, higher production rates, lower operation costs, and greater efficiencies are of utmost concern,” he concludes.
Multivac is getting requests for energy-savings solutions. “We are continually searching for energy-saving components and include them as possible,” reports Koch. The R535 features energy-savings processes such as cooling water that automatically throttles back during production breaks and electrically driven lifting units eliminating the need for expensive compressed air, adds Koch.