Medical Device Link.

Originally Published PMPN July 2004

Flexible Packaging

Flexibility is increasingly important for pharmaceutical and medical device manufacturers. Flexibility in packaging, that is. Demand for flexible materials continues to grow for both industries. Manufacturers are looking for lower-cost unit packaging options, and material converters continue to improve the properties of such materials, further driving growth. 

As packagers move toward flexibles, they are asking more and more for a particular type: high-barrier clear materials. “Many companies are looking to eliminate foil so that product labeling can be read through packaging,” explains Bob Liesenfelt, director for coated laminated products at Amcor Flexibles Healthcare (Mundelein, IL). “As a result, we are seeing more interest in clear materials with maybe not the same barrier properties as foil, but as close as we can get to it.” 

Gary Bobko, vice president of sales and marketing for Glenroy Inc. (Menomonee Falls, WI), agrees. “Clear high-barrier laminates are being utilized in unique applications where barrier properties cannot be compromised, yet consumers strongly prefer to see the product. In the medical and pharmaceutical markets, this feature is of significant benefit, not only to consumers but to medical professionals who can quickly identify contents without opening and perhaps contaminating the product.”

“High-barrier packaging is of interest, especially for combination medical devices,” says Mark Miller, research engineer for DuPont Medical Packaging. “Flexible materials will have to meet the needs of these products. Traditionally, foil has been used, but there is interest in clear structures.”

Dave Gibboni, market manager for pharma flexibles at Honeywell (Morristown, NJ), says his company’s Aclar film provides not only clarity but also works with industry efforts on automatic identification. “One advantage Aclar film has over foil-based packaging is compatibility with radiofrequency identification (RFID) components,” says Gibboni. RFID use is expected to skyrocket over the next few years as pharmaceutical and perhaps even medical device packagers turn to automatic identification for anticounterfeiting and inventory- tracking initiatives.

To meet demand, material converters are customizing clear high-barrier laminations for particular applications. One such application is the new unit-dose packaging for Zicam Cold Remedy Swab, a swab applicator pretreated with a no-drip liquid nasal gel relaunched in the new packaging this year. The previous package was a nontransparent molded unit-dose tube. The product was developed by Zicam LLC (Phoenix), a subsidiary of Matrixx Initiatives Inc. 

Novel Products, Novel Films

To preserve pretreated products like the Zicam swab, high-barrier unit-dose packaging is often in order. “We have been packaging pretreated swabs into pouches with good moisture barriers, like foil laminations,” reports Nathalie Brisson, director of sales for Ropack Inc. (Montreal). “Pouches offer large printing areas for information that stays with the product throughout its shelf life.”

For the Zicam unit-dose swab package, however, Matrixx was interested in using Aclar instead of aluminum foil as the barrier material. “We wanted a cost-effective way to make the product visible, but we also needed a significant moisture barrier,” says Mike Shaw, director of operations for Matrixx. 

However, Amcor’s Liesenfelt says that Matrixx was not interested in a rigid blister or the version of Aclar typically used with PVC. “They wanted something more flexible, so we designed a nylon/Aclar/LDPE lamination formable web with a weld seal to a foil lamination top web,” he says. “It was a new development for us—we had never put this particular combination together before.” 

Doyen Medipharm Inc. (Lakeland, FL) is now producing the packaging in its contract packaging facilities. “It is a very challenging package. Not only did we have to form a very high number of interlaced cavities, but we also had to meet very tight tolerances to maintain registration throughout forming, sealing, and die-cutting,” says Ray Johnson, president of Doyen Medi-pharm. “We had less than 10 weeks to retool existing machinery, install high- precision dispensing pumps, and qualify and validate the process.”

Honeywell’s Gibboni says that Aclar is being looked at more and more for flexible packaging because of its high moisture barrier, transparency, and flex-crack resistance. It can be laminated to polyethylene (as in the Zicam swab’s case) or extrusion laminated to Barex, polypropylene, or polyester. Gibboni adds that Honeywell will be commercializing a new machine-direction-oriented (MDO) Aclar film that increases barrier by about a factor of two. “The benefit is that you can use about half as much Aclar film, which really helps the economics,” he says. 

Barred Entry

Child-resistant film/foil structures such as Alcoa’s new Pharma-Pouch P1221 can be used for unit-dose pouches.

Dhuanne Dodrill of Rollprint Packaging Products Inc. (Addison, IL) calls aluminum foil the standard when it comes to high barrier. She spoke at HealthPack 2004 in Palm Beach Gardens, FL, earlier this year, discussing high-barrier materials for packaging medical devices in her presentation, “Advances in Packaging Materials.” “Foil is virtually impervious to moisture and gas, and it has a long history of use, so it is well understood.”

John Ozcomert, PhD, director of technology for Amcor Flexibles Healthcare, agrees, calling foil “still the best barrier around.” Ozcomert spoke recently at Medical Design & Manufacturing (MD&M) East 2004 in New York City, presenting his speech, “Material Selection for Sterile Packaging Design.”

Kathleen Daly-Mascolo, vice president and director of sales and marketing for Beacon Converters (Saddle Brook, NJ), reports that her firm has been making more foil pouches than ever before. “We’ve even designed new rounded corners for foil pouches, because the squared corners can be a puncture hazard,” she says.

