Getting More from Bag and Pouch Materials
Advances in strength, barrier, and even security are now routine offerings.
|Amcor Healthcare Flexibles’ extrusion equipment is designed to process resins more efficiently.|
As healthcare product technology races on, so does the technology behind bags and pouches. Factors such as the introduction of new types of devices and kits, in addition to the never-ending search to reduce costs, are leading medical companies to ask more of their flexible medical packaging. They want tough, high-barrier materials, the option to use steam sterilization, and even anticounterfeiting measures.
Sandwiched for Performance
Sometimes meeting demands for strength and barrier protection involves making a kind of materials sandwich, adding different layers depending on the barrier protection or other properties needed in the finished bag or pouch. The layers themselves are not new, but the combinations often are.
“Materials are evolving every day from a technology standpoint,” says Jeff Murak, director of sales and marketing, Oliver Medical (Grand Rapids, MI). One example Murak offers is Oliver’s pairing of its Sablock film, for UV protection, with aluminum oxide, to offer a moisture barrier. In some cases, converters are also making pouches with materials not historically used, such as puncture-resistant nylon films.
Sometimes the objective is cost savings as much as performance. “Everyone’s always looking to downgauge,” says Dhuanne Dodrill, president and COO of Rollprint Packaging (Addison, IL). Rollprint is offering new options in its clear foil line, with barriers that Dodrill says sometimes exceed that of thin-gauge foils. In some cases, the cost is also less. “There’s really a misconception out there that aluminum foil is going to be less expensive,” says Dodrill.
Materials such as COC and Aclar are now easier to incorporate into coextrusions and laminations, so that they can be used in bags and pouches, reports Chris Heezen, director of regional sales at Amcor Healthcare Flexibles (Mundelein, IL). Two years ago, the company began to sell clear bags and pouches with these high-barrier materials. “We’ve added extrusion equipment that can process the resins more efficiently,” Heezen says.
Perfecseal (Oshkosh, WI) has also invested in film lines that can extrude several layers and lower materials costs, according to Ed Haedt, vice president of marketing. One example is the company’s surgical kit bags made from new films that incorporate nylon. “Typically, these bag films are made from LLDPE or blends of LLDPE and mLLDPE, but we are finding that by using even a small amount of nylon, our puncture and abrasion resistance allows us to downgauge [by] as much as 25% versus the competition,” says Haedt.
Ways Around the Tray
Materials are now engineered with such strength that device makers are sometimes able to eliminate rigid trays within pouches. “Compartment pouches, special bumper pouches, and three-dimensional packaging all offer the device company additional safety features for considering flexible versus rigid packaging to reduce costs,” says Leslie Love, director of sales and marketing at Tolas Healthcare Packaging (Feasterville, PA). “Additionally, the wider variety of puncture-resistant and barrier packaging used in conjunction with these [alternatives to trays] gives many device and pharmaceutical companies further options.”
Getting rid of the tray offers a number of advantages, according to Kathleen Daly Mascolo, vice president and director of sales and marketing at Beacon Converters (Saddlebrook, NJ). For companies marketing their devices globally, environmental considerations and regulations—especially in Europe—dictate the use of reduced packaging wherever possible, Mascolo explains.
Eliminating trays also reduces cost, and the bulk of the package, which decreases time needed for sterilization. “The less bulky the package, the more room available on the sterilizer,” says Mascolo. Alternatives to rigid trays include double pouching and the use of die-cut insert cards to keep the device in place.
Building Up Steam
Another item being developed to give medical OEMs lower-cost options is the steam sterilizable pouch. Previously, pouches were marketed only for in-hospital applications. But now many device makers are looking for the same lower-cost sterilization option.
Rollprint is one company responding with new products. They now offer PropaPeel A, a sealant applied to uncoated paper to create a steam sterilizable pouch just for medical OEMs. PropaPeel A has been used as a lidding material and to create autoclave pouches. But recently the company saw the increasing demand for steam in the device market and began applying it to uncoated paper. “We’ve found that it works really well with the uncoated paper,” says Dodrill. The product’s first commercial application is likely coming by the spring of this year.
Because PropaPeel A is an extrusion-coated sealant, rather than a laminate or adhesive, it offers time and cost savings as well. The pouches can make use of less-expensive raw materials, run faster, and allow for use of a physically wider web than laminates, says Dodrill.
New Devices—New Demands
|A tandem coextrusion coater/laminator from Amcor Healthcare Flexibles.|
Demands on bag and pouch materials have also been boosted by the development of implantable devices coated with drugs or other organic or biologic materials. “Those all require premade packaging, and they require interesting combinations of sterilization methods,” says Amcor’s Heezen. These devices are produced in volumes too low to make in-line packaging economical, he explains, so demand has increased for premade bags and pouches that meet their special requirements.
Both Amcor and Perfecseal supply premade bags that incorporate high-barrier foil to offer protection for the coating and a strip of breathable material that allows for EtO sterilization that can be sealed over and removed. “In addition, we need to make sure the inner surface of the packaging material is compatible with the drug or biologic and does not interact with the drug,” says Perfecseal’s Haedt. “In essence, the package must satisfy both medical and pharmaceutical requirements.”
Tolas is working on an additional feature to help protect against moisture and oxygen exposure. “Our newest product under development is a pouch with an internally housed desiccant pocket,” says Love. “The pouch is made of a barrier foil outside with a Tyvek 2FS inside desiccant pocket.”
A Bigger Bag
Driving the continued demand for premade bags, according to Heezen, is the increasing size of custom hospital kits and surgical kits. These, like drug-coated implantables, are often produced in volumes too low to justify package automation. Also, their large size often makes automation difficult. “Some of them are bigger than the machines that would be able to package them,” Heezen says.
Amcor has increased its capabilities in the area of vented bags with single and double vents to allow for EtO sterilization of large-sized kits. “Even with a big, bulky item inside, you get good circulation of EtO gas,” says Heezen. Because the kits are meant to be opened in a surgical environment, facilitating package access (i.e., tearing or peeling) is also important, “especially as packs and custom kits have gotten larger and larger,” says Heezen.
Traceability and Counterfeiting
One of the newest features being developed by packaging suppliers is the ability for users to verify that the pharmaceutical or medical device is authentic. “One of the big concerns we’re hearing from a lot of our customers is counterfeiting,” says Tim Groff of Automated Packaging Systems (Streetsboro, OH), adding that the company is currently working to address traceability and counterfeiting issues.
In November last year, Automated Packaging debuted a product that applies RFID tags to pharmaceutical and medical device bags. As an added layer of protection, the company is also working to create materials with a unique signature that will allow distributors to verify that the product is authentic.
“Our objective is to have it be a very simple process, just like a bar code scan,” Groff says. He believes that counterfeiters would have a difficult time duplicating this bagging material, which has a signature that can be changed “on the fly.” “That to us is the ultimate security measure,” says Groff. “We’re trying to drive authenticity down to the bag material level.” The company hopes to make an announcement about this product sometime in the near future.
Of course, as quickly as current demands on materials are met, new devices and requirements will mean that new ones arise. And it is in technical capabilities that the bag and pouch industry shows promise. As high-volume commodity packaging moves offshore, U.S. companies can find new opportunities in the area of high-tech, yet lower volume, applications, says Heezen. “That’s really where the growth is going to be.”