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Bags and Pouches:
Hold Up to the Competition
Converted products, such as pouches and bags, may be the last heralded of the three major medical device packaging types, behind trays and form-fill-seal roll-stock. But demand for them is healthy because they satisfy a variety of needs.
The Freedonia Group Inc. (Cleveland) projects 5.7% annual growth for pouches from 1997 to 2002, reaching $336 million in the final year. Some say the market has been even better.
That might seem hard to believe, given that pouches and bags usually don't have the strength of trays and aren't as efficient a packaging process as form-fill-seal. But many companies are finding that, especially with the new materials being used, they offer the best combination of cost and quality.
Another growth market is in dental devices, says David Burland, sales manager at Techlem Medical Systems Inc. (Mississauga, ON, Canada). "They are incorporating the use of pouches in their sterilizers, and the sharper items tend to wind up in them as well."
Jerry Bennish, global marketing director for Rexam Medical Packaging (Mundelein, IL), says that the growth in the bag and pouch market mirrors that in the device market. Growth would be even higher if some companies didn't replace them with form-fill-seal operations, which are considered to be more efficient for large volumes.
And another strong area, says Phil Rosenburg, president of Technipaq Inc.(Crystal Lake, IL), is in applications that provide a foil laminate for better barrrier protection. "If you have a product that is sensitive to light, oxygen, or moisture, a lot of the time the most economical choice is a preformed pouch or bag," he says. Many of these bags and pouches use foil as their barrier, but silicon oxide, aluminum oxidem and Aclar are among the other options, he notes.
STRONG BUT NOT
While "there is not a major tidal shift away from trays," says Carl Marotta, president of Tolas Health Care Packaging (Feasterville, PA), "there are tougher films available for packaging heavier devices. They often contain nylon for puncture and abrasion resistance."
Bennish notices the same trend. "In pouches used in hospitals, there have been new films incorporating laminates that have a lower tendency to fracture or tear," he says. For instance, "there have been advances in polypropylene films that allow for extra resistance." One of the tray's advantages over the bag or pouch is its ability to hold a product in place. But bags and pouches are beginning to offer the same capability."Die-cut insert cards used inside a pouch replace the need for a tray," says Kathleen Daly Mascolo, vice president and director of sales and marketing at Beacon Converters Inc. (Saddle Brook, NJ). "They give the protection and organization of a tray but are much less expensive."
These products, Marotta says, "immobilize the part so it does not shift and push up against the side seals. That enables people to use pouches for bigger products." Another use along those lines, says Curt Larsen, packaging consultant for DuPont Medical Packaging Systems (Wilmington, DE), is to put a tray inside a pouch or header bag as a less-expensive alternative to a heavy-gauge blister package.
Bags for custom procedural kits are also required to be stronger as the kits get bulkier and heavier. Collins says that, for such heavy kits, "customers are converting to stronger films and special design features, such as a reinforced weld seal, to prevent product push through at the header seal."
Also a factor, says Burland, is that "as manufacturers are consolidating purchases and as volumes grow, products are being shipped over greater distances and more safe-transit issues arise. The bags and pouches have to be stronger and tougher while maintaining sterile integrity. So we see multilayer laminates and the use of stronger substrates and heavier gauges for more demanding applications."
The problem with
downgauging, says Larsen, is that "the purchaser or marketer who
is making this decision doesn't understand the ramifications of it and
may be circumventing the packaging engineer, if they even have one.
You can't dismiss it as 'just packaging.'" Rosenburg of Technipaq
adds that, "Even if a switch in material can give a cost savings,
there is still the reluctance to qualify new material."
Marotta agrees. "It is possible to make some pouches with it. One limitation is that it is a lighter weight grade than other Tyvek styles and tends to tear or delaminate more easily. We design around it by putting coatings on it that enable a cleaner peel."
"There have been some good papers introduced recently with much higher surface bond strength, which allows them to provide better fiber-free peel characteristics," says Eloy Cantu, global medical business development leader, Oliver Products Co. (Grand Rapids, MI). "Still, the dominant material in the U.S. market is Tyvek. It is the most consistent, the most puncture resistant, and the best bacterial barrier."
Costs can be saved another way, Bennish says. "Resin-based peel systems are replacing more expensive coated systems. That allows you to reduce cost and improve breathability by eliminating the coating of Tyvek."
With the increasing use of gamma sterilization, which is suitable for film to film pouches, there may be a rise in packages that don't use paper or Tyvek, Collins says. If a device doesn't need a permeable material, then its manufacturer may opt for the less expensive film-to-film option, he explains. To prevent the product from shifting in a film-to film pouch, a heavier material like nylon or DuPont's Surlyn might be called for, suppliers say.
However, About Packaging Robotics Inc. (Boulder, CO) has developed a machine that it says offers a way to make pouch filling more efficient. Using vacuum cups to open the pouches, the machine fills and closes them.
"There are three standard methods of operation," says Lynda Muhlbauer, the firm's administrator. "The foot pedal mode allows the operator to press a foot pedal to initiate each cycle. The timed mode cycles the system according to a prescribed number of seconds that the operator has input into the PLC. The automatic mode integrates the to an autofiller by sending a signal to the filler that the pouch has been opened and the filler should dispense product. A company can easily start with one of the manual-fill operations and upgrade to autofill when production or product changes warrant."
Despite the use of a vacuum, the machine can handle porous materials like Tyvek and paper. Since the vacuum is used only to open the bag for product insertion, the seals are not compromised.
"There will always be a place in the market for a preformed pouch or bag," Rosenburg says. "There's not one single type of package that works for every application."
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