Advances continue to be made in foil-based flexibles. For instance, Alcoa Flexible Packaging (Richmond, VA) has introduced Alcoa Pharma-Pouch P1221, which offers significant tear resistance for child-resistant applications. Pharma-Pouch P1221 is a four-ply film/poly/foil/poly structure that provides improvements in tear and puncture resistance over similar film/foil structures. Pouches made from Alcoa’s P1221 can be opened only with scissors, which will prevent children from biting or tearing them open. The exterior film is clay coated to give it a white background, and it can be surface printed and overcoated in multiple colors for brand identification.

Clear Barriers

However, “Everyone wants clear materials with the barrier properties of foil,” says Ozcomert. “We can get close with resin-based barriers like Aclar, which may be expensive on an area basis, but delivers features like flex-crack resistance that foil lacks. People need to consider the total packaging cost, including labeling, that may make such options more palatable,” he says.

Dodrill told her audience that silicon oxide–coated films have been the solution for a long time. Some formulations, like Rollprint’s ClearFoil F, have offered better flex-crack resistance than foil; another benefit is water-vapor transmission rates (WVTR) as low as 0.02 g/100 in.2/day.
But aluminum oxide is largely replacing silicon oxide, Dodrill explained. Rollprint’s ClearFoil X, for instance, offers a WVTR of 0.002 g/100 in.2/day and oxygen transmission rates of 0.005 cm3/100 in.2/day.

Technipaq Inc. (Crystal Lake, IL) is also working with aluminum oxide coatings. “The majority of the substrates we offer are polyester-based materials that have been enhanced with aluminum oxide,” says Brian Rosenburg. “They do offer good barrier, but not quite equal to foil in a single layer. The properties do increase when a double layer is used, and can be comparable to foil. We are working with a new film that is in development that is almost identical to the barrier of foil in a single pass. We are still in development on this structure, but have one working version right now. We have the capability of running them for all types of sterilization, including retort and radiation.”

At MD&M East, Tolas Health Care Packaging (Feasterville, PA) was distributing samples of its aluminum oxide offering. The tear-open film pouch consists of two TPF-0599B aluminum oxide PET laminations sealed together.

If oxygen is a product’s biggest foe, another option is to use films with oxygen scavengers built right in. Not only do they keep oxygen from entering the package, they reduce oxygen levels inside the package, Dodrill says. The scavengers can be separated from the product with a layer of polyethylene. Oxygen-scavenging options include ferric compositions as well as oxygen-scavenging polymers that employ an oxidizable polymer, transition-metal catalyst, and a photoinitiator.

Jeff Murak, director of sales and marketing for Oliver Medical (Grand Rapids, MI), has seen demand increase for its ultraviolet light (UV)–inhibiting film called Sablock. “It is ideal for tissues sensitive to UV light,” he says.

The need for product visibility may be the driving force behind a switch to clear barriers, but downgauging may also play a role, Ozcomert said during his MD&M East presentation. “We’ve downgauged foil about as far as we can go—to 0.285 mil,” he said. 

On the film side, a trend in downgauging that Ozcomert called “upstrengthening” may be one way to save on materials, while maintaining or increasing strength. “We are using more layers in our films. For instance, instead of using 1-mil worth of nylon, we are using 0.5 mil distributed over multiple layers and bulking up with cheaper resins,” he says. “And lower-costing additives can be used to impart other features, such as abrasion resistance, whereas in the past we used thicker films or expensive resins.”

Bacteria Barriers

Oliver Medical’s Osurance is an optimal-adhesive zone-coated lid for medical packaging applications.

For porous-packaging needs, converters report that Tyvek is still on top of manufacturers’ lists. But continuing trends toward cost reduction are forcing converters to “drive costs out of packaging and produce better products for less money,” says Murak. As a result, firms like Oliver Products are constantly reinvesting in new equipment that can optimize coatings and other converting operations.

Oliver has just finished modifying its current equipment and has new equipment specified that will automate its zone coating process. “We’ve been able to automate multiple steps of our in-line coating process to cut costs,” says Murak. “The product performs the same but the cost has been reduced substantially.”

Murak adds that Oliver’s customers continue to seek material that will fill the gap between medical-grade paper and Tyvek. “MDMs continue to demand performance but are challenged to save money. Material is always the target,” he explains.

Dispensing the Goods 

In addition to barrier, however, novel products will also need new solutions for dispensing, and flexible packaging can be key in this role. The Zicam swab package, for instance, has notches on each side of the package so that users can tear across the weld seal without the need for scissors or other tools.

Sonic Packaging Industries Inc. (Westwood, NJ) is now forming hermetically sealed pouches with flow-through applicators attached. To dispense product, users twist off the tip of the flexible pouch to expose the applicator and then apply pressure to the chamber to force product through the applicator to the point of use, explains Howard Thau, president of Sonic Packaging. “There is so much interest in alternative ways to dispense oral, topical, and nasal products. Many new products are not stable in the applicator for long periods, so keeping the product separate from the built-in applicator maintains convenience and product stability.”

Sometimes the in-house innovations of suppliers affect dispensing, too. Ropack’s Brisson explains that more companies are using unit-dose flexible pouches for pharmaceutical and nutritional supplement powders. “When the product dosage is too great for a capsule, product manufacturers like to offer powders that can be placed into drinks,” she says. But some firms have had some difficulty combining two powders in one pouch because the different particle sizes of the two powders do not meter well when packages are filled from the same hopper, she adds. As a solution, Brisson reports that Ropack can install double filling units on its pouch-filling lines.

Materials converters continue to improve the properties of flexible materials, like increasing the barrier of clear materials. They are bringing costs down, too. These innovations are helping manufacturers bring novel products to market, like the Zicam Cold Remedy Swab. 

Copyright ©2004 Pharmaceutical & Medical Packaging News