Trends in Form-Fill-Seal Packaging
The needs of medical device companies are driving advances in form-fill-seal technology.
Lori Bryan, Contributing Editor
Medical device firms are continuing to rely on form-fill-seal (FFS) technology for their pack-aging needs, largely because of the benefits it affords them. Among these pluses are automation; higher speeds; tighter, more-consistent seals; and the accommodation of variously sized and shaped devices.
But device packagers are also de-manding more of the tried-and-true technology than ever before, to help them stay competitive in the medical marketplace.
Increasingly, device packagers are looking to FFS machines that are integrated with other packaging equipment to improve process efficiency.
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"We're asked to integrate coders, labelers, fillers, seal inspection systems, and checkweighers within our machines," says Roger Stainton, president of Bossar USA Inc. (Sarasota, FL). "The benefit is reduced usage of floor space and maximized single-operator overhead." Merging coding and filling operations with FFS equipment is most common, he says. "But as technologies progress and can be manufactured to be able to physically integrate to our machines, [integrating other equipment will be] a growing trend."
Roy Wren agrees. The technical sales advisor, medical packaging, for Multivac (Kansas City, MO) says, "The trend will continue to expand as technologies for tracing devices and components advance. Printing is the main means of tracing devices; however, electronic coding is an up-and-coming technology that will certainly be explored and utilized in the future." The formation of company alliances, he says, makes in-line operations be-come almost seamless.
According to Patrick Ditchfield, Mutivac's market development manager, medical packaging, his company is meeting a growing demand to supply complete manufacturing and packaging lines. He calls them integrated pods, describing a syringe manufacturing system that assembles the product and packages it before discharging the finished item as one example of a pod.
"The demand from our customers," Ditchfield says, "is to make these pods more and more complete. The final goal for medical device manufacturing is to go from raw components to complete ready-to-ship packages in one manufacturing pod, without loss of control, and with complete information about each product and package that can be traced to each [unit] and subsequent operations, if required."
With forthcoming advances in these areas, there is room for improvement, says John P. Merritt, president of consulting firm Merritt, Myers Inc. (Dallas). For instance, Merritt says, "In-line printers and labelers are often mounted with their own separate control panels. In most cases, the controls on the HFFS have more than enough capacity to handle the peripherals. So, with some interface and programming, there is no reason why the labeler or printer cannot be run off the main machine control panel. More focus needs to be given to integrating the control of these peripherals into the main control system of the horizontal FFS machine."
What do validation and regulatory compliance have to do with advances in FFS control systems? Quite a lot, according to Multivac's Ditchfield. "Developments in control systems are driven primarily by the demands of validation as medical packagers wrestle with the regulatory demands placed on them and coordinating these demands with GMPs and cost-effective manufacturing practices."
These demands, as Ray Johnson of Doyen Medipharm points out, are far greater than they used to be. "In the past, people were working on just meeting FDA or their regulatory department's requirements for validation. The work put into validation was never applied to help create value--that is, to increase efficiency or reduce costs." What is different now, he says, is that "the ISO 9000 requirements include suggestions for creating and evaluating a company's process improvement systems. Now the ISO process forces a real cost payback through continual process improvement systems. The same [is true] of our current efforts on validation."
As such, sophisticated electronics that can help streamline validation are playing a vital role in FFS technology. Data acquisition, storage, and reporting are important features to process reliability, validation, and compliance, Merritt says. "Today's machinery is capable of monitoring actual conditions and storing this information. This ability is key to an effective validation, and after validation it is equally important in ensuring the operation of a reliable system."
CHANGEOVERS AND ADAPTABILITY
Device firms are expecting refinements to FFS equipment that ensure quick changeovers in the face of ever- smaller, more-intricate devices.
"The complexity of the changeover in horizontal FFS machinery is proportional to the complexity of the package itself," Merritt says. While changeover for flexible packages with shallow draw and simple tools can be quite quick, he says, changeover for rigid packages with complex cutting systems can be not only laborious but sometimes impractical as well. "In this case, smaller dedicated lines avoiding changeover may be more effective. An alternative approach is to pursue much larger machinery with two or more forming and cutting stations. In this case, the tools are positioned but are only activated as needed through the control panel. Sealing tools are changed as needed, but this tool change has minimal impact on changeover time."
Multivac's customers are increasingly making requests for such systems, according to Ditchfield. They're asking us "to premount on one machine multiple tooling sets and cutting devices that are capable of producing a number of different packages without any physical changes being made by the operator." Using this technology, Ditchfield says, the packaging system is made more foolproof. An operator selects a "package recipe" on the control system for a given product SKU, and the machine's control system does the rest, choosing the tooling and cutting sets and the printing, and making changes electronically so that the right forming die is activated and used.
In addition, device packagers are de-manding adaptable FFS technologies that will meet their needs today--and tomorrow. "The medical customer typically keeps their machines for 10 to 20 years, and, over this time, is very likely to add new products, change products, change packaging materials, change sizes, etc.," Johnson says. Moreover, he says, "Because of the higher level of design, quality control, and validation requirements, medical machines are more expensive [than food machines, for example]. So, they must be adaptable so they can be expanded and accept additions."
As FFS machines become more complex, often integrating multiple operations, coordinating and centralizing control becomes increasingly critical. Thus, modems and Internet connections can bring added value to FFS packaging, providing remote access for such tasks as problem solving and centralizing archived data.
Remote monitoring is increasing in usage to the point where it is almost a standard feature on Bossar machines for certain applications, according to Stainton.
Adds Wren, "Remote monitoring is becoming a means of process verification for quality groups where a single person can do a line initiation for multiple machines from a single computer." He adds that the machines can be situated in different locations in a plant.
However, medical packagers should proceed with care, says Ditchfield. "Medical packagers must validate that their software is operating correctly and be certain that nothing is influencing the operations of the machine that cannot be monitored or recorded."
For this reason, Ditchfield says, medical device firms are typically hesitant to use such features to allow access by external, or even internal, users. "The simplest way to ensure that your software has not been changed or corrupted, by error or by antagonist, is to physically isolate it-- no phone line and no network connection. It is obviously essential that a complete packaging line be networked. It is, perhaps, desirable from a manufacturing perspective that such production information be transmitted upstream to component suppliers and downstream to secondary op- erations, such as sterilization and distribution." But again, he advises caution. "While this approach may be reasonable, even essential, when packaging automotive parts, it may not be acceptable to allow such access to control systems for medical packagers."
The growing, ever-changing needs of device firms are driving advances in FFS technology. And equipment makers are geared up to provide not only those developments their device firm clients need today, but also the ones they will demand down the road.
"On an ongoing basis [we're] making significant changes to machinery configurations, integrated system offerings, and control systems to meet the continuously evolving needs of our customers," says Ditchfield. The emphasis, he says, is on increasing efficiency, meeting regulatory compliance demands, and reducing costs.
PHOTO OF ABBOTT FLEXPACK COURTESY BOSSAR USA INC. (SARASOTA, FL)