Improvements in Form-Fill-Seal Technology
Advances in sealing and electronics are making form-fill-seal packaging a viable option for a variety of devices.
Erik Swain, Senior Editor
More medical device firms are using form-fill-seal technologies for their packaging operations. And it's not just because they allow for automation. They also make for greater productivity in the packaging process. Advancements in the technology are enabling a wider variety of products to be packaged and providing a more consistent seal than might be achieved by other means.
Form-fill-seal used to be pegged as a process that only made sense for smaller, higher-volume products. Larger or oddly shaped devices weren't easy to form around, and lower-volume de-vices didn't always justify the expense of the equipment. But these concerns aren't as great as they once were. Newer form-fill-seal technologies adapt to more sizes and shapes and can provide added value with features such as data collection.
SEALING AND CONTAINMENT
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Device firms have always been attracted to form-fill-seal by its ability to package higher volumes at higher speeds. And the desire to save packaging costs by moving out of rigid trays has boosted the technology's popularity as well. (See "Sticking to Speed and Safety" sidebar)
"Horizontal form-fill-seal packaging equipment offers the opportunity for producers to increase throughput because of the wide variety of formats that can be used with the equipment and due to the high cycle speeds that can be achieved," says Russ Garofalo, vice president of sales and marketing for Mahaffy & Harder Engineering Co. (Fairfield, NJ). "In many cases, it has been changes in the technology that has positively affected these increases in throughput. Changes such as the use of servomotors is allowing for the faster cycle speeds."
But other factors are now coming to the fore, such as the quality of sealing. "Suppliers have been developing materials and processes that allow for better and faster sealing, for a seal that has full integrity and is easier for the user to open," says Daniel Alcombright, PE, manager of project engineering at Remmele Engineering (St. Paul, MN).
Jon Ford, president of Hooper Engineering, a division of Harpak Inc. (Easton, MA), agrees, noting that "seal integrity, especially on a peel seal, is consistent on form-fill-seal, ensuring sterility."
This comes in contrast to manually sealed premade pouches where "the consistency of the seal just isn't there," says Mark Steinbrecher, sales manager for Optima Machinery Corp. (Green Bay, WI). "Another disadvantage to manual sealing is the labor intensiveness, and at higher volumes it can become an ergonomics issue with concerns about carpal tunnel syndrome."
Also important, says Ford, is the form-fill-seal format's ability to contain the product tightly. "A lot of products put in premade pouches are loosely held," he says. "Form-fill-seal gives you the opportunity to shape a cavity to fit around a product, so it will be held more tightly, and there could be less damage to it. In fact, we have developed a heating technology that allows us to do a package with undercuts, where a product actually locks to the package and enables it to form around very difficult shapes. It also gives a definite improvement in wall thickness and flatter seals."
Roger Stanton, president of Bossar USA Inc. (Sarasota, FL), agrees that the technology can accommodate less conventional shapes these days. "We have handled a variety of strange-shaped medical devices, including dental adhesive tips, rectal probes, pregnancy test kits, vaginal rings, EKG pads, suture needles with catgut, and medical lollies for kids, to name but a few."
Another contributor to the increased use of form-fill-seal is that the size of the device is not the factor that it once was, especially if the system has a large loading area.
"We've packaged devices as long as one meter," says Wilmer Caraballo, technical manager for the medical, consumer, and industrial division of Multivac Inc. (Kansas City, MO). "In fact, long catheters lend themselves well to this equipment because of the ease of loading. It can do large or small devices just as effectively." In fact, he notes, one of the hallmarks of the new form-fill-seal technologies is their ability to change from one device to another without manually replacing a tool or die, because the dies can be adjusted automatically, cutting down the time between runs.
Electronic features are a major selling point of the latest models, as they enable better control of the process and more-thorough documentation.
"We have been able to implement a more modern and state-of-the-art control system, which maintains closer parameters and allows us to use less-expensive materials," says Caraballo. "A lot of our customers are requiring features that help them in validation and with QSR and ISO compliance. There is a large amount of requests for data-acquisition features, because regulatory bodies are requiring more process validation and documentation. Electronic features make it easier to download parameters and maintain records in an easy manner. You can choose to download the information onto a network, or a separate PC, or a printer. If there are any errors, your production data tells you where they are occurring."
Of great help is that many newer models are easier to validate than their predecessors. "Our newer machines have a data-acquisition system that maintains records of the temperature, pressure, and speed of the entire process," says Steve Joosten, product manager for Circle Packaging Machinery Inc. (Green Bay, WI). "Each seal location is monitored, and the data-acquisition portion of the software takes care of reading and graphing the parameters."
John Merritt, managing director of Tiromat Medical Packaging (Frisco, TX), agrees and says there is room for further advances. "We are still exploiting the potential for data collection, massaging, and archiving, and we believe there is still significant untapped potential relative to production and control as well as quality assurance. Not everyone has taken advantage of the power of the machines in terms of the information they can produce, store, and report."
In fact, some vendors have taken the extra step of doing some of the validation themselves. "We have taken a very serious role in prevalidating the equipment before delivery," Ford says. "Historically, the machines have taken longer to validate than to build. We've built in controls that make it easier to validate pneumatic gauges and seal temperatures, and we can provide this information to the customer before the equipment is shipped. We can even do a design of experiment on the package. In one application, this reduced validation time by seven months."
Printing adaptability has been another factor behind form-fill-seal acceptance. "Advances in printing technology have allowed us to maintain high speeds while printing date codes and bar codes on-line," Caraballo says.
Given how well form-fill-seal technology has been embraced for medical packaging, it will not be surprising to see it make its way into even more applications.
"We're now seeing form-fill-seal being done in aseptic formats," Alcombright says. "It requires special engineering for that environment, but it is being done."